Roche Holdings RHHBY announced that it is working with the FDA to initiate a late-stage study to evaluate the safety and efficacy of rheumatoid arthritis drug Actemra/RoActemra (tocilizumab) plus standard of care in hospitalized adult patients with severe COVID-19 pneumonia compared to placebo plus standard of care.
The randomized, double-blind, placebo-controlled phase III study will be conducted 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).
Per Roche, this is the first global study of Actemra/RoActemra in this setting. The study is expected to begin enrolling, with a target of approximately 330 patients globally, including the United States.
The primary and secondary endpoints include clinical status, mortality, mechanical ventilation and intensive care unit (ICU) variables. Patients will be followed for 60 days post-randomization, and an interim analysis will be conducted to look for early evidence of efficacy.
Meanwhile, several independent clinical ongoing studies exploring the efficacy and safety of Actemra/RoActemra for the treatment of patients with COVID-19 pneumonia. The drug has been included in the 7th updated diagnosis and treatment plan for COVID-19 issued by China’s National Health Commission (NHC) on Mar 3, 2020.
Apart from RA, Actemra is approved globally for polyarticular juvenile idiopathic arthritis (pJIA) and in the United States and Europe for systemic juvenile idiopathic arthritis (sJIA) in children two years of age and older.
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.
Earlier, Roche received FDA Emergency Use Authorisation for the cobas SARS-CoV-2 Test to detect the novel virus that causes the COVID-19 disease.
Roche’s stock has gained 10.6% in the past year against the industry’s 9.8% decline.
Quite a few pharma and biotech companies are striving hard to come up with treatments and vaccines to combat this virus.
Regeneron REGN and partner Sanofi SNY have also announced a program to evaluate their RA drug, Kevzara, to treat patients hospitalized with severe infection due to COVID-19. Regeneron also has identified antibodies, which can possibly treat COVID-19. Earlier in the week, Moderna, Inc., MRNA dosed the first participant in the phase I study of mRNA vaccine (mRNA-1273) against the SARS-CoV-2.
Roche currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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