The Food and Drug Administration (FDA) has granted Fast Track designation to RLF-100 (Aviptadil; NeuroRx and Relief Therapeutics) for the treatment of acute lung injury/acute respiratory distress syndrome associated with coronavirus disease 2019 (COVID-19).
RLF-100 is a synthetic form of human vasoactive intestinal peptide (VIP). The investigational treatment is expected to reduce inflammation in the lungs and protect alveolar type II cells from injury associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
The Company is assessing the effects of RLF-100 in a phase 2/3 clinical trial. The multicenter, randomized, placebo-controlled trial will aim to enroll approximately 144 patients with critical COVID-19 and respiratory failure. Patients will be randomized to receive either RLF-100 intravenously or placebo, in addition to standard of care. The primary end points will be improvement in mortality and blood oxygenation.
The trial will be conducted at major medical centers including the University of Miami, Houston Methodist Hospital, University of California-Irvine, the NYU Langone Medical Center, and the Rambam Healthcare Campus (Haifa, Israel). In addition, the FDA has requested the Company submit a publicly-available expanded access policy, which would allow patients not participating in the ongoing trials to gain access to RLF-100.
“This milestone demonstrates the effectiveness of the FDA CoronaVirus Treatment Acceleration Program and the FDA’s achievement in rising up to address the most severe public health crisis of our lifetime,” said former FDA Chief Counsel, Daniel Troy, a member of the Company’s board of directors.