Relief Therapeutics Holding SA (OTCMKTS: RLFTF) is heating up fast on a surge of volume and is heading upwards again after several weeks of choppy waters. 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. Aviptadil is the first coronavirus therapeutic to demonstrate the ability to block replication of the virus in human lung cells and monocytes, while at the same time preventing synthesis of cytokines in the lungs. Aviptadil has been granted FDA Fast Track Designation and emergency use IND authorization and is showing excellent results with a number of coronavirus patients showing significant recoveries after several days of treatment.
Relief Therapeutics Holding SA (OTCMKTS: RLFTF) operating out of Switzerland aims to become a key player in the biotechnology and pharmaceutical industry. The Company provides patients with therapeutic relief from diseases for which high needs persist. Relief believes in effectively treating patients while its investors realize significant return on investment. The Company is focused on late stage clinical assets and strives to reduce development times and costs to quickly reach high quality decision-enabling results.
Relieve lead compound is RLF-100 (aviptadil) currently in advanced clinical development to treat severe COVID-19 patients. The Company has initiated a Phase IIb/III study in Acute Respiratory Distress Syndrome induced by COVID-19: in July 2020, Data Safety Monitoring Board interim safety/futility analysis of 30 patients recommended study continue as planned. In August 2020, promising results reported from the first 21 patients treated with RLF-100 under FDA Expanded Access Protocol authorization. Topline results expected in early-4th quarter 2020. The FDA has granted Emergency Use Investigational New Drug (“IND”) authorization and Expanded Access Protocol authorization granted for treatment of respiratory failure in COVID-19. Fast track designation granted by FDA for acute lung injury/ARDS associated with COVID-19. FDA IND granted to test inhaled formulation in patients with moderate and severe COVID-19 to prevent progression to respiratory failure
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In the first half of 2020 Relief appointed Dr. Gilles Della Corte as Chief Medical Officer. The Company also hired 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.
Raghuram (Ram) Selvaraju, Chairman of the Board of Relief, commented: “With the onset of COVID-19, the Relief team immediately recognized that, based on its multimodal mechanism of action, RLF-100 has a high potential to become a life-saving treatment for severe COVID-19 patients with acute lung injury. We rapidly started clinical development in the US, and I am excited about the strong progress already made in the past few months to advance this important program. The Company is fully financed to successfully complete the two US COVID-19 trials underway and is now preparing for European trials with RLF-100.”
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. According to a recent Reuters article: “Relief Therapeutics sees 60-70% chance of COVID-19 drug approval” Relief Therapeutics’ chairman said he was optimistic its RLF-100 (aviptadil) drug will win approval for treating COVID-19 patients in a matter of months. The Swiss group owns the rights to the drug in the United States and Europe. Its U.S. partner NeuroRx is running multicentre clinical trials here, including a Phase IIb/III trial in patients who are severely ill because of the consequences of COVID-19, the respiratory disease caused by the new coronavirus.
RLFTF is heating up and running northbound again after several weeks of choppy waters. 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. Aviptadil is the first coronavirus therapeutic to demonstrate the ability to block replication of the virus in human lung cells and monocytes, while at the same time preventing synthesis of cytokines in the lungs. Aviptadil has been granted FDA Fast Track Designation and emergency use IND authorization and is showing excellent results with a number of coronavirus patients showing significant recoveries after several days of treatment. 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.
