BerGenBio fails COVID-19 trial, makes post hoc case for program

BerGenBio
BerGenBio saw a clearer separation between its control and bemcentinib in 62 patients who were on oxygen at baseline. (BerGenBio)

A phase 2 clinical trial of BerGenBio’s bemcentinib in hospitalized COVID-19 patients has missed its primary endpoint. The AXL inhibitor failed to accelerate time to sustained clinical improvement over standard of care, but BerGenBio identified a subgroup analysis of a secondary endpoint as a reason to continue development.

BerGenBio set out to show that adding bemcentinib to standard of care reduces the time it takes for patients to be ready for discharge or have a two-point improvement on a World Health Organization (WHO) scale. With a p-value of 0.5, bemcentinib failed by that yardstick. BerGenBio made the results look a little better in a post hoc analysis of a subset of patients who needed oxygen and had elevated levels of an inflammatory biomarker, although the result still fell short of statistical significance. 

BerGenBio pinned the failure on its choice of primary endpoint, saying the measure is “subject to a broad range of subjective factors” and as such “may not directly measure the individual patient’s health, or the benefit from bemcentinib.” 

The Norwegian biotech would rather focus on time to deterioration by one or more grade on the WHO scale. Across the entire 115-patient study, bemcentinib failed to improve on standard of care in terms of time to deterioration. However, BerGenBio saw a clearer separation between its control and bemcentinib in 62 patients who were on oxygen at baseline, leading the company to claim its drug may improve ventilator-free survival. The p-value for the subgroup analysis was 0.06.

That is the lowest p-value shared by BerGenBio in its presentation of the data. BerGenBio found a numerical difference between the two subgroup arms in survival, but it fell short of significance, with the p-value coming in at 0.13. BerGenBio is now planning the next steps.

“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,” BerGenBio CEO Richard Godfrey said in a statement.