The FDA has signed off on a Phase 2/3 clinical trial, AVICOVID-2, evaluating an inhaled formulation of Relief Therapeutics’ (OTCPK:RLFTF) lead candidate RLF-100 (aviptadil) in moderately to severely ill COVID-19 patients to prevent progression to respiratory failure.
The study, led by collaboration partner NeuroRx, will enroll ~288 subjects. The primary endpoint is the proportion of patients progressing to acute respiratory distress syndrome (ARDS) compared to placebo (both on top of standard-of-care treatment). The estimated primary completion date is October.
Aviptadil, a synthetic form of human vasoactive intestinal peptide (VIP), works by binding to receptors on alveolar cells in the lungs, the same cells that SARS-CoV-2 binds to. The company says VIP protects these cells and the surrounding pulmonary epithelium by blocking cytokines, preventing cell death and upregulating the production of surfactant, the loss of which is believed to play a role in COVID-19 respiratory failure.
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