Relief Therapeutics and its U.S. partner, NeuroRx announced NeuroRx has completed final manufacturing of investigational drug RLF-100 for Phase 2b/3 clinical trial to assess intravenous RLF-100 as a treatment for Acute Respiratory Distress Syndrome (ARDS) in COVID-19 patients on mechanical ventilation.
Bachem Americas and MedisourceRx respectively, manufactured RLF-100 drug substance and drug product under the supervision of NeuroRx scientists Richard Siegel, Ph.D., and Robert Besthof MIM, who previously held leadership positions at Johnson & Johnson and Pfizer prior to joining NeuroRx. Manufacture and release of investigational product was completed within 60 days of FDA’s approval to proceed with the clinical trial.
Researchers at the University of Miami have begun enrollment of patients with COVID-19 and enrollment at Thomas Jefferson University, and University of California – Irvine is expected to commence shortly. Additional sites at NYU Langone and six other locations across the U.S. will begin enrolling patients by June 2020. RLF-100 is a patented formulation of Aviptadil, a synthetic human vasoactive intestinal polypeptide (VIP) that targets alveolar type 2 cells in the lungs attacked by SARS-CoV-2 virus. VIP is known from numerous animal models of lung injury and lung disease to inhibit inflammatory cytokines and to protect pulmonary epithelial cells that line the air sacs (alveolae) of the lungs.
“Tragically, survival of patients with COVID-19 who progress to Acute Respiratory Distress is dismal. There is an urgent need for a treatment approach that goes right into the heart of the matter – the alveolar type 2 cells which are vulnerable entry points and hosts for the SARS-CoV-2 virus,” said Jonathan Javitt, M.D., CEO of NeuroRx. “In previous human studies, RLF-100 was seen to decrease inflammatory cytokines. In laboratory studies, it is known to increase the production of surfactants by type 2 cells needed to maintain oxygen exchange in the lungs and could potentially protect type 2 cells from cell death in COVID-19.”
RLF-100 is a synthetic form of VIP, which is the body’s defense against many lung injuries ranging from infectious disease to smoke inhalation. VIP is known to preferentially bind to the precious type 2 cells in the lungs that are directly attacked by the coronavirus. While there are many drugs being tested in the clinic today, we are not aware of another drug candidate that specifically targets the cells that are lost in COVID-19 lung injury.
Relief Therapeutics and NeuroRx are engaging clinical trials authorities in the European Union, the United Kingdom, Russia, and Australia in order to broaden the clinical study and increase access to RLF-100.