FibroGen has started enrolment for a Phase II clinical trial of pamrevlumab for the treatment of patients hospitalised due to Covid-19 in the US.
Pamrevlumab is an antibody designed to block the activity of connective tissue growth factor (CTGF), which is involved in fibrotic and proliferative diseases with persistent and excessive scarring that can cause organ dysfunction and failure.
Set to recruit about 130 patients at various sites in the US, the Phase II study will assess the safety and efficacy of pamrevlumab. Participants will be given the drug or standard of care.
The primary objective is the impact of pamrevlumab on blood oxygenation, while the primary efficacy assessment is the proportion of patients not requiring mechanical ventilation and/or extracorporeal membrane oxygenation and remaining alive at day 28.
This trial’s primary aim is to monitor the drug’s effect on patient time to and on ventilatory support, along with its ability to mitigate mortality and fibrotic sequelae in the lungs.
FibroGen Clinical Development, Drug Safety and Pharmacovigilance senior vice-president Elias Kouchakji said: “The majority of patients with severe forms of Covid-19 have bilateral interstitial pneumonia, causing reduction in oxygenation and severe respiratory failure.
“The administration of pamrevlumab, a first-in-class anti-connective growth factor monoclonal antibody, could protect the lung from the immediate consequences of the infection presented as acute respiratory distress syndrome.”
The company is planning to conduct a second trial in the US to evaluate the longer term efficacy and safety of the drug in patients who have recovered or are recovering from Covid-19 with evidence of interstitial lung disease.
Earlier this month, FibroGen started patient enrolment for a Phase II/III trial of pamrevlumab for the treatment of severe Covid-19 infection in Italy. This trial is designed for approximately 68 patients.