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AMRI obesity drug Phase I trial meets primary, secondary endpoints

AMRI's placebo-controlled Phase I clinical trial of ALB-127158(a), a novel MCH1 receptor antagonist, met primary and secondary endpoints in the treatment for obesity.

In the trial, the drug was well tolerated at all the doses tested and has demonstrated preliminary evidence of efficacy.

The trial investigated the safety, tolerability and efficacy of ALB-127158(a) in male volunteers.

The trail comprised of three components: a single ascending dose arm (SAD) in lean subjects (BMI = 25), a fed/fasted crossover in overweight subjects (BMI = 27) and a 14-day ascending dose arm (MAD) in overweight subjects.

Reductions in hunger, desire to eat, and test meal consumption were observed.

AMRI Drug Discovery senior vice president Bruce Sargent said MCH1 receptor antagonism has been long recognized as a potentially important approach to treatment of obesity, however, multiple attempts to progress therapeutic agents have been thwarted by non-target related safety issues.

"We believe that our results are the first to demonstrate good tolerability and pharmacokinetics and therefore support the further evaluation of this molecule," Sargent said.