NeuroRx and Relief announce initial successful results from expanded access use of RLF-100™ (aviptadil) in patients with Critical COVID-19 and Severe Comorbidity: 72% survival seen in ICU patients
RADNOR, Pa. and GENEVA, Nov. 24, 2020 /PRNewswire/ -- NeuroRx, Inc., and Relief AG (SIX: RLF, OTCQB: RLFTF), announce that more than 175 patients with Critical COVID-19 and Respiratory Failure who also have a severe comorbidity have now been entered into an Expanded Access Protocol (EAP) with RLF-100TM in the United States.
All patients had severe comorbidities (such as organ transplant, recent heart attack, and cancer) that rendered them ineligible for the ongoing randomized, controlled phase 2b/3 trial being conducted to ascertain safety and efficacy of RLF-100™, and all patients were deteriorating despite treatment with approved therapies for COVID-19 (see www.clinicaltrials.gov NCT 04311697). Of the 90 patients who have so far reached 28 days of follow-up, 72% survived to day 28.
As previously reported by Youssef and coworkers (http://dx.doi.org/10.2139/ssrn.3665228), at Houston Methodist Hospital, 21 patients treated with RLF-100™ under the EAP were compared to 24 control patients treated in the same setting. Only 17% of the control patients, all treated with best available intensive care unit (ICU) Standard of Care, survived to day 28. The survival rate with RLF-100TM reported today is comparable to that seen among the open-label patients treated with RLF-100™ by Youssef et al. Despite advancements in treating COVID-19, survival for the patients at highest risk due to severe comorbidities has remained dismal in the absence of an effective therapy.
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™ vs. placebo in the U.S. phase 2b/3 clinical trial currently underway. Thus, from a risk/benefit perspective, while the benefit of RLF-100TM 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™ 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-100TM. As patients are treated earlier in the course of their ICU stay, there is an emerging clinical impression that RLF-100TM has an even greater impact on recovery.
"We are reassured that emerging real-world data on the use of RLF-100TM 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.
ABOUT VIP IN LUNG INJURY
COVID-19-related death is primarily caused by respiratory failure. Before this acute phase, however, there is evidence of early viral infection of the alveolar type 2 cells. These cells are known to have angiotensin converting enzyme 2 (ACE2) receptors at high levels, which serve as the route of entry for the SARS-CoV-2 into the cells. Coronaviruses are shown to replicate in alveolar type 2 cells but not in the more numerous type 1 cells. These same type 2 alveolar cells have high concentrations of VIP receptors on their cell surfaces giving rise to the hypothesis that VIP could specifically protect these cells from injury.
Injury to the type 2 alveolar cells is an increasingly plausible mechanism of COVID-19 disease progression (Mason 2020). These specialized cells replenish the more common type 1 cells that line the lungs. More importantly, type 2 cells manufacture surfactant that coats the lung and are essential for oxygen exchange. Other than RLF-100™, no currently proposed treatments for COVID-19 specifically target these vulnerable type 2 cells.
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RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on the OTCQB under the symbol RLFTF.
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Disclaimer: This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG, NeuroRx, Inc. and their businesses. The results reported herein may or may not be indicative of the results of future and larger clinical trials for RLF-100™ for the treatment of COVID-19. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding AG and/or NeuroRx, Inc. to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
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