Abstract:
SYN023 is a mixture of two anti-rabies humanized monoclonal IgG1κ antibodies which bind to distinct and non-overlapping antigenic sites on the rabies virus glycoprotein.A Phase 2b and a Phase 3 randomized double-blinded trials were conducted to demonstrate the safety and efficacy of SYN023 in 1448 Category III rabies patients.The analysis of the safety profile of SYN023 based on the integrated data from 6 clinical trials demonstrated that SYN023 was generally well tolerated when administered alone or with rabies vaccine in subjects with rabies exposure as well as healthy subjects and has a favorable safety profile.Overall, a higher incidence of TEAEs was noted in subjects treated with HRIG than in subjects treated with SYN023.Across 6 clinical trials, RVNA appeared to be adequate at the 0.3 mg/kg dose level to rapidly establish RVNA of ≥0.5 IU/mL in the subjects. The primary endpoint for the ISE was the GMC of the RVNA on Study Day 8 in the FAS (SYN023, N=978; HRIG, N=469). The GMC ratio of RVNA (SYN023 vs HRIG) on Study Day 8 was 13.977.SYN023 was considered superior to HRIG with respect to GMC of RVNA on Study Day 8, as the lower bound of the 97.5% CI was above the prespecified margin 1.2.The immune response (RVNA ≥0.5 IU/mL) rate ratio (SYN023 vs HRIG) on Study Day 99 was 0.99.SYN023 was considered noninferior to HRIG with respect to immune response rates, as the lower bound of the 95% CI was above the prespecified margin 0.9.There were no deaths, serious adverse events, or AEs leading to study discontinuation up to 365 days after dosing.
Biography:
Dr. Eric Tsao has served as the Chief Executive Officer of Synermore Biologics since the founding of the company in 2013. He has over 25 years of industrial experience with Johnson and Johnson, AstraZeneca, and Morningside Group. His areas of expertise include biological product development, process design, facility engineering, and operations. Dr. Tsao received his Ph.D. in Chemical Engineering from the University of Michigan.
