OPKO strikes out with OPK-88004 for men with BPH

OPKO strikes out with OPK-88004 for men with BPH, shares down 25% premarket
Feb. 1, 2019 7:28 AM ET|About: OPKO Health, Inc. (OPK)|By: Douglas W. House, SA News Editor


OPKO Health (NYSEMKT:OPK) announces disappointing results from a Phase 2 clinical trial evaluating OPK-88004, a selective androgen receptor modulator (SARM), in men with benign prostatic hyperplasia (BPH) (enlarged prostate) and will suspend the study while the data are analyzed.

A preliminary review of the unblinded results showed that trans-rectal ultrasound was too imprecise to measure the drug's effect on prostate volume, one of the co-primary endpoints. Increases in liver enzymes were also noted (biomarkers for liver stress/damage) which returned to normal after treatment stopped. The analysis should be completed by next quarter.

The company is not giving up, though. It plans to conduct a Phase 2 study in prostate cancer patients who are receiving androgen deprivation therapy (ADT) and another Phase 2 in chronic kidney disease patients on hemodialysis who have low testosterone levels.

Shares are down 25% premarket on light volume.