Posted on 10/15/2020 8:10:24 PM PDT by rxsid
New Drug Promises “Rapid Recovery From Respiratory Failure”
“Overall, 81% of RLF-100™-treated patients survived beyond 60 days, compared to 17% of control patients.”
Oct 13, 2020
GENEVA and RADNOR, Pa., Oct. 13, 2020 /PRNewswire/ – RELIEF THERAPEUTICS Holding AG and NeuroRx, Inc., today announced topline results from 45 patients assessed in an open-label prospective study where 21 patients admitted to an intensive care unit (ICU) with critical COVID-19 and respiratory failure were treated with RLF-100™(aviptadil) and compared to 24 control patients treated in the same setting.
All patients had severe comorbidities 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.
Overall, 81% of RLF-100™-treated patients survived beyond 60 days, compared to 17% of control patients. Patients treated with RLF-100™ demonstrated a 9-fold increased probability of survival and recovery from respiratory failure, with a high degree of statistical significance. Statistical analysis was performed by Prof. Phil Lavin, FASA, FRAPS of the Boston Biostatistical Research Foundation.
J. Georges Youssef, MD, section chief of General Academic Pulmonary Medicine at the Houston Methodist Hospital, who serves as the study’s principal investigator at Houston Methodist and also serves as national co-chair for the ongoing randomized controlled trial, said:
“We are encouraged by these initial results in highly comorbid patients with COVID-19 respiratory failure, and we are pleased that the majority of these patients have returned safely to their families. We look forward to the upcoming results from the randomized, double-blind, prospective trial in less severely comorbid patients for confirmation of these results,”
Dr. Jonathan Javitt, CEO and Chairman of NeuroRx, Inc. said:
“The patients included in this study are representative of those who are too ill to be included in the clinical trials of any known treatment for COVID-19.“We are grateful to Dr. Youssef and to the Houston Methodist Hospital for having the courage to treat and study patients at this level of risk. The results suggest that there may be substantial hope to mitigate the attack of the coronavirus on the delicate cells that line the lung with a natural peptide that has been protecting the lung’s lining since humans first walked the earth. While the number of patients treated at Houston Methodist is modest, the initial results in our nationwide expanded access program suggest similarly encouraging survival with RLF-100™. We continue to closely monitor treatment with RLT-100TM in other hospitals.”
Raghuram (Ram) Selvaraju, Chairman of the Board of Relief commented: “The encouraging EAP topline data give us continued motivation to remain focused on the rapid clinical development of RLF-100™. We look forward to topline results from our randomized, placebo-controlled study this quarter. We remain dedicated to our goal of providing therapeutic relief to critical COVID-19 patients as quickly as possible.”
About RLF-100™
RLF-100™ (aviptadil) is a formulation of Vasoactive Intestinal Polypeptide (VIP) that was developed based on Prof. Sami Said’s original work at Stony Brook University, for which Stony Brook was awarded an FDA Orphan Drug Designation in 2001. VIP is known to be highly concentrated in the lungs, where it inhibits coronavirus replication, blocks the formation of inflammatory cytokines, prevents cell death, and upregulates the production of surfactant.
FDA has now granted IND authorization for intravenous and inhaled delivery of RLF-100™ for the treatment of COVID-19 and awarded Fast Track designation. RLF-100™ is being investigated in two placebo-controlled US Phase 2b/3 clinical trials in respiratory deficiency due to COVID-19. Since July 2020, more than 150 patients with Critical COVID-19 and Respiratory Failure have been treated with RLF-100™ under FDA-approved protocols.
Information on the RLF-100™ Expanded Access program can be found here.
The promising COVID therapy for respiratory failure few have heard of, but will soon - NeuroRx and Relief Therapeutics RLF-100 (Aviptadil)
http://www.freerepublic.com/focus/f-news/3871736/posts
FDA Lets NeuroRx, Relief Therapeutics Test RLF-100 in COVID-19 Patients (Aviptadil)
http://www.freerepublic.com/focus/f-chat/3871979/posts
This needs to get approved, including the inhaled version for less serious covid infections, so we can get our country (& the world) back from the covid abyss. A bonus for some/many, this isn't a vaccine.
New Drug Promises “Rapid Recovery From Respiratory Failure” (Covid-19 Therapeutic)
Thanks.
Hard to keep up with all the advances.
This one sounds extremely promising.
Very interesting.
It needs play, because this disease is now slowing but surely being treated into oblivion. Once the deaths are minimized, its harder to spread fear.
Also used in conjunction with phentolamine AND sexual stimulation to treat organically occuring ED. Both meds are injected..
Fake News will be all over this with a seek and destroy mission!
Progress is great, but I can’t tell if the comments using the words hard and harder are joking about the drug’s other use.
In case they were not joking — it will make America stand tall again.
The Woo-Hoo Floo plandemic will be history November 4, 2020.
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.