EQS-News

NeuroRx and Relief announce initial successful results from expanded access use of RLF-100(TM) (aviptadil) in patients with Critical COVID-19 and Severe Comorbidity: 72% survival seen in ICU patients - Seite 2

Notably, in the EAP, no drug-related Serious Adverse Events have been reported to date among these patients nor the 160 patients randomized to RLF-100(TM) vs. placebo in the U.S. phase 2b/3 clinical trial currently underway. Thus, from a risk/benefit perspective, while the benefit of RLF-100(TM) has not yet been proven in a randomized prospective trial, no serious risk has been identified so far.

Currently, 25 U.S. hospitals have enrolled patients in the EAP, nearly all of which are community hospitals, suggesting that RLF-100(TM) can demonstrate effectiveness in the hands of front-line physicians who deliver the majority of care to patients with Critical COVID-19. Physicians enrolling patients in the EAP have routinely reported that initial patients at their sites have frequently been in the ICU for several weeks without recovery prior to treatment with RLF-100(TM). As patients are treated earlier in the course of their ICU stay, there is an emerging clinical impression that RLF-100(TM) has an even greater impact on recovery.

"We are reassured that emerging real-world data on the use of RLF-100(TM) in improving survival in patients with Critical COVID-19 are comparable to results seen in the hands of major academic teaching centers. We hope that these findings are viewed as encouraging at a time when many Americans, including the doctors, nurses, and other front-line caregivers who are the heart of our initiative, are celebrating the Thanksgiving holiday at a distance from their loved ones. We look forward to completing enrollment and reporting the results of our pivotal U.S. clinical trial," said Prof. Jonathan C. Javitt, MD, MPH, CEO and founder of NeuroRx, Inc.

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ABOUT VIP IN LUNG INJURY
Vasoactive Intestinal Polypeptide (VIP) was first discovered by the late Dr. Sami Said in 1970. Although first identified in the intestinal tract, VIP is now known to be produced throughout the body and to be primarily concentrated in the lungs. VIP has been shown in more than 100 peer-reviewed studies to have potent anti-inflammatory/anti-cytokine activity in animal models of respiratory distress, acute lung injury, and inflammation. Most importantly, 70% of the VIP in the body is bound to a rare cell in the lung, the alveolar type 2 cell, that is critical to transmission of oxygen to the body. VIP has a 20-year history of safe use in humans in multiple human trials for sarcoidosis, pulmonary fibrosis, asthma/allergy, and pulmonary hypertension.