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 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.