OBECURE BEGINS TRIAL OF DRUG TO COUNTER ZYPREXA WEIGHT GAIN

Obecure has begun a Phase II clinical trial to evaluate the efficacy of the company's OBE101 drug candidate for prevention of weight gain in patients treated with Zyprexa, an antipsychotic medication. The study is a four-month, double-blinded, placebo-controlled, multicenter trial in 78 subjects. The study, approved by Health Canada, will be conducted at several psychiatric medical centers across Canada. The trial is being conducted with the partial financial support of Eli Lilly, the manufacturer of Zyprexa.

"Significant weight gain has been an unwanted side effect among patients taking Zyprexa," Joseph Albeck, principal investigator of the study, said. "Our goal in this study is to see if combining OBE101 with Zyprexa will prevent the weight gain without interfering with the antipsychotic benefits."

Zyprexa and OBE101 both act on the histamine receptor in the brain, which controls the appetite, according to the company. Whereas Zyprexa, an inhibitor of the histamine receptor, triggers eating, OBDE101, an activator of the receptor, suppresses food craving and is expected to to offset the effect of Zyprexa.

In addition, the NIH has agreed to undertake a study enrolling 80 patients that will examine the drug's mechanism of action by evaluating its impact on energy consumption and expenditure.

OBE101 contains betahistine, a drug currently prescribed for vertigo in many countries. However, the drug is not FDA-approved and is therefore not available in the U.S. A recent postmarketing survey showed that the drug has a favorable safety profile, Obecure said.