March 19 COVID-19 Product Development Roundup: Actemra trial begins; plus CytoDyn's leronlimab, a post-exposure prophylaxis trial, and Abbott's EUA
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The start of a placebo-controlled Phase III trial of Genentech's Actemra to treat hospitalized patients with COVID-19 was one of several signs of progress Thursday among programs to treat or diagnose the disease.
Along with competing IL-6 inhibitor Kevzara sarilumab from Sanofi (Euronext:SAN; NASDAQ:SNY) and Regeneron Pharmaceuticals Inc. (NASDAQ:REGN), Actemra tocilizumab is being studied to evaluate its effects on later-stage patients with severe disease.
While antiviral drugs may be used to treat patients in the earlier stages of SARS-CoV-2 infection, there's a strong case to be made for anti-inflammatory agents such as Actemra tocilizumab after respiratory function deteriorates (see "Slotting Anti-Inflammatories Into Treatment").
Genentech said Thursday it had begun a global Phase III trial of Actemra in hospitalized patients who had developed pneumonia related to COVID-19. By early next month, the unit of Roche (SIX:ROG; OTCQX:RHHBY) aims to begin enrolling up to 340 patients, with primary and secondary endpoints evaluating clinical status, mortality, mechanical ventilation and intensive care unit (ICU) variables. Patients will receive standard of care plus Actemra or placebo.
HHS's Biomedical Advanced Research and Development Authority (BARDA) is backing the trial.
China's National Health Commission included the drug in a treatment plan for COVID-19 issued March 3.
Sanofi and Regeneron announced on Monday the start of their Phase II/III trial of competing IL-6 inhibitor Kevzara sarilumab to treat severe COVID-19. Beginning in New York, the 400-patient trial's placebo-controlled first part will include up to 16 U.S. sites before expanding in a larger second part.
FDA has approved both Actemra and Kevzara to treat rheumatoid arthritis.
Elsewhere, other organizations reported updates to their COVID-19 programs.
CytoDyn Inc. (OTCQB:CYDY) said two patients in greater New York City have received the company's CCR5 antagonist leronlimab under an emergency IND granted by FDA. The company has submitted a Phase II trial protocol to the agency. CytoDyn believes the mAb can block pro-inflammatory cytokines and thus prevent cytokine storms associated with COVID-19 infection.
The University of Minnesota is sponsoring a Phase II/III trial of antimalarial drug hydroxychloroquine as prophylaxis following exposure to SARS-CoV-2. The study will enroll about 1,500 healthcare workers or persons with whom they have had household contact to receive the agent or placebo. The study will be conducted remotely, with the therapy shipped to participants' homes and data collected online.
FDA granted an Emergency Use Authorization to the RealTime SARS-CoV-2 assay from the Abbott Molecular division of Abbott Laboratories (NYSE:ABT). It is one of a handful that have received EUAs since Roche received one late last week (see "U.S. Moves to Unlock Test Capacity").
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CCR5 (CD195) - CC chemokine receptor 5
IL-6 - Interleukin-6