Relief inks partnership for commercialisation of Covid-19 treatment

RELIEF THERAPEUTICS Holding SA and NeuroRx, Inc. have agreed that NeuroRx will lead commercialization in the United States, Canada, and Israel, while Relief will lead commercialization in Europe and the rest of the world. Profits from sales will be allocated to Relief and NeuroRx on a 50/50 basis in the U.S., Canada and Israel, 85/15 (in favor of Relief) in Europe, and 80/20 (in favor of Relief) in all other territories.

The two companies have now taken steps to increase manufacturing of the aviptadil drug substance and are in the final stages of contracting with a fill/finish manufacturer, along with a national distribution partner. By January 2021, Relief and NeuroRx expect to have manufacturing, distribution and logistics capacity in place to deliver sufficient drug quantities to treat 150,000 patients per month with RLF-100. The companies continue to anticipate reporting top-line data from the ongoing randomized, double-blinded, placebo-controlled trial of intravenously-administered RLF-100 before the end of 2020. The trial of inhalation-administered RLF-100 is slated to begin enrollment within the coming weeks.

RLF-100 (Aviptadil) is a formulation of Vasoactive Intestinal Polypeptide (VIP) that was developed based on Sami Said's original work at Stony Brook University, for which Stony Brook was awarded an FDA Orphan Drug Designation in 2001. VIP is known to be highly concentrated in the lungs, where it inhibits coronavirus replication, blocks the formation of inflammatory cytokines, prevents cell death, and upregulates the production of surfactant.

FDA has now granted IND authorization for intravenous and inhaled delivery of RLF-100 for the treatment of COVID-19 and awarded Fast Track designation. Since July 2020, severe COVID-19 patients have been treated with RLF-100 under U.S. FDA Emergency Use Investigational New Drug (IND) authorization and Expanded Access Protocol authorization for the treatment of respiratory failure in COVID-19.