Manhattan Pharmaceuticals reports preliminary results from AST-915 Phase 1/2 study in essential tremor

Dec 16 2010

Manhattan Pharmaceuticals, Inc. (OTCBB:MHAN) announced preliminary results today from a Phase 1/2 study of AST-915 for the treatment of essential tremor. Data from this single dose study demonstrated that AST-915 was safe and well tolerated and demonstrated a clear effect on tremor power.

In this randomized, double-blind, placebo-controlled, crossover design study, 18 subjects with essential tremor received single oral doses of AST-915. Primary and secondary outcome measures included the effect on tremor power using accelerometry to test the central tremor component at various time-points after treatment.  Safety, pharmacokinetic data and other efficacy measures were also evaluated. The study was conducted at The National Institute of Neurological Disorders and Stroke (NINDS) at the National Institutes of Health (NIH) under a CRADA agreement between the NIH and Ariston Pharmaceuticals, Inc., a wholly owned subsidiary of Manhattan Pharmaceuticals, Inc.

AST-915 was well tolerated with non-serious adverse events being evenly distributed between active and placebo treatments and two observed serious adverse events being unrelated to the study drug.

While a statistically significant effect on tremor power was not evident 80 minutes after administration of AST-915 (defined as the primary endpoint timeframe), statistically significant reductions in tremor were evident at several later time-points up to 300 minutes, the latest time-point measured following administration of AST-915. Further analysis, conducted using each subject as its own control, also demonstrated statistically significant lower tremor amplitudes in favor of AST-915 compared to placebo. Additional analysis continues to examine other secondary endpoints.

"This early positive data in subjects with essential tremor clearly demonstrates human proof of concept and indicates a need to explore the effect of higher doses and longer term administration of AST-915," said Malcolm Morville, PhD, Director of Manhattan Pharmaceuticals, Inc.

The NIH intends to submit an abstract to the 15^th International Congress of Parkinson's Disease and Movement Disorders taking place in Toronto, Ontario in June 2011. Complete study findings are expected to be disclosed at this and other scientific meetings, and by submission to scientific journals.