EVT 201: GABA_A Receptor Partial Positive Allosteric Modulator for Insomnia

Phase II proof-of-concept data suggest EVT 201 has great potential as an insomnia treatment to improve sleep onset and sleep maintenance throughout the night without residual effects.

Status: Two Phase II proof of concept trials in insomnia patients completed with positive results

EVT 201 is a novel partial positive allosteric modulator of the GABA_A receptor complex which is being developed as a treatment for insomnia. As a partial agonist EVT 201 has a very promising preclinical profile compared with full agonists acting at GABA_A, and possesses ideal pharmacokinetic properties for an insomnia drug.

EVT 201 has shown positive results in two Phase II proof-of-concept trials in primary insomnia patients using both objective (polysomnography) and subjective (patient-reported) measurements of sleep. The first phase II trial was conducted in non-elderly adults (Click here for press release) and the second trial was conducted in the elderly (aged over 65 years).

In both trials, EVT 201 produced robust and highly significant effects on sleep maintenance (reducing Wake After Sleep Onset, WASO) throughout the night and sleep onset (reducing Latency to Persistent Sleep, LPS) resulting in a significant increase in Total Sleep Time (TST).

In addition, patients reported measures of sleep showed highly significant improvements, including subjectively assessed quality of sleep. In the second trial, subjective sleep quality showed significant improvements over placebo throughout the 7 day treatment period.

Treatment with EVT 201 was completely without effect on subjectively assessed residual sedation. EVT 201 was demonstrated to be safe and well tolerated at both doses without any serious adverse events.

For the latest press release announcing headline results of the second phase II study of EVT 201 in elderly primary insomniac patients (October 16th 2007) Click here