Apricus Biosciences Announces Last Patient Enrolled in RayVa Phase 2a Clinical Trial for Raynaud's Phenomenon in Patients With Scleroderma

Apricus Biosciences, Inc. APRI, a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced that it has enrolled the last patient in its RayVa™ Phase 2a proof-of-concept study. The Company expects to report top-line data in the third quarter of 2015 in advance of potentially moving RayVa into a pivotal Phase 2b trial following further guidance discussions with the FDA. The compound is being studied at four US sites in a Phase 2a proof-of-concept study in patients with scleroderma who also suffer from Raynaud's Phenomenon. RayVa is an internally developed, globally-owned compound consisting of alprostadil in a DDAIP.HCl permeation enhancer. This study is designed with a cold challenge meant to induce a Raynaud's episode followed by an assessment of the safety and tolerability, the effect of study medication on hand temperature and heat distribution based on thermography, and hemodynamic changes measured by laser doppler. The study is assessing three doses of RayVa plus placebo in a crossover design, where each subject receives one of three doses of study medication and a dose of placebo, thus serving as their own control. Apricus initiated a Data Monitoring Committee (DMC) in the first quarter of this year to assist in the prospective assessment of safety, tolerability and overall benefit to risk. To date, there have been no safety or tolerability concerns evident from the Company's review of blinded data or changes to the course of the study recommended by the DMC. Following the last patient visit, the Company will close and lock the database, complete an analysis of the final data, optimize the formulation required for future pivotal studies, and prepare the protocols for Phase 2b and 3 studies. Once the final data is available and study designs are completed, Apricus intends to seek advice from the FDA regarding the scope of the development program through to the NDA filing. "Apricus is seeking to accelerate our move into a more "real world setting", by advancing RayVa into later phase development. The subsequent studies will be based on at-home, on-demand treatment of spontaneous Raynaud's episodes, and will further assess safety, tolerability and efficacy of one or more doses," said Barbara Troupin, MD, Chief Medical Officer of Apricus Biosciences. "Further, with no current acute treatment options for Raynaud's Phenomenon in this patient population, Apricus is eager to move the compound forward in the clinic in an effort to provide relief for patients suffering from this debilitating condition."