World Health Day

World Health Day

Every year, World Health Day is celebrated on April 7 under the auspices of the World Health Organization (WHO), as well as other related organizations.

This year, World Health Day i.e. April 7, 2020, will focus on the vital role played by nurses and midwives in providing healthcare worldwide. It will highlight the current status of nursing across the globe. WHO and its partners would make a series of recommendations to strengthen the nursing and midwifery workforce.

This world health day, we pay tribute to the contribution of nurses and midwives for their vital role in keeping the world healthy. Nurses and other health workers who are at the frontlines in providing the treatment and care to patients suffering from novel coronavirus (COVID-19) outbreak by putting their own health at risk to protect the community.

We are thankful for their commitment and hard work for saving lives!

Cutaneous T-cell Lymphoma (CTCL): Market Size & Forecast

Cutaneous T-cell Lymphoma (CTCL): Market Size & Forecast

Disease Overview

Cutaneous T-cell Lymphoma (CTCL) is the most common type of skin lymphoma. CTCL is rare cancer that begins in white blood cells called T cells (T lymphocytes) and these the T cells develop abnormalities that make them attack the skin. It appears as an eczema-like skin rashes and can affect widespread parts of the body.

There are different types of Cutaneous T-cell Lymphoma (CTCL). Mycosis Fungoides and Sezary syndrome are the most frequent type of Cutaneous T-cell Lymphoma (CTCL). The other forms of cutaneous lymphoma include the CD30 positive lymphoproliferative disorders (CD30+ LPDs), subcutaneous panniculitis-like T-cell lymphoma, Primary cutaneous CD4+ small/medium pleomorphic T-cell lymphoma, Primary cutaneous gamma/delta T-cell lymphoma, Extranodal natural killer/T-cell lymphoma, nasal type, and others.

The World Health Organization (WHO) and the European Organization for Research and Treatment of Cancer (EORTC) Classification

Indolent Clinical Behavior Aggressive Clinical Behavior
Mycosis fungoides Sézary syndrome  
Subcutaneous panniculitis-like T-cell lymphoma Primary cutaneous CD8+ aggressive epidermotopic T-cell lymphoma  
Primary cutaneous CD4+ small/medium pleomorphic T-Cell lymphoma   Primary cutaneous gamma/delta T-cell lymphoma  
CD30+ Lymphproliferative Disorders Primary cutaneous anaplastic large cell lymphomaLymphomatoid papulosis   Extranodal natural killer/T-cell lymphoma, nasal type  

Epidemiology

According to the CmaxInsight, the total incident cases of Cutaneous T-cell lymphoma (CTCL) were calculated to be around 9,000 in 2018 in 7MM including the United States, EU5 countries (the United Kingdom, France, Italy, Spain, and Germany) and Japan. The United States accounts for the highest incident cases of 3,430  in 2018 followed by EU5 countries, and Japan According to the National Organization for Rare Disorders (NORD), the Cutaneous T-cell lymphoma (CTCL) affects males twice as often as females. The majority of the CTCL cases are diagnosed between the age-group of 40 to 60 years. Further, it is expected that the incident cases of the CTCL would increase over the forecasted period.

Market Size

According to the Cmaxinsight, the market size of Cutaneous T-cell Lymphoma (CTCL) is growing at a CAGR of 5.54% for the forecasted period 2018-2028 in 7MM including the United States, EU5 countries (the United Kingdom, France, Italy, Spain, and Germany) and Japan. The United States accounts for the highest market share of around 40% in 2018 followed by EU5 countries, and Japan. The market is dominated by the availability of topical therapies, including corticosteroids, retinoids, different chemotherapy regimens, and others. The market is driven by rising incident cases, the expected launch of emerging therapies, technological advancement, and improving healthcare facilities.

Competitive Analysis

The market is dominated by the availability of the marketed drugs such as Istodax (Celgene Corporation), Poteligeo (Kyowa Hakko Kirin Co. Ltd), Valchlor/ Ledaga (Actelion), Uvadex (Mallinckrodt Pharmaceuticals), Targretin (Eisai Co., Ltd.), and Zolinza (Merck Sharp & Dohme Corp), and others. The expected launch of emerging therapies such as Quisinostat (Janssen), Remetinostat (Medivir AB), denileukin diftitox (Eisai Co., Ltd) and others shall have a positive impact on the market.

The companies are entering into the mergers, acquisitions, collaborations and other activities for increasing their market penetration. In January 2020, the Almirall had entered into an option agreement to acquire Bioniz Therapeutics and to establish a broad research agreement to further expand its innovative pipeline in medical dermatology. This collaboration would allow Almirall to executes its strategy to develop and expand its R&D pipeline with new treatment modalities with the objective to address highly underserved diseases within oncodermatology and immunodermatology.

Impact of Coronavirus (COVID19) on India Pharmaceuticals

Impact of Coronavirus (COVID19) on India Pharmaceuticals

India is one of the largest providers of generic drugs worldwide. India pharmaceutical industry supplies approximately 50% of vaccines worldwide, 40% of generics in the United States and 25% of all medicines in the United Kingdom. India exports bulk drugs, intermediates, drug formulations, biologicals, Ayush & herbal products, and surgicals to various countries.

According to the India Brand Equity Foundation (IBEF), the Indian pharmaceutical sector had a market size of USD 33 Billion in 2017. India’s pharmaceutical exports had witnessed an increase from USD 19.14 Billion in 2019 to USD 17.27 billion in 2018.

The novel coronavirus (COVID-19) outbreak had a negative impact on the India pharmaceutical industry in the following ways:

  • India has restricted the export of several drugs such as paracetamol, antibiotics such as tinidazole and erythromycin, hormone progesterone, which is used in the contraceptive pill, and vitamins B12, B1 and B6. These drugs account for approximately 10% of all India’s pharmaceutical exports.
  • The Indian government have imposed limits on the export of 26 pharmaceutical ingredients
  • Indian pharmaceutical companies are now close to exhausting their supply of raw materials such as active pharmaceutical ingredients (APIs). Moreover, the inventories related to the pharmaceutical ingredients are running low.
  • Several pharmaceutical companies who have contracts with domestic clients and various state governments to supply medicines have been crippled, as manufacturing has come to a halt due to a shortage of raw materials from China
  • Pharmaceutical companies are not able to procure pharmaceutical ingredients for Mintelukast, used for asthma, pain medication Nimesulide, and Amoxicillin, Ofloxaicin, and Chloramphenicol, which are used to treat bacterial infections, and antibiotic Metronidazole
  • Small and medium companies have been most  affected as they depend on traders and keep lower inventory
  • There is a drastic increase of 20-30% in the prices of raw materials used in medicines like Amoxicillin and Paracetamol.
  • The pharmaceutical logistics is facing the difficulties in receiving the raw material from other parts of the country

Coronavirus Outbreak

Coronavirus Outbreak

Coronaviruses Description

Coronaviruses are a family of viruses that lead to respiratory illness, including the Middle East respiratory syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS). It is common in many different species of animals, including camels, cattle, cats, and bats. Rarely, animal coronaviruses can infect people and then spread between people such as with MERS-CoV, SARS-CoV, and now with this new virus (named SARS-CoV-2). The SARS-CoV-2 virus is a betacoronavirus, like MERS-CoV and SARS-CoV.  All three of these viruses have their origins in bats. Similar infections are caused by human alpha and beta coronaviruses such as 229E, NL63, OC43, and HKU1.

The symptoms associated with coronavirus are the common cold, such as running nose, headache, cough, fever, and sore throat. Viruses can spread from human contact with animals. According to the World Health Organisation (WHO), scientists think MERS started in camels. Officials do not yet know what animal may have caused the current outbreak in Wuhan.

Human-to-human transmission has been confirmed for the Wuhan coronavirus, but depending on how virulent the virus is, a cough, sneeze or handshake could cause exposure. The virus can also be transmitted by touching something an infected person has touched and then touching your mouth, nose or eyes. Caregivers can sometimes be exposed by handling a patient’s waste, according to the Centers for Disease Control and Prevention (CDC). Furthermore, SARS and MERS were largely transmitted inside hospitals. Some people are also considered to be “super spreaders.”

Current Scenario

The novel coronavirus (COVID-19) was first discovered in Wuhan, China in December 2019, since then, it has affected more than 400,000 people and caused 18,440 deaths according to the World Health Organization (WHO)’s recent situation report.

The seafood market of Wuhan was identified as the suspected hub of the coronavirus outbreak by the United States Centers for Disease Control and Prevention (CDC).  Now, there have been more new cases reported from countries outside of China than from China. Two new countries/territories/areas from the Western Pacific Region and the Eastern Mediterranean Region have reported cases of COVID-19.

The mysterious novel coronavirus outbreak was identified by Chinese authorities on January 7 and since named COVID-19, is a new strain that had not been previously identified in humans. The coronavirus (COVID-19) outbreak poses a significant life-threatening and economic risk throughout the world. Over 414,179 cases have been diagnosed across 48 countries, resulting in over 18,440 reported deaths. As far as concern, due to this contagious coronavirus outbreak death has been confirmed in Hong Kong, the Philippines, Japan, France, Iran, Taiwan, South Korea, and other countries. On 31st January 2020, officially WHO has declared it a global health emergency, due to increases number of infectious cases has been confirmed in countries such as South Korea, Afghanistan, France, UAE, and many more countries.

The mortality rate is mostly within 2%~3%, well in line with the WHO official estimate. For example, MERS, SARS and the Wuhan coronavirus appear to cause more severe disease in older people Age group 60-69 years old at 3.6%, 50-59 years old at 1.4% & least 40-49 years old at 0.4%, though uncertainty remains around the latest outbreak. Of the cases of Wuhan coronavirus reported so far, none are yet confirmed to be among children.

Treatment Landscape

Several vaccines, antibiotics & anti-retroviral drugs such as FTNX-1800 (Tonix Pharmaceuticals), Leronlimab (CytoDyn), etc. are undergoing the clinical trials for coronavirus outbreak. Apart from this novel therapies, supportive therapy is also recommended including over the counter medicine for a sore throat, fever & pain reliever medications, etc. to relieve the symptoms, if happens. Additionally, drink plenty of fluids, get rest and sleep as much as possible is recommended.

Government Initiatives

The government has taken initiative to allocate the emergency funds for improving public health to curb the current global coronavirus outbreak. For instances, The Trump Administration is looking to allocate approximately $2.5 billion in emergency funds to help prepare the country should the current coronavirus crisis become a public health care threat in the U.S. Other governments and global health authorities are taking similarly aggressive steps to prepare for the virus’s continued spread. Furthermore, the UK government like Health Secretary Matt Hancock has announced that £20m in Government funding will be given to the Coalition for Epidemic Preparedness Innovations (CEPI) to advance programmes targeting the coronavirus.

FDA Approved Drugs: February 2020

FDA Approved Drugs: February 2020

Pizensy (lactitol): Braintree Labs

Pizensy (lactitol) is an osmotic laxative therapy indicated for the treatment of chronic idiopathic constipation (CIC) in adults. Pizensy will be supplied as a powder for oral solution as 280 grams and 560 grams of lactitol in multi-dose bottles, as well as 28 unit-dose packets each containing 10 grams of lactitol. The product can be mixed with the patient’s fluid of choice and is taken once daily, preferably with meals. Pizensy is expected to be available in the United States in H2 2020. Pizensy is a New Chemical Entity and is expected to have patent protection until 2037.

Nexletol & Nexlizet (bempedoic acid and ezetimibe): Esperion Therapeutics

Nexletol is a first-in-class ATP Citrate Lyase (ACL) inhibitor that lowers LDL-C by inhibition of cholesterol synthesis in the liver. Nexletol will be commercially available in the United States by March 30, 2020. Nexlizet is a combination of an adenosine triphosphate-citrate lyase (ACL) inhibitor, bempedoic acid, and ezetimibe, a cholesterol absorption inhibitor. The FDA approval of Nexletol and Nexlizet provides an important option for patients living with elevated LDL-C and ASCVD or increased risk for cardiovascular disease. High LDL, or bad cholesterol, is one of the top risks for heart attacks and other problems.

Barhemsys (amisulpride):Acacia Pharma

Barhemsys is the first and only antiemetic approved therapy for the ‘rescue treatment’ (patients who are uncontrolled following prophylactic treatment with standard-of care-antiemetics) and prophylaxis of Postoperative Nausea and Vomiting (PONV) in patients who have failed prior prophylaxis using current standard of care. It is an intravenous formulation of the selective dopamine D2 and D3 antagonist amisulpride (2.5 mg/mL).

Nurtec ODT (rimegepant):Biohaven Pharmaceuticals

Nurtec ODT is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist available in a fast-acting orally disintegrating tablet (ODT).The approval of Nurtec ODT was based on efficacy data from a randomized, double-blind, placebo-controlled Phase III trial that compared Nurtec ODT with placebo in 1466 adult patients for the acute treatment of migraine with and without aura. Nurtec ODT will be supplied as 75mg orally disintegrating tablets in a blister pack of 8 and is expected to be available in early March 2020.

Novel Coronavirus (COVID-19) Recent Updates

Novel Coronavirus (COVID-19) Updates

FDA Approves First Rapid Point-Of-Care COVID-19 Diagnostic Test

Sunnyvale-based molecular diagnostic company Cepheid received FDA approval for the first rapid coronavirus test with a 45-minute detection time. This test will be used primarily in hospitals and emergency rooms.

Abbott receives FDA Emergency Use Authorization and Launches Test to Detect Novel Coronavirus

Abbott has received FDA emergency use authorization for a molecular test for novel coronavirus (COVID-19). The Abbott m2000 RealTime System is a molecular solution featuring a broad menu of tests, including ones for infectious diseases. The platform uses polymerase chain reaction (PCR) technology, which amplifies a single piece (or few copies of a piece) of DNA to quickly and accurately diagnose a patient. The m2000 is currently used in labs around the world.

Roche begins shipments of first 400,000 COVID-19 tests to laboratories across the US to begin patient testing under FDA Emergency Use Authorization

Roche plans to ship an additional 400,000 tests per week to the laboratory testing sites across the nation that are set up to run the test immediately under the guidelines of the FDA Emergency Use Authorization (EUA). The Cobas SARS-CoV-2 Test provides reliable and high-quality results for clinical decision-making for the improved management of COVID-19 patients and to reduce the risk of SARS-CoV-2 (coronavirus) infection. These highly automated tests provide results in 3-½ hours.

Eli Lilly teams with Indiana Health Agency to provide speedy Coronavirus Testing to Indiana Residents

Eli Lilly teams with the Indiana State Department of Health (ISDH) to rapidly expand and accelerate testing for the SARS-CoV-2 coronavirus in Indiana.

Thermo Fisher plans to produce up to 5 million of a new test to detect the Novel Coronavirus

Thermo Fisher, the largest maker of scientific tools, plans to produce up to 5 million of a new test to detect the novel coronavirus that causes Covid-19. The Food and Drug Administration granted the new test an emergency use authorization status.

*Emergency Use Authorization (EUA): Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives.

FAQ on the Coronavirus Disease (COVID-19)

Frequently Asked Questions on the Coronavirus Disease (COVID-19)

Disease Description

What is COVID-19 (novel Coronavirus)?

Coronaviruses (CoV) are a large family of viruses that cause illness ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). Recently, an outbreak of a new coronavirus disease now called COVID-19. Coronavirus disease (COVID-19) is a new strain discovered in 2019 and has not been previously identified in humans.

Was new coronavirus deliberately created or released by people?

Neither, the coronavirus was deliberately created nor released by people. The virus undergoes genetic changes and the disease outbreak occurs only when a virus presents in animals such as pig, bat or bird undergoes changes and passes to humans.

How does COVID-19 spread?

Like the flu, COVID-19 can be transmitted from person to person. Whenever an infected person coughs, sneezes or talks, they may generate droplets containing the virus. These droplets are too large to stay in the air for long, so they quickly settle on surrounding surfaces. The infected person can spread virus through coughing and sneezing, close personal contact especially in a household workplace, health care centre,restaurant or during travelling etc., contact with an object or surface with viral particles on it and then touching your mouth, nose or eyes.

How long does it take for symptoms of the COVID-19 to appear?

The symptoms of COVID-19 may appear in as few as two days, or as long as 14 days after exposure.

Are few people more at risk than others?

Elderly people and patients with health conditions such as hypertension, diabetes, cardiovascular disease, chronic respiratory disease, and cancer are the high risks of developing severe symptoms. There is limited information is available regarding the people groups which are prone to a more severe outcome following infection with 2019-nCoV.

Are children also at risk of infection?

According to the China study the disease development is relatively rare and mild in children. Approximately, 2% of COVID-19 cases were observed among the age-group under 18 years.

Medical Diagnosis and Treatment

When should I seek medical advice?

If you are experiencing any symptoms then, please consult your physician or Healthline number as soon as possible.

Is there any vaccine available for a novel coronavirus?

Currently, there is no vaccines available for novel coronavirus disease. It would take a number of years for a new vaccine to be developed. However, many companies are conducting clinical trials for developing the vaccine for the treatment of novel coronavirus disease.

Is there any treatment for a novel coronavirus?

Currently, there are no FDA approved therapies for COVID-19. Only supportive therapies such as oxygen therapy, fluid management and antivirals are recommended for the treatment of clinical symptoms associated with the novel coronavirus. Supportive care for vital organ functions are recommended for the management of severe cases.

Preventive Measures

What can I do to protect myself?

Follow the standard recommendations to reduce exposure and transmission of Coronavirus

Wash your hands often with soap and water for at least 15-20 seconds. Additionally, use a hand sanitizer with at least 60% alcohol.

Avoid touching your eyes, nose and mouth with unwashed hands.

Avoid close contact (within 6 feet) with people who are sick.

Stay home when you are sick.

Cover your cough or sneeze with a tissue, then throw the tissue in the trash.

Standard household cleansers and wipes are effective in cleaning and disinfecting frequently touched objects and surfaces.

What should I do if I have had close contact with someone who has COVID-19?

You should inform the public health authorities in your area who will provide guidance on further steps to take. Meanwhile, if you develop any symptoms, you should immediately call your healthcare provider for advice, mentioning that you have been in contact with someone with COVID-19.

Are face masks effective in protecting against COVID-19?

If you are infected, the use of face masks may reduce the risk of you infecting other people. In fact, it helps the non-infected person to keep a distance (at least one meter) from an infected person which can add to the prevention of infection. However, there is no scientifically evidence found which showed that face masks would effectively prevent one from being infected with the virus. If you are not infected or sick then there is no need to wear a facemask unless you are caring for someone who is sick (and not able to wear a facemask). Hence, it is possible that the use of face masks may even increase the risk of infection due to a false sense of security and increased contact between hands, mouth, and eyes

When should I stay at home?

If you feel sick, you should stay at home. Meanwhile, if you are experiencing severe symptoms you must consult from the physician as soon as possible.

 Can I go overseas? Are there any travel restrictions?

Before planning any international trip, you may check the Safe Travel website for the latest advice from the Ministry of Foreign Affairs and Trade (MFAT).

Can Mosquitoes Transmit the Coronavirus?

Mosquitoes and ticks can’t spread all types of viruses. There are not any studies demonstrating the spread of COVID-19 or other similar coronaviruses through mosquitoes or ticks. It is necessary for the virus to replicate inside the mosquito or tick to pass to a person through a mosquito or tick bite.

Can the COVID-19 virus be transmitted in areas with hot and humid climates?

As per the several studies, the COVID-19 virus can be transmitted in all areas including areas with hot and humid weather.

Can I get coronavirus from a package delivered or brought from China?

No, you cannot get coronavirus from a package delivered or brought from China. Coronavirus can be transmitted by droplets from an infected person’s sneeze or cough and other sources.

Emerging Therapies for Coronavirus

Over the last few days, the coronavirus outbreak has spread to other countries such as China, South Korea, Italy, Iran, Japan, Singapore, Hong Kong, the United States, and other countries. It has endangered thousands of lives in a short span of time. Hence, several pharmaceutical & Biotech companies are focusing on the development of novel therapies for the treatment of coronavirus.

Coronavirus outbreak begins to boosting the development of new treatment. The pipeline landscape of the coronavirus is robust with the involvement of several therapies such as vaccines, antibiotics, anti-viral therapies, mesenchymal stem cell (MSC) derived and other therapies for the treatment of coronavirus.

Several pharmaceutical & Biotech companies have entered into the collaboration with the National Institutes of Health (NIH), for the development of novel coronavirus therapies.

Pipeline Therapies for the treatment of Coronavirus

Vaccine

Pharmaceutical companies are developing coronavirus vaccines that have the potential to become a substantial treatment for the contagious coronavirus infection across the world. There are major drugs in the pipeline that have the potential to address the Wuhan outbreak as follows

TNX-1800 (Tonix Pharmaceuticals)

Tonix Pharmaceuticals has entered into the collaboration with Southern Research to develop a Potential Vaccine to Protect against New Coronavirus Disease 2019 (COVID-19) based on HorsepoxVirus (TNX-1800) using Tonix’s proprietary Horsepox Vaccine Platform. Horsepox is closely related to vaccinia vaccines, which are a group of orthopoxviruses that have been used as smallpox vaccines. TNX-1800 is designed to express a protein derived from the virus that causes the coronavirus infection. Under the terms of the agreement, Southern Research will be responsible for evaluating the efficacy of the vaccine.

INO-4800 (Inovio Pharmaceuticals and Beijing Advaccine Biotechnology)

Inovio Pharmaceuticals has partnered with Beijing Advaccine Biotechnology Company for the development of INO-4800,  a novel coronavirus vaccine through Phase I human testing in the U.S. to evaluate safety and immunogenicity. The Company has begun testing and clinical product. Preclinical manufacturing preparations are underway. The company has received the grant up to $9 million from the Coalition for Epidemic Preparedness Innovations (CEPI) for initiating the testing of INO-4800.

Collaboration with Beijing Advaccine Biotechnology Company would enable the Inovio Pharmaceuticals to rapidly develop its new vaccine by running parallel Phase I trials in China.

Recombinant Subunit Vaccine (Clover Biopharmaceuticals)

Clover Biopharmaceuticals is developing a recombinant subunit vaccine using its patented Trimer-Tag technology. The company is developing the vaccine based on the trimeric S protein (S-Trimer) of the 2019-nCoV virus, which is responsible for binding with the host cell and causing a viral infection.

Using this technology, Clover successfully produced the subunit vaccine in a mammalian cell-culture based expression system. The company also identified antigen-specific antibodies in the serum of fully recovered patients who were previously infected by the virus. A highly purified form of the S-Trimer vaccine is expected to be available in six to eight weeks for performing pre-clinical studies. The company is equipped with in-house cGMP biomanufacturing capabilities to scale-up production if the vaccine is proven to be successful.

Clover has entered into the collaboration with collaborated with GlaxoSmithKline plc. Under this research collaboration, the companies would evaluate Clover’s protein-based coronavirus vaccine candidate (COVID-19 S-Trimer) with GSK’s pandemic adjuvant system. GSK’s pandemic adjuvant system would help further assess COVID-19 S-Trimer in preclinical studies.

According to GSK Vaccines Chief Medical Officer, “We are proud to contribute to cutting edge research from scientists at Clover Biopharmaceuticals in China as part of our strategy to make our adjuvant technology available to selected partners who have a promising vaccine candidate against the newly emerged coronavirus.”

Linear DNA Vaccine (Applied DNA Sciences and Takis Biotech)

Applied DNA Sciences Inc., has expanded its existing Joint Development Agreement (JDA) with Takis Biotech for the preclinical development of a linear DNA vaccine against 2019-nCoV, the new coronavirus.

The PCR-produced linear DNA would provide advantages such as high purity, increased production speed, and absence of antibiotics and bacterial contaminants. Moreover, the vaccine is effective to be inserted into the patient’s genome.

MERS Coronavirus Vaccine  (Novavax)

A novel Middle East Respiratory Syndrome (MERS) coronavirus vaccine is under development by Novavax. It acts by binding to the major surface S-protein and developed using the company’s recombinant nanoparticle vaccine technology.

It is a crucial target for coronavirus vaccine development by the Coalition for Epidemic Preparedness Innovations (CEPI) and is a priority disease for the World Health Organisation (WHO). The company plans to conduct the human trials in 2020 and Phase I clinical trial planned in late spring. It is tested along with the Novavax’s proprietary adjuvant Matrix-M, it inhibited infection by inducing immune responses in the laboratory studies.

INO-4700 (Inovio Pharma)

InovioPharma in partnership with GeneOne Life Science has developed, INO-4700 (GLS-5300) the investigational DNA immunotherapy Drug. It is delivered as intramuscularly, using the Cellectra delivery device. The vaccine was well-tolerated and demonstrated high immune responses against the MERS-CoV in 94% of patients in the early-stage clinical trial in July 2019. It has generated broad-based T cell responses in 88% of the subjects.

mRNA-1273 (Moderna)

Moderna has released the first batch of its vaccine i.e. mRNA-1273 for human use. mRNA-1273 is an mRNA vaccine against the novel coronavirus encoding for a prefusion stabilized form of the Spike (S) protein complex is necessary for membrane fusion and host cell infection and has been the target of vaccines against the coronaviruses responsible for Middle Eastern Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS), which was selected by Moderna in collaboration with investigators at the NIAID Vaccine Research Center (VRC).

National Institute of Allergy and Infectious Diseases (NIAID) and National Institutes of Health (NIH) is planning to conduct the phase I study of  mRNA-1273 in the United States. The manufacture of this batch was funded by the Coalition for Epidemic Preparedness Innovations (CEPI).

Small Molecule

The article, “Therapeutic options for the 2019 novel coronavirus (2019-nCoV) “, published by the British magazine, Nature Reviews Drug Discovery, on February 10, 2020, suggests that existing anti-HIV and anti-HCV drugs may have inhibitory effects against novel coronavirus.

Brilacidin (Innovation Pharmaceuticals)

Innovation Pharmaceuticals signed a Material Transfer Agreement (MTA) with one of the country’s 12 Regional Biocontainment Labs (RBLs) to research its lead defensin mimetic drug candidate, Brilacidin, as a potential novel coronavirus treatment. Brilacidin has demonstrated antibacterial, anti-inflammatory and immunomodulatory properties in viral infections, including inhibition of SARS-CoV-2, the virus responsible for COVID-19. It is also used in several other clinical trials. The Company is planning to explore research collaborations and seek federal grants to develop the coronavirus drug. It is already investigating the drug for inflammatory bowel disease and oral mucositis in cancer patients.

Remdesivir (GS-5734)  (Gilead Sciences in collaboration with NIH)

National Institute of Health has begun the randomized, controlled clinical trial for evaluating the safety and efficacy of antiviral remdesivir among hospitalized adults diagnosed with coronavirus disease 2019 (COVID-19).

The trial has been initiated at the University of Nebraska Medical Center (UNMC) in Omaha. The first trial participant is an American who was repatriated after being quarantined on the Diamond Princess cruise ship that docked in Yokohama, Japan and volunteered to participate in the study.

According to The New England Journal of Medicine (NEJM), the administration of remdesivir improved the clinical condition. GlaxoSmithKline had entered into the collaboration with Gilead to develop an effective treatment against the coronavirus as confirmed cases of the novel coronavirus are rising.

Galidesivir (Biocryst Pharma in collaboration with NIH)

BioCryst is developing galidesivir in collaboration with the US Government Agencies and other institutions. The antiviral drug Galidesivir (BCX4430) has shown broad-spectrum activity against a wide range of pathogens including coronavirus. It is a nucleoside RNA polymerase inhibitor that disrupts the process of viral replication.  A Phase I clinical safety and pharmacokinetic study in healthy subjects has been completed and in animal studies. 

Galidesivir has also demonstrated broad-spectrum activity in vitro against more than 20 ribonucleic acids (RNA) viruses in nine different families, including filoviruses, togaviruses, bunyaviruses, arenaviruses, paramyxoviruses, coronaviruses, and flaviviruses.

Lopinavir (AbbVie)

AbbVie’s Lopinavir HIV protease inhibitor is being studied along with ritonavir for the treatment of MERS-CoV and SARS-CoV. This combination therapy is believed to act on the intracellular processes of coronavirus replication.

Darunavir/Cobicistat (Johnson & Johnson)

Pharmaceutical giant Johnson & Johnson is working to develop a vaccine for the emergent coronavirus identified last month in Wuhan, China, launching initial efforts to construct from the virus’ genetic sequence a candidate that could be tested in humans.

Janssen Pharmaceutical (a subsidiary of Johnson & Johnson) donated its PREZCOBIX HIV medication (darunavir/cobicistat) for use in research activities aimed at finding a treatment for Covid-19.

Ascletis Pharmaceuticals Co., Ltd.

Hangzhou-based Ascletis Pharma applied to the Chinese authorities to test two HIV protease inhibitors (ritonavir and ASC09) in clinical trials to treat COVID-19. Another combination therapy, Ganovo (danoprevir) and Ritonavir, is in development by Ascletis Pharma in collaboration with Ninth Hospital of Nanchan.

Antibody

Leronlimab (CytoDyn)

CytoDyn is examining leronlimab (PRO 140), a CCR5 antagonist, as a potential coronavirus drug. The drug is already being investigated in Phase II clinical trials for treatment for HIV and has been awarded fast-track approval status by the Food and Drug Administration (USFDA).

REGN3048-3051 (Regeneron in collaboration with NIH)

Discovered by Regeneron, the combination of neutralizing monoclonal antibodies REGN3048 and REGN3051 is being studied against coronavirus infection in a first-in-human clinical trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID). The safety and tolerability of the drug will be studied in 48 patients.

Novel Therapies

MSCs-derived exosomes (Cellular Biomedicine Group)

Cellular Biomedicine Group conducted a Phase I clinical trial (NCT04276987) for MSC –derived exosomes to explore the safety and efficiency of aerosol inhalation of the exosomes derived from allogeneic adipose mesenchymal stem cells (MSCs-Exo) in severe patients with novel coronavirus pneumonia (NCP).

BXT-25 (Bioxytran)

US-based biotechnology company Bioxytran has announced plans to develop a peptide-based therapy, BXT-25, to treat late-stage patients infected with the new coronavirus who have acute respiratory distress syndrome (ARDS). The diffusion of oxygen to the blood is comprised of patients suffering from ARDS leading to fluid build-up in the lungs.

It is designed to be 5,000 times smaller than blood cells and efficiently transport oxygen through the body for a period of nine hours before being processed by the liver. The drug helps in supplying oxygen to the vital organs and enables the patient to recover and survive.

Other

T89 (Tasly Pharmaceuticals, Inc.)

Tasly Pharmaceuticals has conducted an open-label, randomized clinical study to investigate the effect of T89 on improving oxygen saturation and clinical symptoms in patients with Coronavirus Disease 2019 (COVID-19).

Xiyanpinginjection (Jiangxi Qingfeng Pharmaceutical Co. Ltd)

Xiyanping is primarily composed of 9-dehydro-17-hydro-andrographolide and sodium 9-dehydro-17-hydro-andrographolide-19-yl sulfate. Xiyanping is an anti-inflammatory and antiviral preparation developed and licensed for use in China. It is a semi-synthetic injectable product derived from the active component of the plant Andrographispaniculata, which is used in Traditional Chinese medicine. Qingfeng Pharmaceutical is conducting a randomized, open-label trial to evaluate the safety and efficacy of Xiyanping injection in patients with 2019-nCoV pneumonia.