Drug development company NeuroRx Inc revealed on Monday that Aviptadil has been identified by the National Institutes of Health (NIH) as one of two drugs selected for inclusion in the upcoming phase III multicentre COVID-19 clinical trial across the US and other countries.
The company added that Aviptadil is being developed under the name ZYESAMI in collaboration with Relief Therapeutics Holding AG (SIX:RLF,OTCQB:RLFTF).
Designated as TESICO (Therapeutics for Severely Ill Inpatients with COVID-19), the trial is funded by the US Government COVID-19 Therapeutics Response and sponsored by the National Institute of Allergy and Infectious Diseases (NIAID).
Upon review and approval as phase III trial by the US Food and Drug Administration, TESICO will randomly allocate 640 participants to Aviptadil, Remdesivir, the combination of both drugs and placebo. Remdesivir is marketed as Veklury by Gilead Sciences (Nasdaq:GILD).
In addition, the primary endpoint of the TESICO COVID trial will be participant recovery from respiratory failure over 90 days. Additional information will be supplied by the NIH when the trial randomizes its first patients, concluded the company.
Meant Health announces expansion of telehealth access for FDA-approved GLP-1 prescriptions
US FDA grants orphan drug designation for Lundbeck's asedebart
Renova Pharmaceuticals launches first three US generic products
FDA grants Priority Review to Genentech's Enspryng for MOGAD
Biophytis expands BIO101 obesity study to assess weight regain
THX Pharma secures European patent for Batten-1 in juvenile Batten disease
Etcamah–CDK4/6 inhibitor combination approved in US for ESR1-mutated HR-positive breast cancer
Guardant Health wins FDA approval for Guardant360 CDx in advanced breast cancer