Obecure obesity drug shows strong results in women

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 US. Subjects were randomized into one of four groups comparing the safety and efficacy of 16mg, 32mg, or 48mg daily doses of Histalean 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 (48mg/day) versus the placebo arm; the result showed a trend towards statistical significance.

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 48mg Histalean dose had lost an average of 2.61kg (2.91%) of their weight, versus 23 women on placebo, who lost only 0.4kg (0.43%) of their weight. 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).

“We are excited by the robustness of the response to the 48 mg daily dose of Histalean in this subgroup of women under 50. Combined with the drug’s remarkable safety profile, this positions Histalean 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 efficacy, will surely impact our future investigation of Histalean as a treatment for obesity, as well as for the prevention of weight gain induced by anti-psychotic drugs.”