The Phase II, double-blinded placebo controlled 12-week dosing trial will enroll approximately 90 patients who are stable on metformin treatment only, the current first-line therapy for type 2 diabetes, with a hemoglobin A1c (HbA1c) level in excess of 7.5%.
The primary endpoints for the trial will be safety and a reduction in HbA1c. Hollis-Eden plans to complete enrolment by the end of 2008 and release preliminary interim data from this trial in the fourth quarter of 2008.
Richard Hollis, chairman and CEO of Hollis-Eden, said: “Since Triolex targets inflammation as an underlying cause of type-2 diabetes, the compound, if successfully developed, holds the promise to become a first-in-class treatment option with competitive advantages over existing therapies in the marketplace.
“In addition, since we believe Triolex is acting as a novel anti-inflammatory, the compound may have benefit in other diseases as well. Accordingly, in this Phase II study we will be evaluating the ability of the compound to affect a number of other markers associated with low-grade inflammation.”