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New trial data about BerGenBio’s bemcentinib in COVID-19 patients

Coronavirus Credit NIAID

The company has announced data from a Phase II trial assessing Bemcentinib in hospitalized COVID-19 patients.

The trial shows that Bemcentinib has the potential to increase the rate of ventilator free survival in more than 50% of hospitalized COVID-19 patients, states the company in a press release. The trial was conducted from October 2020 across multiple sites in South Africa and India, with 115 patients enrolled at the end of March 2021.

“The trial shows that Bemcentinib has the potential to increase the rate of ventilator free survival in more than 50% of hospitalized COVID-19 patients.”

The patients were randomized to receive standard of care (SOC) only, or bemcentinib with SOC; 76% of patients received steroids and 51% also received remdesivir as part of their therapy. Patients were closely evaluated through 29 days following admission to assess efficacy endpoints, and to 90 days after randomization to determine longer outcomes.

Ventilator Free Survival was observed in 90% in bemcentinib treated patients vs 72% in SOC treated patients, in a subgroup of patients with increased disease severity. The survival benefit was numerically greater in bemcentinib treated patients and bemcentinib’s anti-viral mechanism of action was supported by analysis. Bemcentinib was well tolerated throughout the trial.

The next steps

Full scientific analysis of the trial, BGBC020, will be combined with the ACCORD2 data set in a meta-analysis for presentation at a scientific conference and publication in a peer-reviewed journal.

The totality of data clearly informs a benefit from bemcentinib in treating a substantial subset of hospitalized COVID-19 patients. This will support ongoing engagement with regulatory agencies, Government partners and industry, states the company.

“Through diligent analysis of all the data collected, the totality of which supports the unique mechanism of action of bemcentinib in potentially treating hospitalized COVID-19 patients, we now have a clear clinical position for bemcentinib in this disease.”

“The potential of bemcentinib to increase the rate of ventilator free survival in more than 50% of hospitalized COVID-19 patients is very encouraging. This represents a meaningful outcome for both patients and healthcare systems and is of potential great value. This was an exploratory real world study completed in several global geographies, with differing demographics and ethnicities and evolving standards of care. Through diligent analysis of all the data collected, the totality of which supports the unique mechanism of action of bemcentinib in potentially treating hospitalized COVID-19 patients, we now have a clear clinical position for bemcentinib in this disease. We will continue our discussion of these results with the regulators, industry and Government partners to determine next steps,” says Richard Godfrey, Chief Executive Officer of BerGenBio.

Richard Godfrey

Richard Godfrey, CEO, BerGenBio

Featured image: Coronavirus. Credit: NIAID