2015/04 SYN023, Synermore’s human rabies immunoglobulin antibody drug submitted IND application to FDA for the Clinical Phase I trial study
The IND application of SYN023, a human rabies immunoglobulin antibody drug, was submitted to the U.S. Food and Drug Administration (FDA) for clinical phase I study. The clinical phase I trial of SYN023 will evaluate the safety, tolerability and pharmacokinetics of SYN023 in healthy volunteers.
Founded in December 2013, Synermore Biologics Co. Ltd. has established a large number of the state-of-the-art technologies and platforms necessary for the development and production of therapeutic monoclonal antibodies, focusing on innovative biologics and high commercial potential biosimilars. The company is committed to providing effective medicines for the unmet medical need therefore contributing to human health and the economic development of Great China.
Rabies is an acute viral encephalomyelitis with a fatality rate of 100%. There are about 55000 deaths each year. The early symptoms of Rabies are nonspecific, such as fever, sore throat, chills, malaise, anorexia, vomiting, dyspnea, cough, weakness, anxiety, headache etc. or specific symptoms on the bite site. After several days, hyperactivity and fear phenomenon could appear, followed by partial paralysis, difficulty swallowing, hallucinations, and/or hydrophobia. And then there are psychosis and convulsions. If no medical treatment is taken, the patient dies within 2~6 days (sometimes a bit longer) due to respiratory paralysis. Although the incidence of rabies is lethal, but it can be properly prevented by the current available medical care. Applies vaccination before exposure to Rabies (Pre-Exposure Prophylaxis, PEP) or Applies vaccination and immunoglobulin (Rabies, Immune Globulin, RIG) after exposure to Rabies (Post Exposure Prophylaxis, PEP) can be effective for rabies prevention. WHO (WHO) and The Centers for Disease Control and Prevention (CDC) in USA recommend that if the vaccine is not injected with immunoglobulin after exposure, the immunoglobulin can be injected within 7 days at the latest.
SYN023, a mixed immunoglobulin antibody drug, is consisted of two human anti rabies monoclonal antibody CTB-011 and CTB-012. The clinical indication is for PEP treatment. The mechanism of SYN023 is that it combines with rabies virus to neutralize virus to make it lose its activity. SYN-023 has proved that it can neutralize 15 wild rabies virus strains in China and 10 strains of rabies virus in North America.
Synermore has obtained the key technology to develop and manufacture SYN023. The company has received IND approval from by the U.S. Food and Drug Administration (FDA) in May 8, 2015 for the clinical phase I study. All clinical subjects have been administered and monitored. After initiating the phase I study, and phase II trial has also been examined and approved by the FDA in July 15, 2016. All subjects are expected to be administered and monitored for phase II study in May 2017. Synermore has been seeking IND approval from CFDA, and the company planned to manufacture SYN023 and sell it in China in the future. The global sales of rabies immunoglobulin are estimated to be about 500 million US dollars, and the market is huge. It is expected to create considerable revenue for the company.