Selective Androgen Receptor Modulators (SARMs) have recently garnered attention as possible therapeutic agents due to their increased specificity for anabolic androgen receptors, and yet potentially serving as an antagonist to androgen receptors in the prostate. OPK88004 is being assessed as a treatment for muscle wasting, decreased physical strength and function, sarcopenia, and frailty in end stage renal disease (ESRD) patients on dialysis and for prostate cancer patients on Androgen Deprivation Therapy (ADT). The selective anabolic effects of SARM on lean body mass and physical function should provide advantages over other therapies with potential effects on the prostate in aging males.
We are planning phase 2 clinical studies to assess the feasibility of OPK88004 to treat muscle wasting, decreased physical strength and function, sarcopenia, frailty and associated poor quality of life parameters in two potential patient populations: 1) End ESRD patients on dialysis with low testosterone levels, and 2) prostate cancer patients undergoing Androgen Deprivation Treatment reducing endogenous testosterone to castration levels.
End Stage Renal Disease patients on dialysis treatment suffer from muscle wasting, decreased physical function, frailty and a poor quality of life. ESRD patients who have lower testosterone levels have increased incidence of muscle wasting and frailty. Because of OPK88004's significant increase of LBM and strength, and because of our strong interest in the therapy of chronic kidney disease (CKD) patients, another phase 2 trial is planned to treat kidney dialysis patients who have low testosterone levels and commonly suffer from muscle weakness and general frailty. Approximately 500,000 CKD patients are on dialysis therapy in the U.S.
ADT is an effective treatment for prostate cancer by reducing testosterone to castration levels in men. In addition, ADT is associated with side effects such as decreased lean body mass (LBM), physical function, bone quality and increases in body fat, frailty, and hot flashes. The diminished QoL results in approximately one-third of men treated with ADT stopping treatment within six months of initiation. Our trial data in aging men indicate that OPK88004 increases LBM decreases fat and increases physical function. Because OPK88004 decreases PSA levels due to its antagonistic effects on the prostate, it may be well-suited to treat men on ADT therapy. The contemplated phase 2 study is designed to show that OPK88004 improves ADT-associated symptoms and QoL of prostate cancer patients.