Phase 2a Studies For Oral Oleoyl-Estrone Failed
Manhattan Pharmaceuticals announced negative results of the company's two Phase 2a clinical trials of oral Oleoyl-estrone (OE).
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 common obesity and morbid 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 (i.e., FSH, LH, prolactin, sex hormone binding globulin). Despite these changes returning to baseline during off therapy periods they preclude exploration of higher doses of OE.