The Phase IIa trial is a multicenter, randomized, double-blind, placebo-controlled study primarily investigating the safety and tolerability of EHT 0202 in approximately 150 patients with Alzheimer’s disease. The effect of two different doses of EHT 0202 as adjunctive therapy to an acetylcholinesterase inhibitor will be evaluated in comparison to placebo.
Ambulatory patients suffering from mild to moderate Alzheimer’s disease are randomized and receive oral treatment, twice a day, of either 40 or 80mg of EHT 0202, or placebo over a three-month period.
The study design will also allow for the collection of preliminary data related to many clinical efficacy parameters of EHT 0202, notably including a battery of cognitive assessments (ADAS-Cog, NTB, MMSE) but also assessment of patients’ daily living activities, global assessment and behavior, the company said. Study results will be available in the fourth quarter of 2009.
Loic Maurel, president of the management board of ExonHit Therapeutics, said: “The successful completion of patient enrollment for the Phase IIa represents an important milestone in the development of EHT 0202, and provides a clear timeline for the release of results.
“Our strategy is to bring EHT 0202 up to the end of the ongoing study and then to look for a partner to move EHT 0202 through further clinical development. We have already met with several pharmaceutical companies that are looking forward to the Phase IIa results.”