Research & Development
FDA grants Expanded Access Protocol to RLF-100 for Respiratory Failure in COVID-19
29 July 2020 - - Switzerland-based Relief Therapeutics Holding AG (SIX: RLF) (OTC: RLFTF) and its US partner, NeuroRx, Inc. said the US FDA has granted an Expanded Access Protocol for treatment of Respiratory Failure in COVID-19 with RLF-100 (aviptadil), a synthetic form of Vasoactive Intestinal Peptide.

The protocol makes treatment available to patients who have exhausted standard therapies and are not eligible for the current phase 2/3 trial of RLF-100 because of confounding medical conditions and specifically makes the treatment available to pregnant women.

Although the drug remains under investigation, rapid recovery from respiratory failure in COVID-19 has been seen in patients treated under FDA Emergency Use authorisation.

Physicians who wish to enroll their patients in the protocol must submit the protocol to their local investigational review board and file FDA form 1572 with NeuroRx, Inc.

The SARS-CoV-2 coronavirus that causes COVID-19 attacks the body by entering the small population of Alveolar Type II cells in the lung.

Without Type II cells, the lung cannot transmit oxygen, which why the coronavirus causes acute respiratory failure.

50 years of scientific research demonstrates that VIP binds specifically to the Type II cell and protects that cell against cytokines (inflammatory molecules) and a wide array of toxic and infectious injuries."

The Relief group of companies focus primarily on clinical-stage projects based on molecules of natural origin (peptides and proteins) with a history of clinical testing and use in human patients or a strong scientific rational.

Currently, Relief is concentrating its efforts on developing new treatments for respiratory disease indications.

Relief Therapeutics holds orphan drug designations from the US Food and Drug Administration and the European Union for the use of VIP to treat ARDS, pulmonary hypertension, and sarcoidosis. Relief Therapeutics also holds a US patent4 for RLF-100 and proprietary manufacturing processes for its synthesis.
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