Relief Therapeutics and NeuroRx Expand Clinical Trial Evaluating RLF-100 in Critically Ill COVID-19 Patients with Respiratory Failure to Houston Methodist Hospital...............
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by Relief Therapeutics | Jun 11, 2020
Clinical trial to enroll 144 patients total with expansion to additional sites
Clinical trial expanded to patients treated with both noninvasive and mechanical ventilation in Critical COVID-19.
RLF-100 is a patented formulation of Aviptadil (synthetic human Vasoactive Intestinal Polypeptide VIP), which inhibits pro-inflammatory cytokines and protects alveolar type-2 cells in the lungs inhibiting pro-inflammatory cytokines. Type 2 cells are essential to oxygen exchange and are preferentially targeted by the SARS-CoV-2 virus
HOUSTON, June 11, 2020 – RELIEF THERAPEUTICS Holding AG (SIX:RLF) “Relief” and its U.S. partner, NeuroRx, Inc. today announced that Houston Methodist Hospital is participating in their Phase 2 clinical trial evaluating RLF-100 as a research intervention for critically ill patients with COVID-19 and respiratory failure. RLF-100 is a patented formulation of Aviptadil, (synthetic human vasoactive intestinal polypeptide or VIP), which targets alveolar type 2 cells in the lungs that are a major target of the 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.
The multicenter clinical trial will enroll patients with COVID-19 and respiratory failure in the hopes that RLF-100 can decrease mortality in this condition and help to improve the ability of the patient’s lungs to transfer oxygen to the body. Based on recent FDA guidance, the trial has been expanded to include patients treated with high flow nasal oxygen and noninvasive forms of ventilation, instead of only enrolling patients on mechanical ventilators.
The Principal Investigator at Houston Methodist Hospital is J. George Youssef, M.D., assistant professor of Critical Care Medicine & Pulmonology. Dr. Youssef was a co-investigator in the earlier study evaluating RLF-100 as a treatment for Acute Respiratory Distress (ARDS), a primary cause of COVID-19 related deaths, under the late Professor Sami Said, who discovered VIP in 1970 and treated the first patients.
“ We are encouraged by findings from the previous clinical trial of RLF-100 as a treatment for ARDS in patients with sepsis which showed seven out of eight patients on mechanical ventilation experienced substantial improvement and six ultimately left the hospital alive,” Dr. Youssef said. “If the early ARDS results can be replicated in critically ill COVID-19 patients with respiratory failure, this approach could present a significant advancement in the treatment of these patients.”
Jonathan Javitt, M.D., MPH, CEO of NeuroRx, added, “We at NeuroRx are enormously excited to have Dr. Youssef join our study, in light of his long involvement in the VIP story. While we can read about Dr. Said’s breakthrough, Dr. Youssef witnessed it firsthand and participated in the early clinical care of patients. It’s rare to have science come full circle in service of patients.”
The trial is being led by NeuroRx, Inc., the US development partner of Relief Therapeutics, whose clinical operations are based in Radnor, PA. Patients are being treated under an FDA Investigational New Drug clearance, as part of the FDA’s Corona Treatment Acceleration Program (CTAP). Details of the study are posted on clinicaltrials.gov NCT04311697.