Transition Therapeutics (Transition) has dosed the first patient in a Phase ll trial of its selective androgen receptor modulator (SARM) drug candidate TT701.
The study will assess the efficacy and safety of TT701 in improving the symptoms of androgen deficiency, including sexual symptoms, fatigue / low vitality, and physical dysfunction in men with prostate cancer who have undergone radical prostatectomy for organ-localised prostate cancer.
The Phase ll clinical trial is being conducted at Brigham and Women's Hospital (BWH), US, led by principal investigator Dr Shalender Bhasin from BWH and will enrol up to 125 subjects at selected specialised clinical sites including BWH.
BWH research programme in men's health: aging and metabolism director Shalender Bhasin said: "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 localised disease.
"Therefore, the ability to treat these symptoms safely is an important unmet need."
The company stated that its wholly-owned subsidiary, Transition Therapeutics Ireland has exclusively licensed worldwide rights to the TT701 drug candidate from Eli Lilly and Company (Lilly).
The dosing of the first patient in this study is expected to generate a payment of $500,000 to Lilly.
Transition further noted that prostate cancer is the most common malignancy in American men, accounting for 29% of all diagnosed cancers and around 13% of all cancer deaths.
Its incidence is on the rise, partly due to increased screening with Prostate-specific antigen (PSA).
The majority of these men have low-grade, organ-confined prostate cancer and good prospects of long-term survival.