Targeting the androgen receptor with our non-steroidal SARM
Enobosarm has been evaluated as a hormonal therapy for women with estrogen receptor positive (ER+) and androgen receptor positive (AR+) breast cancer in a Phase 2 clinical trial for this advanced breast cancer population. In two dose cohorts (9 mg and 18 mg), the Phase 2 trial pre-specified threshold for success, clinical benefit response (CBR), was attained meeting the trial’s primary efficacy endpoint. The trial enrolled the predefined number of evaluable patients in both dosage arms with at least 44 patients in each of two cohorts receiving 9 mg or 18 mg daily doses of enobosarm.
After evaluating the drug development environment for breast cancer, where treatment paradigms are shifting to immunotherapies and/or combination therapies, the Company has decided that the time and cost of conducting the necessary clinical trials for approval in this indication does not warrant further development of enobosarm in this indication at this time.