LAUSANNE, Switzerland, February 9, 2006 –Debiopharm S.A., the independent drug development company specialising in oncology, endocrinology, CNS and niche products presented results from a double-blind placebo-controlled study in asymptomatic chronically HIV-1-infected subjects. The aim of the study was to assess the safety of repeated oral doses of Debio-025, to determine its pharmacokinetic profile and antiviral effect in the patients. The results, presented on February 5th at the 13th Conference on Retroviruses and Opportunistic Infections in Denver, Colorado, USA, confirm the tolerability and safety of Debio-025 in the infected subjects.
Debio-025 is a synthetic first-in-class non immunosuppressive cyclosporin, being tested in humans as a potential anti-HIV-1 drug. Debio-025 binds strongly to cyclophilins, host cell proteins thought to confer a replication advantage to HIV-1. Its potent inhibitory activity on the HIV replication was shown in preclinical studies.
The results of the 10 day treatment with once daily oral doses show that Debio-025 was well tolerated at all dose levels (50, 400 and 1200mg). It was also rapidly absorbed after administration. In 11 out of 36 subjects treated with Debio-025, anti-HIV-1 activity was observed: nine showed a viral load reduction lower or equal to 0.5 log10 and two a reduction higher to 1.0 log10.
“The results of this study are promising. Debio-025 was well tolerated by the infected subjects. We are conducting a clinical study to establish the potential of Debio-025 as an anti-viral compound,” said Rolland-Yves Mauvernay, President and CEO of Debiopharm.
About Debiopharm S.A.
Founded in 1979 in Lausanne, Switzerland, Debiopharm is an experienced and competent drug development company that in-licenses compounds with promising in-vivo results to develop for global registration and to out-license to sales and marketing pharmaceutical partners.
Debiopharm is part of an established group of five complementary and synergistic companies, namely Debiovision in Canada, Debioinnovation and Debio R.P. in Switzerland and Debioclinic in France. Together, they provide drug development expertise and know-how from the evaluation of early-stage and innovative research, partnering, financing, pre-clinical and clinical trials, to manufacturing and sophisticated drug-delivery systems.
Debiopharm has developed and registered three products with combined sales in excess of $2.2bn in 2005: Eloxatin®, one of sanofi-aventis’ leading marketed products; Decapeptyl®, the leading product of Ipsen; and Trelstar® (1-and 3-month), marketed by Watson Pharmaceuticals, Inc.