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.
"Unfortunately, the study results were disappointing but definitive," said Douglas Abel, president and chief executive officer of Manhattan Pharmaceuticals. "With all our development programs, Manhattan Pharmaceuticals is committed to the practice of excellent science and the highest standard of clinical research to ensure both accurate outcomes and patient safety. Based on positive preclinical data on OE, confirmatory results recently reported by Columbia University, and the Phase 1 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 2a trials, we believe it is the correct decision to discontinue our work with OE. These well designed Phase 2a trials produced quality data that permits us to make a clear cut decision at an early stage of the program."
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.
In keeping with this strategic focus, Manhattan Pharmaceuticals also announced today that it intends to pursue appropriate out-licensing opportunities for Propofol Lingual Spray for pre-procedural sedation.