Posted by Michael Wonder on 02 Nov 2017
FDA grants fast track designation to Visterra’s VIS410 for treatment of hospitalised patients with influenza A
1 November 2017 - Company plans to initiate Phase 2b clinical trial in early 2018.
Visterra today announced that the U.S. FDA has granted fast track designation to its lead product candidate, VIS410, a novel monoclonal antibody in development for the treatment of hospitalised patients with influenza A. Visterra is a clinical-stage biotechnology company that uses its novel Hierotope platform to identify unique disease targets and to design and engineer precision antibody-based biological medicines against such targets that are not adequately addressed with conventional approaches.
“We are pleased that the FDA has granted Fast Track designation to VIS410,” said Brian J.G. Pereira, M.D., president and chief executive officer of Visterra. “Severe influenza A is a serious disease, particularly dangerous in individuals with compromised immune systems, leading to as many as 700,000 hospitalisations and 56,000 deaths annually in the U.S. We are developing VIS410 as a single-dose treatment, and plan to initiate a Phase 2b clinical trial in hospitalised patients with influenza A in early 2018.”
