Relief Therapeutics Holding AG (RLFTF)

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https://www.genengnews.com/category/covid-19-candidates/covid-19-definitely-maybe/

Candidate: RLF-100

Type: A synthetic human vasoactive intestinal polypeptide (VIP). VIP is known to reduce inflammation in the lungs by inhibiting inflammatory cytokines and protecting the alveolar type II cells that are believed to be an entry route for the SARS-CoV-2 to invade the lungs.

Status: Relief Therapeutics and its U.S. partner NeuroRx said June 24 that the FDA awarded its Fast Track designation to NeuroRx for investigating RLF-100 in acute lung injury/acute respiratory distress syndrome associated with COVID-19. The FDA has requested that NeuroRx submit a publicly-available expanded access policy, so that physicians may request RLF-100 for patients who are being treated in hospitals that are not participating in ongoing Phase II/III clinical trials.

Earlier in June, Relief and NeuroRx said the first patients had been treated with RLF-100 at the University of Miami Miller School of Medicine in the Phase II portion of the Phase IIb/III COVID-AIV trial (NCT04311697), designed to assess RLF-100 as a treatment for Acute Respiratory Distress Syndrome (ARDS) in COVID-19 patients on mechanical ventilation.

The multicenter randomized placebo-controlled trial aims to enroll 120 patients with COVID-19 who have ARDS and require intensive care with mechanical ventilation. Patients will be randomized to intravenous RLF-100 plus maximal intensive care or placebo plus maximal intensive care. The trial’s primary endpoints will be mortality and index of respiratory distress. The secondary endpoint will include levels of TNFa and multi-system organ failure free days

Relief and NeuroRx are also assessing RLF-100 in the the Phase IIb/III AVINALI trial (NCT04360096), a multicenter randomized placebo-controlled study which aims to enroll 144 patients with COVID-19 with shortness of breath and early pulmonary symptoms in an effort to slow COVID-19 progression.

Relief Therapeutics and NeuroRx said they are also in talks with clinical trials authorities in the European Union, the United Kingdom, Russia, and Australia.

Relief has cited recent studies suggesting that the type-2 alveolar cells were particularly vulnerable to coronavirus because of cell surface receptors that allow the virus to enter the cell. The type-2 cells are essential to replenishing the pulmonary epithelium and to manufacturing surfactant, which coats the inside of the lung and allows oxygen exchange to occur. Without surfactant, the alveolae do not stay open and blood oxygen drops quickly.

COVID-19: 200 Candidates and Counting
To navigate through the >200 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:

? FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.

? DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data.

? KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.

? TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.

GEN has also tagged the most common treatment types:

? ANTIVIRAL
? VAX
? ANTIBODY
? RNA