web analytics
10.3 C
Munich
Monday, April 19, 2021

Comeback Time for Relief Therapeutics Holding AG (OTCMKTS: RLFTF): RLF-100 (aviptadil)

Relief Therapeutics Holding AG (OTCMKTS: RLFTF) is making a powerful move up the charts after a brief dip in recent days. The reversal on RLFTF comes as new coronavirus cases spike proving the virus is here to stay. At the same time results coming back from the Pfizer vaccine and Lilly Mab are looking less and less promising the more we learn. This has created a perfect storm for promising biotechs such as Relief Therapeutics who’s coronavirus therapeutic 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.

Relief Therapeutics 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.

Relief Therapeutics Holding AG (OTCMKTS: RLFTF) focuses primarily on clinical-stage programs based on molecules of natural origin (peptides and proteins) with a history of clinical testing and use in human patients or a strong scientific rationale. Currently, Relief is concentrating its efforts on developing new treatments for respiratory disease indications. Its lead drug candidate RLF-100(TM) (aviptadil), synthetic vasoactive intestinal peptide (VIP), is being investigated, in cooperation with NeuroRx Inc., in two placebo-controlled U.S. Phase 2b/3 clinical trials in respiratory deficiency due to COVID-19. Relief also holds a patent issued in the United States and various other countries covering potential formulations of RLF-100(TM). Relief Therapeutics Holding AG is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF.

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(TM) 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(TM) 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. Information on the RLF-100™ Expanded Access program is here.

To Find out the inside Scoop on Relief Subscribe to Microcapdaily.com Right Now by entering your Email in the box below

RLFTF

Relief Therapeutics has been working hard behind the scenes beefing up its BOD and management team recently appointing Paul Waymack, M.D., Sc.D. as development and regulatory consultant. Dr. Waymack strengthens the management team in all activities pertaining to the late stage development of RLF-100(TM), including regulatory activities. This comes weeks after Relief appointed Jack Weinstein as Chief Financial Officer (CFO) and Treasurer, Dr. Gilles Della Corte as Chief Medical Officer and Virtuoso Sarl 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 November 5 Relief Therapeutics and its partner NeuroRx announced the independent Data Monitoring Committee (DMC) met yesterday and voted unanimously that NCT 04311697 should continue as planned to its full enrollment of 165 patients.  Specifically, the committee identified no safety concerns and viewed the study as capable of reaching its prespecified endpoint (i.e. no finding of futility) in potentially proving that RLF-100™ (aviptadil) is superior to placebo in achieving recovery from Respiratory Failure in patients with Critical COVID-19 at a statistically significant level. The review by the DMC was based on data from 102 patients who were randomly assigned to intravenous RLF-100™ vs. placebo and who have completed 28 days or more of observation.  All patients were hospitalized in intensive care units with respiratory failure treated by mechanical ventilation, non-invasive ventilation, or high-flow nasal oxygen.  So far, 133 patients have been treated in this protocol. At current rates of enrollment (which may change as infection rates change) the study is expected to complete enrollment by mid-December and yield top-line data in January 2021.

Although the study remains blinded, the randomized data overall show that there have been no drug-related Serious Adverse Events to date.  Similarly, no drug-related adverse events were seen in either the open label study of the ongoing Expanded Access Protocol. In contrast to other recently-reported trials, the RLF-100™ phase 2b/3 trial focuses on patients with Critical COVID-19 who already require intensive care for Respiratory Failure.  Currently, there is no approved drug that has shown efficacy in this population, nor are there late stage trials of other experimental therapeutics focusing on these patients. The seven-person DMC included two independent biostatisticians, an epidemiologist/clinical trials expert, a bioethicist, a public representative, and clinical experts in pulmonary and critical care medicine.

 

For more on Relief Therepuetics Subscribe Right Now!

Currently making a powerful move northbound Relief Therepuetics is one of the most exciting stories in small caps; Its lead candidate, 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. 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. Last week RLFTF and its partner NeuroRx announced the independent Data Monitoring Committee (DMC) met yesterday and voted unanimously that NCT 04311697 should continue as planned to its full enrollment of 165 patients.  Specifically, the committee identified no safety concerns and viewed the study as capable of reaching its prespecified endpoint (i.e. no finding of futility) in potentially proving that RLF-100™ (aviptadil) is superior to placebo in achieving recovery from Respiratory Failure in patients with Critical COVID-19 at a statistically significant level. 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.

Sign Up now for our 100% FREE Penny Stock Newsletter

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

More articles

1 COMMENT

LEAVE A REPLY

Please enter your comment!
Please enter your name here

Latest article

Sign up now for our 100% FREE Penny Stock Newsletter

Privacy Policy. we will never share your email with anyone.