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.
Zhimeng Biopharma's investigational drug gains Phase 2 epilepsy clinical trial approval in China
Sanofi's SAR402663 granted FDA fast track designation for wet AMD
Implantica produces 10,000 RefluxStop units ahead of planned US launch
Sobi's Biologics License Application for NASP in uncontrolled gout accepted by FDA
Ionis receives FDA Breakthrough Therapy designation for ION582 in Angelman syndrome
Saol Therapeutics receives US FDA Complete Response Letter for SL1009 (DCA) in PDCD
Amneal's risperidone extended-release injectable suspension approved by US FDA
Brain+ pilot shows Ayla therapy boosts cognitive outcomes in dementia care
Ascelia Pharma files NDA with FDA for liver imaging drug Orviglance
Biophytis secures EMA clearance to advance Phase 2 obesity trial
Valneva reports strong Phase 2 booster results for Lyme disease vaccine candidate VLA15