RE: R and d day16 Jun 2020 08:12
Traumakine
Traumakine, Faron’s investigational intravenous (IV) interferon (IFN) beta-1a, is currently under development for the treatment of patients with Acute Respiratory Distress Syndrome (ARDS) and is being used in two global, adaptive trials investigating potential COVID-19 treatments – REMAP-CAP, the Randomized, Embedded, Multifactorial Adaptive Platform rial for Community-Acquired Pneumonia, and the WHO Solidarity trial.
Today the Company announces that a third trial will investigate the potential of Faron’s IV IFN beta-1a to treat COVID-19. HIBISCUS (Human Interferon Beta In Severe CoronavirUS), will be an investigator initiated study at Harvard Medical School’s Beth Israel Deaconess Medical Center (BIDMC), focused on ICU patients with ARDS caused by viral infection (e.g. COVID-19, influenza). The phase II/III pivotal, randomized, placebo controlled study aims to recruit 350 patients with 1:1 randomization who will be followed for ventilation free dats (VFD) and mortality over the 28 day period post first dosing. No corticosteroid use will be accepted in the study which is expected to enroll patients over 6-8 months throughout the US with many significant hospitals participating. Commencement of the trial remains subject to finalisation of funding arrangements and regulatory approval. Further announcements will be made in due course.
Dr. Markku Jalkanen, Faron's CEO, said: “We are pleased today to be reporting the continued progress of our two development programmes. Confirming the generic name, bexmarilimab, for our lead immunotherapy is an important milestone for this programme which is rapidly advancing and has shown exciting clinical activity. The positive data seen so far for bexmarilimab gives us the confidence to pursue ambitious future clinical expansion plans for this potential therapy.
“The scientific community is currently focused on discovering new therapeutics to treat COVID-19 and we are very pleased to be supporting these efforts, now with three trials investigating the potential of Traumakine in severely ill patients. We continue to believe in the potential of Traumakine as a future treatment for ARDS and one that could have significant impact on the intensive-care burden from COVID-19. We look forward to providing updates on both development programmes as they progress.”