Transition Therapeutics begins Phase 2 SARM study

Transition Therapeutics (NASDAQ:TTHI, TSX:TTH) has dosed the first patient in a Phase 2 study of selective androgen receptor modulator (SARM) drug candidate, TT701.

The Phase 2 study will evaluate the efficacy and safety of TT701 in improving the symptoms of androgen deficiency, including sexual symptoms, fatigue/low vitality, and physical dysfunction in men who have undergone radical prostatectomy for organ-localized prostate cancer.

Brigham and Women’s Hospital (BWH) is conducting the investigator-led Phase 2 clinical study, which is expected to enroll up to 125 subjects at selected specialized clinical sites, including BWH.

“Sexual dysfunction, fatigue and other distressing symptoms of testosterone deficiency can greatly reduce the quality of life for men who have undergone radical prostatectomy for organ localized disease,” said Dr. Shalender Bhasin, the trial’s principal investigator and an internationally recognized endocrinologist with expertise in testosterone biology and men’s aging.

Dr. Tony Cruz, chairman and CEO of Transition, said working closely with BWH and Dr. Bhasin has been instrumental in advancing TT701 as a therapeutic to address the challenging symptoms associated with radical prostatectomy procedures. “The properties of TT701 may provide these men an improved quality of life,” he added.

Transition’s wholly-owned subsidiary, Transition Therapeutics Ireland, exclusively licensed worldwide rights to the TT701 drug candidate from Eli Lilly. Dosing the first patient in the study will trigger a $500,000 milestone payment to Eli Lilly.