Penwest initiates Phase Ib mitochondrial diseases trial

Penwest Pharmaceuticals, a drug development company, has started dosing in a Phase Ib clinical trial of A0001, a compound the company is developing for the treatment of mitochondrial diseases.

The Phase Ib trial is a single-blind, placebo-controlled, multiple ascending dose clinical trial in healthy subjects. The trial is designed to evaluate the safety and tolerability of A0001 and characterize the pharmacokinetic profile following repeat dosing. Penwest plans to enroll a total of 30 healthy volunteers in the trial. The company expects to announce data from this trial in the second quarter of 2009.

Following completion of this safety trial, Penwest expects to conduct a Phase IIa trial in patients with mitochondrial respiratory chain disease in the second half of 2009. In parallel with the Phase Ib trial, the company has initiated long-term animal toxicology studies to support the clinical program.

Jennifer Good, president and CEO of Penwest, said: We are very pleased to advance A0001 into the next phase of its development. We are now planning our Phase II clinical program to evaluate the biological activity of the compound, which will be conducted in the second half of 2009.

Penwest is a drug development company focused on identifying, developing and commercializing products that address unmet medical needs, primarily for disorders of the nervous system.