NeuroRx and Relief Therapeutics have secured fast track designation from the US Food and Drug Administration (FDA) to evaluate RLF-100 (Aviptadil) to treat acute lung injury/acute respiratory distress syndrome associated with Covid-19.
RLF-100 is a synthetic form of human vasoactive intestinal peptide (VIP), which minimises inflammation in the lungs and protects the alveolar type II cells that are considered to provide an entry route for the SARS-CoV-2 to reach the lungs.
RLF-100 will be assessed in phase 2/3 clinical trials at major medical centres such as the University of Miami, Houston Methodist Hospital, University of California-Irvine, the NYU Langone Medical Centre, and the Rambam Healthcare Campus in Haifa of Israel.
The patients with critical Covid-19 and respiratory failure will be recruited in the multicentre clinical trial with an aim of decreasing mortality and enhancing blood oxygenation in this condition by protecting alveolar type II cells from the SARS-CoV-2 virus.
RLF-100 is a patented formulation of VIP that was designed based on Dr. Said’s original work. It was secured approval for human trials by the FDA in 2001 and the European Medicines Agency in 2005.
The VIP, which is mainly concentrated in the lung, is said to provide protection against different lung injuries. It received orphan drug designation in 2001 from the FDA to treat acute respiratory distress syndrome, while in 2005 for treatment of pulmonary arterial hypertension.
In 2008, the VIP secured orphan drug designation from the European Medicines Agency to treat acute lung injury, while in 2007 for the treatment of sarcoidosis.
NeuroRx CEO and chairman professor Jonathan Javitt said: “We at NeuroRx are enormously appreciative of the FDA’s commitment to accelerating the development of any potential treatment for Covid-19. We hope to live up to the trust that has been placed in us by bringing a life-saving treatment to patients.”
Recently, Eli Lilly has commenced a phase 3 clinical trial with baricitinib, marketed as Olumiant, for hospitalised Covid-19 patients.
The phase 3 randomised, double-blind and placebo-controlled study will assess the efficacy and safety of baricitinib, an oral JAK1/JAK2 inhibitor licenced from Incyte, in hospitalised adults with Covid-19.