Relief Therapeutics and AdVita Lifescience are set to enrol the first patient in a Phase II trial of an inhaled formulation of the former’s lead compound, RLF-100 (aviptadil), for preventing Covid-19-related acute respiratory distress syndrome (ARDS).
A synthetic form of a vasoactive intestinal peptide, aviptadil is being developed by NeuroRx as Zyesami in partnership with Relief Therapeutics.
Named ‘Inhaled Aviptadil for the Prevention of COVID-19 Related ARDS’, the randomised, double-blind, placebo-controlled trial will be carried out at various clinical sites in Switzerland.
It plans to enrol a total of 80 subjects with Covid-19. They will be given either RLF-100 or placebo, along with standard of care.
The time (days) from hospitalisation to clinical improvement, for up to day 28, will form the trial’s primary endpoint.
Relief Therapeutics chief medical officer Gilles Della Corte said: “This study will be helpful in building the clinical database for inhaled RLF-100 in preventing Covid-19 patients from developing acute respiratory distress syndrome.
“The results will provide an important insight as we advance the development of this product candidate in Europe.”
In the second half of this year, the company intends to launch a Phase II dose-finding study of inhaled RLF-100 for treating pulmonary sarcoidosis in Europe.
In another development, the US National Institute of health (NIH) has begun subject enrolment in a new Phase III ACTIV-3 Critical Care trial of Zyesami and remdesivir (Veklury) for treating hospitalised Covid-19 patients with ARDS.
Zyesami is a formulation of aviptadil acetate, while remdesivir is an antiviral developed by Gilead Sciences.
The randomised, blinded, placebo-controlled clinical trial will analyse Zyesami and remdesivir (alone and in combination) for their safety and efficacy in these patients.
In the initial stage, a small group of 40 subjects will be enrolled at sites in the US. The trial will enrol a larger cohort of subjects at more US and global sites on finding no safety issues.
The NIH earlier commenced subject enrolment in Phase II/III ACTIV-2 trial of a new fully human polyclonal antibody therapeutic, SAB-185, for treating Covid-19 in non-hospitalised individuals with mild or moderate disease.