“Our preliminary human study demonstrates that OBE101, comprised of betahistine, offers a promising new approach to meet that need. Betahistine has a proven safety profile and has been shown to be effective in weight reduction in pilot studies,” said Yaffa Beck, CEO of Obecure.
Betahistine is currently marketed in many countries for the treatment of vertigo. The drug was first approved in the mid 1960's but was taken off the US market by the FDA for lack of clinical evidence in that indication. A recent post-marketing survey shows that the drug has a strong safety profile.
The idea for using betahistine in weight management is based on research that successfully demonstrated the key role that histamine receptors play in controlling appetite and food consumption and the beneficial effect that activating these receptors can have in suppressing the desire for fat consumption.
In a pilot study, involving 20 human subjects over four weeks, the drug reduced both calorie and fat intake in the treatment group, resulting in significant weight loss versus placebo. In an independently conducted study, betahistine was also shown to successfully counteract the blocking of the histamine receptor and the weight gain that is associated with the use of an antipsychotic medication.
In view of these findings, the company is also planning a phase II trial with Eli Lilly to examine if OBE101 administered to patients in combination with the antipsychotic drug Zyprexa. The trial is expected to start in the spring of 2007.