Adamas Pharmaceuticals, Inc., a privately held company, announced today that it has entered into a Cooperative Research and Development Agreement (CRADA) with the United States Naval Health Research Center for preclinical studies evaluating Adamas' triple combination antiviral drug (TCAD) therapy for influenza A, including novel influenza A/H1N1. TCAD therapy includes Adamas' investigational proprietary fixed-dose oral combination drug, to be administered adjunctively with a neuraminidase inhibitor, including Tamiflu (oseltamivir phosphate, Roche).
Under the CRADA, the U.S. Naval Health Research Center will conduct comparative tests of Adamas' TCAD therapy against various strains of the influenza A virus, including seasonal influenza (H1N1, H3N2), avian influenza (H5N1) and novel influenza A/H1N1. The purpose of these studies is to assess the in vitro activity of TCAD therapy against various circulating and/or highly pathogenic strains of the influenza A virus, as well as to compare the in vitro activity of TCAD therapy to other pharmaceutical agents when used alone or in double combination. Data from these experiments will be used to advance the development of Adamas' TCAD therapy as a potential broad-spectrum antiviral therapy for serious infections caused by influenza A viruses. In addition, Adamas and the Navy's work with the novel influenza A/H1N1 virus may provide insight into this widespread public health issue.
"Collaborating with the U.S. Naval Health Research Center, with its leadership in medicine and its seminal work in discovering the novel influenza A/H1N1 virus, will significantly advance Adamas' efforts to develop TCAD therapy in response to the influenza pandemic," said Gregory Went, Ph.D., Chief Executive Officer and Chairman of Adamas. "We look forward to partnering with the Naval Health Research Center to generate data that further support the potential use of TCAD therapy for the military, healthcare workers and general public when faced with the global threat of influenza A outbreaks."
The emergence of the novel influenza A/H1N1 strain and declaration of a pandemic has highlighted the potential threat of influenza to public health and the public health system. Because of this strain's "newness" and lack of background immunity in the human population, a far larger number of people may become infected with the virus this flu season. According to the World Health Organization, the 2009 influenza pandemic has spread internationally with unprecedented speed; in past pandemics, influenza viruses have needed more than six months to spread as widely as the novel influenza A/H1N1 virus has spread in less than six weeks.
Adamas is pioneering triple-combination antiviral drug (TCAD) therapy for influenza, which is designed to inhibit viral replication at multiple points in the virus proliferation pathway. TCAD therapy includes Adamas' investigational proprietary fixed-dose combination of amantadine and ribavirin, to be administered adjunctively with a neuraminidase inhibitor such as Tamiflu (oseltamivir phosphate, Roche). Preclinical data indicate that the in vitro combination of these drugs, each with their own mechanism of action, act synergistically to provide a much higher level of antiviral activity than single or double drug combination therapies. In in vitro studies to date, TCAD therapy also has been found to provide greater antiviral activity across multiple strains of influenza, even those resistant to single pharmaceutical agents. Adamas is accelerating development of its TCAD therapy for influenza A by conducting a Phase 2 clinical trial in the Southern Hemisphere where the novel influenza A/H1N1 pandemic is active, and is preparing to initiate a clinical study of TCAD therapy for influenza A in North America during this upcoming flu season.