Sophiris' prostate drug stages a Phase III comeback after a grim prognosis

Sophiris Bio's ($SPHS) treatment for enlarged prostate met its main goal in a Phase III trial after looking like a sure miss in a prior peek at results, rewarding the company's faith and setting the stage for a second late-stage study.

Sophiris CEO Randall Woods

The drug, PRX302, successfully reduced urinary tract symptoms of benign prostatic hyperplasia, or enlarged prostate, compared with placebo after a single treatment, the company said. In a 12-month study on 479 patients, Sophiris' drug charted a 7.6-point improvement from baseline on a measure of prostate symptoms, a statistically significant improvement over the 6.58-point benefit for patients who got only the delivery vehicle, the company said.

The drug missed a secondary goal of significantly improving urine flow, the company said, but met the endpoint of boosting patient-reported quality of life. On the safety side, 20.1% of patients in the PRX302 arm reported painful urination compared with 8.3% getting the vehicle, but the median duration of such discomfort was typically less than a day, Sophiris said. No patients withdrew from the trial over side effects, according to the company.

PRX302's Phase III success comes as a surprise after Sophiris' December disclosure of an interim analysis in which the company's independent advisers said the drug hadn't met its predefined threshold for efficacy at 12 weeks, casting doubts about the treatment's potential and lopping about 80% off of Sophiris' market cap.

The drug's reversal of fortune sent Sophiris' shares up nearly 170% on Tuesday as the company blueprints a second Phase III trial designed to prepare PRX302 for an FDA application.

Sophiris, formerly known as Protox, pulled off a $65 million IPO in 2013.

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