Relief Therapeutics launches tests to treat respiratory failure in COVID-patients

Acute respiratory distress syndrome (ARDS) is a type of respiratory failure characterized by the rapid onset of widespread inflammation in the lungs. Symptoms include shortness of breath, rapid breathing, and bluish skin coloration. Among those who survive, a decreased quality of life is relatively common. The Geneva-based Relief Therapeutics Holding SA  is initiating an urgent phase 2 clinical trial of RLF-100 (Aviptadil) in coordination with the Senior Leadership of the Government of Israel for the treatment of ARDS in patients with COVID-19 infection.  Aviptadil is Vasoactive Intestinal Polypeptide (VIP), a naturally-occurring peptide hormone that is known to be concentrated in the lungs. 

Building on the success of the Phase 1/2 trials in which Aviptadil demonstrated clinical benefit of pulmonary arterial hypertension, sarcoidosis, and ARDS, Relief is initiating proof-of-concept trials phase 2 studies to treat ARDS in COVID-19 patients. The drug candidate has Investigational New Drug clearance from the US FDA and the European Medicines Agency for phase 2 trials in ARDS and has been awarded orphan drug designation by both agencies for the treatment of ARDS, Acute Lung Injury, and Sarcoidosis.

The first clinical protocol will compare intravenous administration of Aviptadil to its administration via an endotracheal tube COVID-19 patients who are already on mechanical ventilation because of ARDS. Assuming no new safety signals are detected, a second protocol will quickly be initiated to treat patients with early signs of respiratory distress in the hopes of preventing progression to ARDS and the need for mechanical ventilation.

“After carefully reviewing the preclinical and clinical data, we believe that RLF-100 has a chance to be a safe and effective treatment for ARDS in patients infected by COVID-19, who otherwise have less than 50% chance of survival, despite intensive care. The State of Israel is eager to test this potentially lifesaving treatment in patients who today have no other therapeutic option, said Halberthal. We will try every possible mechanism to help safeguard our patients in this global crisis.

The trial is being coordinated by Jonathan Javitt, acting Chairman of the Scientific Advisory Board of Relief in coordination with Miki Halberthal, CEO of the Rambam Healthcare Campus and  Boaz Lev, head of Israel’s COVID task force and former Director-General of Israel’s Ministry of Health.

(Press release/ran)