Kurs & Likviditet
Beskrivning
Land | Norge |
---|---|
Lista | OB Match |
Sektor | Hälsovård |
Industri | Bioteknik |
2021-07-12 14:12:15
· Survival 96.6% vs 91.2%
· Significantly reduced likelihood (69%) of progression to ventilation in
higher severity cohort
· Significantly increased likelihood (88%) of shorter time to recovery or
discharge in higher severity cohort
· Clinical evidence of anti-viral mechanism of action
· Preclinical analysis highlights bemcentinib's potential against COVID-19
variants
Bergen, Norway, 12 July 2021?- BerGenBio ASA (OSE: BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
severe unmet medical need, has presented a combined analysis of data from two
Phase II studies investigating bemcentinib in hospitalised COVID-19 patients at
the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID).
Data was presented from the UKRI PhaseII ACCORD2 platform study, sponsored by
University Hospital Southampton, UK and BGBC020, BerGenBio's open-label Phase II
study conducted in South Africa and India. In total, 179 eligible patients were
enrolled across both studies between May 2020 and March 2021, randomly allocated
on an open-label basis to treatment with bemcentinib in addition to standard of
care (SoC) compared to SoC alone. The two studies shared an identical design,
and combined data presented today showed encouraging survival benefit of 96.5%
vs 91.2%, with fewer deaths within 29 days of enrolment in bemcentinib treated
patients (1 of 30 and 2 of 58, 3.4%) versus SoC (5 of 34 and 3 of 57, 8.8%),
respectively.
As previously reported for BGBC020, a post-hoc analysis identified a sub-group
of patients with higher disease severity on enrolment within 24 hours of
admission to hospital in whom evidence of a treatment benefit with bemcentinib
was observed. Patients in the subgroup were receiving oxygen (Grade 4) or non
-invasive ventilation (Grade 5) and recorded serum levels of the inflammatory
marker C-Reactive Protein (CRP) greater than 30mg/L. This subgroup represents
more than 60% of the patients in the combined study population, and the
previously reported treatment benefit in this group of patients in India and
South Africa is reproduced in analysis of the patients studied in the UK.
Across both studies, evaluation of the primary endpoint of time to recovery or
discharge, in this defined patient subgroup with higher baseline disease
severity, showed there was a statistically significant greater likelihood of
faster time to recovery or hospital discharge with bemcentinib added to SoC,
compared to SoC alone