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FibroGen Initiates Phase II/III Study in Severe Coronavirus

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FibroGen Inc. (FGEN - Free Report) announced that it has initiated a phase II/III open-label, study (BOREA) in Italy investigating the efficacy and safety of pamrevlumab in patients with severe COVID-19 infection. The study will include 68 hospitalized patients who will receive either pamrevlumab or standard of care. The primary objective of this study is to assess the effect of pamrevlumab on blood oxygenation in patients with COVID-19 infection.

Pamrevlumab is a first-in-class antibody developed by FibroGen that inhibits the activity of connective tissue growth factor (CTGF), a common factor in fibrotic and proliferative disorders.  CTGF may promote vascular leakage and lead to pulmonary edema or excess fluid in the lungs. Administration of pamrevlumab, an anti-CTGF monoclonal antibody, may reverse this edema, and thus improve oxygenation in patients with COVID-19-induced pneumonia.

This study will evaluate pamrevlumab’s effect on patient time to and on ventilatory support, and its potential to reduce mortality and fibrotic sequelae in the lung, a complication in COVID-19 patient

Shares of FibroGen have lost 21.7% year to date compared with the industry’s decline of 4%.

Further, FibroGen announced that it will initiate two additional phase II studies investigating the efficacy and safety of pamrevlumab versus standard of care in patients with severe COVID-19 infection in the United States. The Investigational New Drug (IND) application for the first study is approved by the FDA, and the study will assess the efficacy and safety of pamrevlumab in approximately 130 patients hospitalized with COVID-19 in the acute setting.

The second planned U.S. study, in discussions with the FDA, is expected to assess the longer term efficacy and safety of pamrevlumab in patients who recovered or are recovering from COVID-19 infection with evidence of interstitial lung disease.    

The entire world is hoping for a rapid development of a treatment/antibody to treat COVID-19 or a vaccine to prevent the disease.

Meanwhile, several marketed drugs like Sanofi,/Regeneron’s IL-6 inhibitor Kevzara, Roche’s (RHHBY - Free Report) IL-6 inhibitor, Actemra, Incyte/Novarts’ JAK1/JAK2 inhibitor, Jakafi, AstraZeneca’s (AZN - Free Report) BTK inhibitor, Calquence, Amgen’s (AMGN - Free Report) PDE4 inhibitor, Otezla  among others are being evaluated to treat respiratory complications associated with COVID-19, which is also the need of the hour.

 

Zacks Rank

FibroGen currently has 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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