Myriad Genetics reports encouraging results from Phase I HIV trial

The trial has demonstrated a favorable safety profile with Vivecon in 55 subjects enrolled across nine cohorts. The Phase I trial was designed as a single ascending dose study to assess the safety, tolerability and pharmacokinetic parameters of the compound in healthy volunteers.

The overall safety profile was favorable with no serious adverse events or clinically significant changes in laboratory values or electrocardiogram.

The observed pharmacokinetic profile supports continued development. The company said that Vivecon has good oral bioavailability and the study demonstrated enhanced absorption of Vivecon when taken with food. This is said to be an additional positive for the drug candidate since that is the preferred option to dosing on an empty stomach.

Based on these results, Myriad is proceeding to a Phase IIa study, a multiple ascending dose trial in treatment-naive HIV-infected individuals. The Phase IIa trial will further evaluate the safety, pharmacokinetic parameters and Vivecon’s ability to inhibit viral replication. This clinical development plan may allow a relatively rapid overall development timeline and accelerated initiation of pivotal studies.

Adrian Hobden, president of Myriad Pharmaceuticals, said: “Our anti-HIV program is proceeding well, led by Vivecon as a viral maturation inhibitor. The Phase I data indicates a well-tolerated drug candidate with excellent characteristics for use in the potential treatment of HIV infection.”