RodgerRodger schreef op 30 december 2021 07:23:
We would like to draw your attention to the following ad hoc announcement pursuant to Art. 53 LR of RELIEF THERAPEUTICS Holding SA:
Relief Reports that its U.S. Collaboration Partner has Announced it has Filed a Breakthrough Therapy Designation Request for Aviptadil in Patients at Immediate Risk of Death from COVID-19 Despite Treatment with Remdesivir and Other Approved Therapies
Geneva, Switzerland, December 30, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its collaboration partner, NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx”), has announced it has filed for a new Breakthrough Therapy Designation (“BTD”) request with the U.S. Food and Drug Administration (“FDA”) focused on patients with Critical COVID-19 and respiratory failure who are at immediate risk of death despite treatment with Remdesivir and other approved therapies. According to the press release, the BTD request is based on an FDA request for clinical data on the effectiveness of aviptadil compared to Remdesivir and other approved therapies. The press release also reported patients treated with aviptadil vs. placebo demonstrated a statistically significant (P=.03) 2.8-fold increased odds of being alive and free of respiratory failure at day 28 and day 60 and a highly significant (P=.006) four-fold increased odds of survival is seen in these patients. The related NRx press release can be accessed through the following link.