China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) announced receiving ethical approval for a Phase II clinical study protocol for its Category 1.1 chemical drug HY3000 nasal spray targeting COVID-19. The clinical filing for the product was accepted for review by the National Medical Products Administration (NMPA) in August 2022.
Study Design and Objectives
The randomized, double-blind, placebo-controlled Phase II study is designed to assess the efficacy and safety of HY3000 nasal spray in the pre-exposure prevention of severe acute respiratory syndrome coronavirus type 2 (SARS CoV-2) infection.
HY3000: Mechanism and Benefits
HY3000, a new type of polypeptide membrane fusion inhibitor binding to the HR1 region of the new coronavirus spike protein, prevents the formation of the six-helix bundle structure of the virus and blocks the virus from infecting cells to achieve an antiviral effect. HY3000 has a novel mechanism of action and a conservative action site. It is not affected by the mutation of the new coronavirus, and has high activity against the main epidemic strains, such as Omicron. It is administered by nasal spray, directly acts on the respiratory tract where the virus invades the human body, and suppresses the virus in advance.-Fineline Info & Tech