Opko Health Inc. (NASDAQ:OPK) reported that the firm has registered the first patient in a Phase IIb dose ranging study of OPK88004, its orally administered SARM, to cure men with enlarged prostate or benign prostatic hypertrophy. BPH 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 identify appropriate doses administered over a 4-month treatment period to lower prostate size, the main efficacy endpoint of the trial. The trial will also evaluate secondary endpoints, including blood PSA levels and body composition parameters.
Interest in assessing OPK88004 as a cure for BPH is grounded on data from a 12-week trial of 350 men who demonstrated significantly lowered fat mass, increased muscle strength and increased lean body mass without considerably altering PSA levels in the overall population, while lowering PSA levels in men with higher PSA levels.
The antagonistic and selective properties of OPK88004 seem to be well suited to potentially 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%. Phillip Frost, M.D., the CEO and Chairman of Opko Health, expressed that they are delighted to be starting this trial in patients suffering from BPH, as there are not enough treatment alternatives for this common debilitating problem that affects men as they age.
They consider that OPK88004 has the prospect of showing a new standard of care for an ailment that impacts millions of men globally. Provided the large count of patients with BPH, the company anticipate to complete the trial and to have topline data before the close of 2018.
In the last trading session, the stock price of Opko gained more than 1% to close the day at $5.08.