RELIEF THERAPEUTICS Holding AG, a biopharmaceutical company with its lead compound RLF-100TM (aviptadil) in advanced clinical development to treat COVID-19-induced lung injury, and AdVita Lifescience GmbH , a Germany-based, privately held pharmaceutical company developing effective products and strategies to improve the treatment and diagnosis of rare lung diseases, announced that the first patient is expected to be enrolled next week in a phase 2 trial evaluating the inhaled formulation of RLF-100 for the prevention of COVID-19-related acute respiratory distress syndrome (“ARDS”).
The study, “Inhaled Aviptadil for the Prevention of COVID-19 Related ARDS” (NCT 04536350), is a randomized, double-blind, placebo-controlled phase 2 trial being conducted at several clinical sites in Switzerland. The trial is expected to enroll 80 patients, who will receive either RLF-100 together with standard of care or placebo plus standard of care. The primary endpoint is the time (in days) from hospitalization to clinical improvement, up to day 28. Clinical improvement shall be defined as either alive hospital discharge or a decrease of two or more points on the WHO-recommended nine-point ordinal scale of clinical status (WHO, 2020). The Principal Investigator of the trial is Prof. Dr. Joerg D. Leuppi, M.D., Ph.D., Professor for Internal Medicine, University of Basel, Head of the University Clinic of Medicine Cantonal Hospital Baselland, Liestal, Switzerland. AdVita is providing all relevant documentation, financial support with the aid of Relief, and study drug for the trial. It is estimated that the study will take approximately 6-12 months to complete, depending on the progression of the ongoing COVID-19 pandemic.