Biotechnology company Anivive Lifesciences revealed on Wednesday the launch of two pre-clinical studies to further evaluate the in vivo efficacy, safety and the therapeutic potential of antiviral GC376 as both a treatment for COVID-19 and other coronavirus related diseases.
Earlier this year, the company has submitted a pre-Investigational New Drug (pIND) request for GC376 with the Food and Drug Administration (FDA) to advance the programme for use in humans. It has licensed the exclusive worldwide rights to GC376 from Kansas State University for use as a treatment in both humans and animals.
The company said GC376 is a novel, first-in-class, small molecule protease inhibitor with a favorable therapeutic index demonstrated in preclinical studies. A common feature of viruses in the picornavirus-like supercluster is a 3C or 3C-like protease responsible for viral replication. GC376 has been shown to be a potent inhibitor of this protease across all coronaviruses with a high therapeutic index.
In addition, the viruses in this family include human coronavirus 229E, transmissible gastroenteritis virus of swine (TGEV), murine hepatitis virus (MHV), bovine coronavirus (BCV), feline infectious peritonitis virus (FIPV), severe acute respiratory syndrome coronavirus (SARS-CoV), Middle East Respiratory Syndrome (MERS) as well as COVID-19 (SARS-CoV-2), concluded the company.
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
Eisai begins rolling sBLA to US FDA for initiation dosing of LEQEMBI IQLIK
First FDA acceptance to waive clinical efficacy studies for monoclonal antibody biosimilars
BeOne Medicines reports positive topline data for sonrotoclax in mantle cell lymphoma
Cinclus Pharma to launch Phase III trial of linaprazan glurate in erosive GERD