FibroGen has started patient enrolment for a Phase II/III clinical trial of pamrevlumab for the treatment of severe Covid-19 infection in Italy.
Pamrevlumab is an antibody designed to block the activity of connective tissue growth factor (CTGF), which is associated with fibrotic and proliferative diseases with persistent and excessive scarring that can cause organ dysfunction and failure.
The drug is in Phase III development to treat idiopathic pulmonary fibrosis (IPF) and locally advanced unresectable pancreatic cancer (LAPC), and in Phase II development for Duchenne muscular dystrophy (DMD) and Covid-19.
FibroGen Clinical Development, Drug Safety, and Pharmacovigilance senior vice-president Elias Kouchakji said: “Connective tissue growth factor (CTGF) may promote vascular leakage and lead to pulmonary edema.
“Administration of pamrevlumab, an anti-CTGF monoclonal antibody, may reverse this edema, and thus improve oxygenation in patients with Covid-19-induced pneumonia.”
The open-label, randomised, parallel-arm Phase II/III BOREA trial will assess the safety and efficacy of the drug in about 68 patients. Participants will be given pamrevlumab or standard of care.
The primary objective of the trial is the effect of the drug on blood oxygenation in patients.
The study will evaluate the drug’s impact on patient time to and on ventilatory support, along with its potential to decrease mortality and fibrotic sequelae in the lung.
FibroGen also announced plans to launch two separate randomised, double-blind, placebo-controlled Phase II studies of the drug in patients with severe Covid-19 in the US.
The US Food and Drug Administration (FDA) approved the first trial to evaluate the safety and efficacy of pamrevlumab in about 130 hospitalised patients in the acute setting.
Meanwhile, the second trial is under discussion with the FDA and is intended to assess the longer term safety and efficacy of the drug in patients who recovered or are recovering from Covid-19 with evidence of interstitial lung disease.