Post Hoc Subgroup Analysis Reveals Statistically and Clinically Significant Weight Reduction Effect
RAMAT GAN, Israel--(BUSINESS WIRE)--Obecure Ltd. has announced the preliminary results of its Phase II clinical trial designed to evaluate the efficacy and safety of Histalean(TM) (formerly OBE101) for the treatment of obesity.
"The results suggest a strong gender and age effect and support the potential of the drug as a breakthrough anti-obesity agent in women 50 years old or less," said Dr. Yaffa Beck, Obecure's CEO.
The double-blinded placebo-controlled study included 281 patients, males and females aged 18-65, with a BMI ranging from 30 to 40. The study was conducted at 19 investigation sites across the U.S. Subjects were randomized into one of four groups comparing the safety and efficacy of 16 mg, 32mg, or 48mg daily doses of Histalean(TM) versus placebo, over the 12 week treatment period.
Top-line results showed that, although there was weight loss in many of the patients, there were no statistically significant differences among any of the treatment arms versus placebo. However, a post hoc segmentation analysis revealed an important finding regarding the effect of age and gender on drug response.
Analysis of the subpopulation consisting of females, aged 50 years or less, in the per protocol (PP) cohort, demonstrated a substantial difference between the mean weight loss in the high dose arm (48 mg/day) versus the placebo arm; the result showed a trend towards statistical significance (p=0.06 at 8 weeks and p=0.146 at 12 weeks).
The effect was even more pronounced when the analysis was limited to non-hispanic - women, 50 years old or younger. At the end of week 12, the 25 women on the 48 mg Histalean(TM) dose had lost an average of 2.61 Kg (2.91%) of their weight, versus 23 women on placebo, who lost only 0.4 Kg (0.43%) of their weight. This result was statistically significant with a p value of 0.003. The effect of ethnicity on drug responsiveness in the current analysis is still inconclusive, since the number of hispanic women in each study group was very small (4-5).
Another important finding was that the trajectory of weight loss in this high-Histalean(TM)-dose treated group continued over the entire study duration, up to and including the 12 week visit (see graph attached).
"We are excited by the robustness of the response to the 48 mg daily dose of Histalean(TM) in this subgroup of women under 50. Combined with the drug's remarkable safety profile, this positions Histalean(TM) as a contender in the greatly unmet market for anti-obesity drugs," said Dr. Yaffa Beck, Obecure's CEO. "The role of gender and age in Histalean's(TM) efficacy, will surely impact our future investigation of Histalean(TM) as a treatment for obesity, as well as for the prevention of weight gain induced by anti-psychotic drugs."
"The positive findings among this sub-group replicate the study results obtained in the previous pilot study carried out in a group of young obese women in Israel," said Dr. Nir Barak, Obecure's CSO. "This validates the neural histaminergic system as a target for development of a new drug class for weight management and indicates that by targeting this system, we may help patients reduce their weight."
According to the Center for Disease Control, about 32% of adult American women under 54 (about 25 million women) suffer from obesity.
There were no drug-related serious adverse events (SAEs) observed, and incidence of adverse events in the treatment arms were comparable to the incidence for patients in the placebo group. The only adverse event more common in the treatment group was headache (less than 10%). These observations extend the remarkable safety and tolerability profile of Histalean(TM) to obese patients.
"We are also very encouraged by the excellent safety results, which corroborate the historical safety record of this drug, which has been on the world market for about 40 years, as Betahistine - a treatment for vertigo," said Dr. Beck, adding that "we believe that this safety profile will enable further investigation of higher drug doses for obesity and other indications."
Obecure is also pursuing the use of Histalean(TM) for preventing the massive weight gain plaguing patients taking Zyprexa, a highly effective antipsychotic medication, with sales topping $4 billion annually.
Histalean(TM) is comprised of betahistine, approved and marketed worldwide, except in the United States, for the treatment of Meniere's disease (vertigo). Obecure is repurposing betahistine, which is an H1 receptor agonist and partial H3 receptor antagonist for the treatment of obese individuals and for other weight management indications. Betahistine has an excellent safety profile and has been used for treatment by more than 100 million patients suffering from vertigo and dizziness.
Founded in 2005, Obecure Ltd. is a biopharmaceutical company dedicated to the development of weight management drug therapies. The Company is currently pursuing the clinical development of its lead compound Histalean(TM) for general obesity and for weight gain associated with anti-psychotic drug therapy.
Obecure has a worldwide exclusive license from Mor Research Applications Ltd., the Technology Transfer Office of Clalit HMO to clinically develop and commercially exploit the technology, as developed by Dr. Nir Barak, a specialist in nutrition and internal medicine at the Rabin Medical Center in Tel Aviv.
Obecure is a subsidiary of Bio-Light Life Science Investments Ltd., an investment company, traded on the Tel Aviv Stock Exchange (TASE:BOLT).
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Yaffa Beck, CEO, +972-3-7534100
Source: Obecure Ltd.