The study, a phase II double-blind, placebo controlled, multi-dose study in treatment-experience HIV patients, assessed SP01A’s safety and effect on viral load in HIV-1 positive individuals, with evidence of increasing viral load, despite treatment with antiretroviral therapy.
In the preliminary finding, SP-01A was found to have a 0.4 log10 difference between the high dose group, which received SP-01A 800mg/day and the placebo control group.
In addition, there was a dose dependent relationship in the number of subjects who had a reduction in viral load with the 800mg/day dose group showing the most difference as compared to placebo (55% vs. 0%, respectively).
“Clinically SP-01A has always been tested in concert with other antiretroviral drugs, this is the first time it was tested alone. We are very encouraged with the results and look forward to developing SP-01A to hopefully be the first orally administered entry cell inhibitor drug with a ‘firewall’ mechanism of action,” stated Dr Greeson, CEO of Samaritan Pharmaceuticals.