Given the widespread outbreak of COVID-19, many pharma/biotech companies are joining the race for developing treatments for the same.
Per the recent results published in The New England Journal of Medicine, HIV drug, Kaletra, failed to show any benefit over standard care in adult patients with severe COVID-19 in China. The study enrolled 199 patients, with 99 receiving Kaletra and 100 receiving standard of care. The primary endpoint was the time to clinical improvement, defined as the time from randomization to either an improvement of two points on a seven-category ordinal scale or discharge from the hospital. The results come as a disappointment, given the urgent need for treating infected patients. Currently, there are no FDA-approved treatments for the severe illness caused by SARS-CoV-2. Given the alarming levels of spread and severity, some approved drugs or pipeline candidates are being tested to see if they are effective in treating the infected patients.
We note that efforts to develop a vaccine to combat this deadly virus have accelerated in the last couple of weeks. Earlier in the week, Moderna, Inc., (
MRNA - Free Report) dosed the first participant in the phase I study of mRNA vaccine (mRNA-1273) against SARS-CoV-2. Quite a few others like Novavax, Inc. and Inovio Pharmaceuticals, Inc. are developing vaccines to address the disease. Big pharmas like Johnson & Johnson and GlaxoSmithKline are making efforts too to develop a vaccine. VIDEO
While the successful development of a vaccine will prevent infection and stop the virus from spreading further, there is a greater need for drugs/treatments for infected patients. Also, the development of a vaccine will require a longer timeframe. Hence, we take a look at companies, which are working on drugs/treatments to combat this disease as the number of infected patients is growing with each passing day.
The company pioneering the race is
Gilead Sciences, Inc. ( GILD - Free Report) , which has initiated two phase III studies to evaluate the safety and efficacy of remdesivir in adults diagnosed with COVID-19. These randomized, open-label, multicenter studies will enroll approximately 1,000 patients at medical centers primarily across Asian countries. The studies will assess two dosing durations of the candidate, administered intravenously. Reportedly, remdesivir is already being used in the United States for the treatment of the disease under federal rules that allow the use of unapproved drugs on compassionate grounds. The candidate was previously under testing for Ebola virus. As the candidate has shown promising results in the infected patients, investors are banking on Gilead for being the first company to come up with a treatment for this deadly disease. Regeneron Pharmaceuticals ( REGN - Free Report) too has identified antibodies, which can possibly treat COVID-19. The company has now isolated hundreds of virus-neutralizing, fully-human antibodies from its VelocImmune mice, which have been genetically-modified to have a human immune system. The company has also isolated antibodies from humans who have recovered from COVID-19 to maximize the pool of potent antibodies. The company plans to select the top two antibodies for a 'cocktail' treatment based on potency and binding ability to the SARS-CoV-2 spike protein as well as other desirable qualities. Earlier, Regeneron and partner Sanofi ( SNY - Free Report) announced a program to evaluate their rheumatoid arthritis (RA) drug, Kevzara, to treat patients hospitalized with severe infection due to COVID-19.
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Swiss pharma giant
Roche ( RHHBY - Free Report) is working with the FDA to initiate a phase III study in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Health and Human Services Office of the Assistant Secretary for Preparedness and Response (ASPR), to evaluate the safety and efficacy of RA drug, Actemra (tocilizumab), plus standard of care in hospitalized adult patients infected with COVID-19 compared with placebo plus standard of care.
Clinical-stage biotechnology company,
Enanta Pharmaceuticals, Inc. ( ENTA - Free Report) , has also initiated a program to discover direct-acting antiviral drug candidates for the treatment of patients infected with the novel coronavirus. It is testing compounds from its antiviral compound library for potential activity against COVID-19. Eli Lilly ( LLY - Free Report) has collaborated with AbCellera to co-develop antibody products for the treatment and prevention of COVID-19. Both companies will select from 500+ unique antibodies isolated from one of the first patients who recovered from COVID-19 in the United States to create antibody therapeutics for the treatment and prevention of COVID-19.
While the drugs and vaccines will need some time to be tested and a cure is not imminent, investors will keep an eye on these companies as the pandemic is not likely to die out soon. A positive outcome from any of the ongoing studies will be a significant boost for the respective company.
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