Adamas Pharmaceuticals expands its Phase 2 TCAD therapy study for influenza A

Adamas Pharmaceuticals, Inc., a privately held company, announced today that it has expanded its Phase 2 clinical study of a proprietary investigational triple-combination antiviral drug therapy for influenza to include centers in the United States, Canada and Europe. The study, which was initiated in August 2009 in the Southern Hemisphere, is designed to investigate Adamas' triple combination antiviral drug (TCAD) therapy as a treatment for influenza A, including novel influenza A/H1N1, the cause of the current flu pandemic. TCAD therapy consists of Adamas' proprietary combination of amantadine and ribavirin administered adjunctively with a neuraminidase inhibitor such as oseltamivir. The study is designed to assess the ability of TCAD therapy to suppress replication of the influenza A virus, alleviate symptoms from subjects and impede the development of resistance.

"Immune-compromised patients are at increased risk for life-threatening complications from influenza infection, and therefore the development of a broad-spectrum anti-influenza treatment is critical for this underserved population," said Gregory Went, Ph.D., Chief Executive Officer and Chairman of Adamas. "We have accelerated our development efforts to generate clinical data that demonstrate how TCAD therapy can address the needs of influenza patients in light of the prevalence of novel influenza A/H1N1 flu this season and growing concerns about the emergence of antiviral resistance during treatment with single neuraminidase inhibitors like oseltamivir."

The study, AAVID-1(TM) (Adamas Antiviral Influenza Drug), is a Phase 2, open-label, randomized study that will enroll during the 2009/10 influenza season up to 250 immune-compromised adults and children with influenza A in up to 45 study sites. The study's primary endpoint is the time to clearing of viral shedding. Study participants will include patients ages one to 65 who are immune-compromised due to receiving chemotherapy or immunosuppressive medications, or who are HIV positive. The protocol calls for study participants to be randomized to receive either the TCAD therapy comprised of amantadine and ribavirin with oseltamivir or oseltamivir monotherapy for 10 days. The follow-up period will be six months following treatment and an Independent Data Monitoring Committee will monitor the safety of participants throughout the duration of the study.

"There is a clear need for alternative antiviral strategies to treat influenza, especially for immune-compromised patients at risk for development of drug resistance and severe clinical outcomes," said Menno de Jong, M.D., Ph.D., professor in Clinical Virology at the Department of Medical Microbiology, Academic Medical Centre of the University of Amsterdam, and Chair of the Protocol Steering Committee for this Phase 2 trial. "Based on preclinical results showing that Adamas' triple combination of amantadine, ribavirin, and oseltamivir is synergistic in its ability to block replication of the influenza virus, I believe Adamas' approach has much potential, and look forward to being involved in this study."