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 to treat clinical indications where patients experience frailty, decreased bone and quality of life parameters due to low endogenous testosterone, or by lowering of testosterone therapeutically such as Androgen Deprivation Therapy. The selective anabolic effects of SARM increase their potential use over currently available androgen receptor ligands in aging males suffering symptoms from decreased endogenous testosterone levels.
We are planning a phase 2 clinical study to assess the feasibility of OPK88004 in prostate cancer patients suffering of frailty, bone loss and decreased quality of life from treatment with Androgen Deprivation Therapy (ADT). ADT results in the reduction of testosterone to castration levels in men with prostate cancer. 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 quality of life 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 quality of life of prostate cancer patients.
Because of OPK88004's significant increase of muscle mass (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.