Shares of Apricus Biosciences, Inc. APRI plunged 47.2% after the company revealed disappointing top-line results from a phase IIb proof-of-concept study on fispemifene, which showed that the candidate had failed to achieve statistical significance in key clinical benefit endpoints.
Fispemifene was being evaluated for the treatment of men with secondary hypogonadism and sexual dysfunction.
The randomized, double-blind, placebo-controlled study evaluated the safety, tolerability and ability of the candidate in improving sexual function outcomes of erectile function and low libido in men (n~160) with secondary hypogonadism compared to placebo.
While data from the study revealed statistically significant improvements in testosterone levels, over the placebo arm, the magnitude of this increase was, however, not sufficient to achieve statistical significance for either the erectile function (primary endpoint) or the low libido (secondary endpoint). On the other hand, the candidate was generally well tolerated, with no new or significant safety issues arising from the study.
Consequently, Apricus reported that it will discontinue the development of fispemifene for the treatment of symptomatic secondary hypogonadism.
Meanwhile, Apricus said that it will now focus on the other candidates in its pipeline, such as RayVa, in a phase II study for the treatment of Raynaud’s phenomenon, secondary to scleroderma. In addition, the company expects to resubmit a revised regulatory application for its erectile dysfunction drug, Vitaros, in the U.S. in the third quarter of the year. Moreover, the company expects to focus on boosting Vitaros sales in the ex-U.S. market.
Apricus currently has a Zacks Rank #2 (Buy). Other favorably placed stocks in the health care sector include AMAG Pharmaceuticals, Inc. AMAG, Repros Therapeutics Inc. RPRX and Emergent BioSolutions, Inc. EBS, each sporting a Zacks Rank #1 (Strong Buy).
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