The effort to establish bemcentinib as a COVID-19 drug continues. Eleven months after failing a phase 2 trial, BerGenBio has shared data from a second, smaller trial that linked the drug to significant changes.
BerGenBio’s hopes of establishing its AXL inhibitor bemcentinib as a treatment for patients hospitalized with COVID-19 took a hit 11 months ago when it revealed its BGBC020 phase 2 clinical trial had missed its primary goal. Two months later, the Norwegian biotech arrived at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) armed with data from BGBC020 and a second study, BGBC019.
With the two trials using the same design, BerGenBio pooled the 115 subjects from BGBC020 with the 62 patients in BGBC019 in the ECCMID analysis. Now, BerGenBio has shared data on 61 patients treated as part of BGBC019, a subprotocol of a U.K. platform trial, separately for the first time.
Of the 29 patients who received bemcentinib plus standard of care, 26 experienced a clinical response by day 29, resulting in a 90% response rate. The trial defined clinical response as a two-point improvement on a WHO scale or discharge from hospital. Patients on bemcentinib had a response after a median of 7.0 days.
Twenty two of the 32 patients who received standard of care alone had a clinical response. The response rate therefore came in at 69% and the median time to response was 9.5 days. BerGenBio said the result was statistically significant, although it previously said the scale “is subject to a broad range of subjective factors” and “may not directly measure the individual patient's health, or the benefit from bemcentinib.”
Almost all the participants received dexamethasone or an equivalent steroid in their standard of care. Almost one-fifth, 18%, received Roche’s Actemra. Use of Gilead’s Veklury differed between the two arms, with 53% of patients in the control group getting the therapy versus 21% of subjects in the bemcentinib cohort.
BerGenBio also presented a look at secondary endpoints, stating that bemcentinib bettered the control in terms of the avoidance of any deterioration by a one point or more increase in the WHO score and ventilator-free survival over 29 days. At day 29, 97% of people in the bemcentinib arm were alive, versus 81% in the control group.
Investors were underwhelmed by the data, sending shares in BerGenBio down 2% to around NOK 18 ($2.5) in Oslo. The question of whether BerGenBio’s continued enthusiasm for bemcentinib in COVID-19 is warranted may be answered more conclusively by the EU-SolidAct trial, a phase 2/3 platform trial that is set to study the drug candidate in up to 500 hospitalized COVID-19 patients.