Manhattan Pharmaceuticals to Discontinue Obesity Drug Program
Posted on: Tuesday, 10 July 2007, 12:22 CDT
Manhattan Pharmaceuticals is to discontinue its obesity drug program, based on results from two Phase IIa clinical trials for oral oleoyl-estrone which failed to demonstrate meaningful placebo adjusted weight loss.
The results of both randomized, double-blind, placebo-controlled studies, one in common obesity and the other in morbid obesity, demonstrated no statistically or clinically meaningful placebo adjusted weight loss for any of the treatment arms evaluated. Based on these results, Manhattan Pharmaceuticals will discontinue its OE programs in both types of obesity.
Both studies also showed dose-dependent increases in estrone and estradiol and concomitant suppression of testosterone. In addition, thyroid hormone changes were observed as well as changes in other hormones related to reproductive function. Despite these changes returning to baseline during off-therapy periods, they preclude exploration of higher doses of OE.
"Unfortunately, the study results were disappointing but definitive," said Douglas Abel, president and CEO of Manhattan Pharmaceuticals. "Based on positive preclinical data on OE, confirmatory results recently reported by Columbia University, and the Phase I clinical profile, we had been encouraged regarding the compound's potential as an effective weight loss agent. However, due to the findings from the two Phase IIa trials, we believe it is the correct decision to discontinue our work with OE."
Going forward, the company intends to continue with the advancement of its four clinical stage product candidates, and the exploration of other opportunities in the areas of dermatology/immunology and endocrine/metabolic disorders. The four clinical-stage product candidates include topical PTH (1-34) for psoriasis, as well as recently-acquired Altoderm for atopic dermatitis (eczema), Altolyn for mastocytosis, and Hedrin for head lice.
Source: Datamonitor
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