Evotec reports strong results for AD trial

German small-molecule drug development firm Evotec says its EVT 101 has performed well in a Phase Ib safety study targetted for a marketing submission in the treatment of Alzheimer's disease.

The double-blind study was designed to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics during prolonged dosing with EVT 101, an orally-active NR2B-subtype selective antagonist of NMDA receptors with potential in Alzheimer's disease, neuropathic pain and other indications, versus placebo, but at higher dose levels and for a longer duration that the previous Phase I study, the company noted.

EVT 101 was administered to 48 young and elderly healthy subjects over four weeks. The drug was well tolerated in both groups up to the highest dose tested (12mg/day in elderly, 15mg/day in young subjects). No severe or serious adverse events were reported, and only a few transient, mostly mild, side effects occurred. This safety and tolerability profile is extremely encouraging as the doses evaluated are predicted to be well into the anticipated therapeutic range, said the firm.