BerGenBio ASA announced that a complete data analysis of a randomized phase II study of bemcentinib in combination with standard of care (SoC) therapy, ACCORD2 (BGBIL019), in hospitalized COVID-19 patients confirms that the primary efficacy endpoint was met. At the July 2021 European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) meeting, the Company previously presented preliminary data from the ACCORD2 study in combination with a second COVID-19 study (BGBC020) showing evidence of therapeutic benefit on meaningful clinical endpoints in a total of 177 patients. Today's announcement is the first time complete ACCORD2 data in a total of 61 treated patients has been separately reported.

Overall, 90% of patients treated with bemcentinib + SoC (26 of 29) experienced a clinical response by day 29 (median 7.0 days), as defined by either a two-point improvement in World Health Organization (WHO) category from baseline score, or discharge from hospital, whichever arose sooner. This compared to 69% (22 of 32 patients) with a clinical response to SoC treatment alone (median 9.5 days), showing statistical significance. The data was generated under a sub-protocol of the platform ACCORD2 study (ACCORD2; EudraCT 2020-001736-95 - BGBIL019), a multi-center phase II randomized study designed to assess the efficacy and safety of candidate agents as add-on therapies to SoC for the treatment of COVID-19 in hospitalized patients.

Overall, 98% of patients received dexamethasone or an equivalent steroid in their SoC, and 18% received immunomodulatory treatment with tocilizumab. The antiviral remdesivir was used in 53% of those randomized to SoC alone, and in 21% of patients treated with bemcentinib. In addition, key secondary endpoints saw statistically significant improvements for the bemcentinib + SoC arm compared to SoC alone, including avoidance of any deterioration by =1-point increase in WHO score (including death) and ventilator-free survival over 29 days.

At day 29, 97% of bemcentinib + SoC treated patients were alive compared to 81% of SoC-alone. Bemcentinib treatment was well tolerated in this patient population, with no clinically relevant safety signals in comparison to standard of care treatment. These latest results underline bemcentinib's potential in COVID-19 and other severe respiratory infections.

As previously announced, bemcentinib will be studied in the EU-SolidAct trial in up to 500 hospitalized COVID-19 patients.