Opko Health Inc. (NASDAQ:OPK) has enrolled the first subject in a Phase IIb dose ranging study of OPK88004, its orally given selective androgen receptor modulator, to treat men struggling from benign prostatic hypertrophy or enlarged prostate. BPH marks as a non-cancerous problem in which an enlarged prostate tissue forces against the bladder and the urethra, limiting the urine flow. This disease affects around 50 million men in the United States.
Opko reported that this study will register around 125 men with BPH at 30 locations in the United States to know appropriate doses administered over a 4-month treatment period to lower prostate size, the main efficacy objective of the trial. The study will also evaluate secondary objectives, including blood PSA levels and body composition parameters like fat mass and lean body mass.
Interest in assessing OPK88004 as a cure for BPH is grounded on data from a 12-week trial of 350 men who demonstrated notably decreased fat mass, increased muscle strength and increased lean body mass without considerably affecting PSA levels in the population, while lowering PSA levels in men with higher PSA levels.
The antagonistic and selective properties of OPK88004 seem to be well suited to prospectively lower prostate hypertrophy in BPH patients, while offering anabolic benefits like increased muscle strength and lean body mass. In previously performed dog trials, treatment with OPK88004 for six months lowered prostate weight by up to 75%, showcasing the strong antagonistic effects of “OPK8004” on androgen receptor movement in the prostate.
Phillip Frost, M.D., the CEO and Chairman of Opko Health, expressed that they are thrilled to be commencing this study in men struggling from BPH, as there are no sufficient treatment alternatives for this common debilitating problem that affects men. They consider that OPK88004 possess the potential of launching a new standard of care for an ailment that impacts millions of men worldwide.