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Saturday, September 24, 2022

RLF-100™ (Aviptadil) Relief Therapeutics Holding AG (OTCMKTS: RLFTF) Heats Up Fast

Relief Therapeutics Holding AG (OTCMKTS: RLFTF) is surging up the charts in recent trading since a recent test of the bottom of its current trading range. Relief Therapeutics is quickly emerging as among the most exciting stories in small caps as its coronavirus therapeutic RLF-100 (aviptadil) gains serious traction. The Company recently raised approximately USD $36 million which will be used primarily to fund the ongoing Fast Track FDA trial of RLF-100 (aviptadil) in coronavirus acute respiratory distress syndrome (NCT04311697) as well as to run a phase 3 study in Europe.

RLFTF took off in the last week of July after the FDA granted expanded access protocol for treatment of Respiratory Failure in COVID-19 with RLF-100. The Company has come a long way since then recently reporting highly encouraging topline efficacy data from patients treated with RLF-100™ (aviptadil) under the U.S. FDA Expanded Access Protocol authorization for respiratory failure related to critical COVID-19. Investors are looking forward to the upcoming results from the randomized, double-blind, prospective trial.

Relief Therapeutics Holding SA (OTCMKTS: RLFTF) is a biopharmaceutical company with its lead compound RLF-100TM (aviptadil) in advanced clinical development to treat severe COVID-19 patients. Operating out of Switzerland, the Company is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on the OTCQB under the symbol RLFTF.

Relief lead product; 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. RLF-100 is believed to be the first COVID-19 therapeutic to demonstrate the ability to block replication of the SARS-CoV-2 virus in human lung cells and monocytes, while also preventing synthesis of cytokines in the lung. Since July 2020, severe COVID-19 patients have been treated with RLF-100 under U.S. FDA Emergency Use Investigational New Drug (IND) authorization and Expanded Access Protocol authorization for the treatment of respiratory failure in COVID-19. 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. Relief Therapeutics (OTC:RLFTF) makes it into the Coronavirus Technology Watch Program which is administered by the US Department of Health and Human Services.

Relief and its partner NeuroRx have established supply chain agreements and ordered sufficient drug substance (RLF-100TM) to prepare to treat 1 million patients with COVID-19. The partners contracted with Nephron Pharmaceuticals, Inc., Bachem Americas, as well as a leading nationwide pharmaceutical logistics partner in order to ensure overnight commercial supply to US hospitals, should RLF-100™ continue to succeed.

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Relief continues to beef up its BOD and management team recently appointing Jack Weinstein as Chief Financial Officer (CFO) and Treasurer. The Company has also appointed Dr. Gilles Della Corte as Chief Medical Officer. The Company also appointed Virtuoso Sarl, a strategic and tactical operational and trial delivery services firm, as Clinical Trials Manager to set up and run RLF-100 clinical trials in Europe. Relief successfully upgraded from US OTC Pink to OTCQB, meeting all qualifications and raised $34.4 million via its Share Subscription Facility in July and August.

On October 13 Relief reported 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.Scientific findings of the analysis have been submitted for peer review.

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RLFTF recently reported highly encouraging topline efficacy data from patients treated with RLF-100™ (aviptadil) under the U.S. FDA Expanded Access Protocol authorization for respiratory failure related to critical COVID-19. Jihad 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 stated: “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.” 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.” Microcapdaily covers Relief on the regular and first reported on the Company on August 3 as Relief was running northbound off its $0.05 base. We will be updating on Relief on a daily basis so make sure you are subscribed to microcapdaily.com so you know what is going on with Relief.

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Disclosure: we hold no position in Relief either long or short and we have not been compensated for this article.

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