Biopharmaceutical company SAB Biotherapeutics (SAB) on Saturday provided an update of the interim analysis of the defined safety and efficacy data of SAB-185 in the phase 2 part of the ACTIV-2 study, following an independent Data Safety Monitoring Board (DSMB ) review.
The company said SAB-185 is a fully human, targeted, broadly neutralizing polyclonal antibody drug candidate for the treatment of non-hospitalised patients with mild to moderate COVID-19.
SAB-185 is being tested in the ACTIV-2 study, which is funded and carried out by the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the NIH (National Institutes of Health, USA) - in collaboration with the AIDS Clinical Trials Group.
According to the company, the lower and higher doses of SAB-185 tested in phase 2 met the pre-defined efficacy target for transition to phase 3 and were shown to be safe in the interim analysis. The NIAID and SAB researchers are currently in the process of determining the preferred dose for the Phase 3 trial. SAB-185 is being transferred to phase 3 study upon meeting defined promotion criteria.
SAB added that the Phase 3 portion of the ACTIV-2 study is a randomized, open-label, active comparator-controlled, adaptive platform study to evaluate the clinical safety and efficacy of SAB-185 compared to active control treatment with a monoclonal antibody in patients with mild to moderate COVID-19, who have a higher risk of hospitalisation. The primary outcome measured the safety and non-inferiority to prevention of a composite endpoint defined as either hospitalisation or death from any cause by study day 28.
Inimmune signs research collaboration with Boston Children's Hospital
ResVita Bio receives USD250,000 phase one Small Business Innovation Research grant from NIAID
Phase II Data of Oral Dexpramipexole Published in Eosinophilic Asthma
AllerVie Health Rebrands Southern Allergy & Asthma
Applied BioCode Inks Distribution Agreement with Medline Industries
Vedanta Biosciences Receives Fast Track Designation for VE303
KalVista Pharmaceuticals Presents Data at 13th C1-inhibitor Deficiency & Angioedema Workshop
French Ophthalmology Specialist Horus Pharma Group Launches a Nordic Subsidiary