Company Intends to Move Compound into Late Stage Development
Top-line Data Expected in the Third Quarter of 2015
SAN DIEGO, June 15, 2015 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq: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."
About RayVa™
RayVa™ is the proprietary name for Apricus' product candidate for the treatment of Raynaud's phenomenon associated with scleroderma (systemic sclerosis). The RayVa product combines alprostadil (prostaglandin E1), a potent vasodilator, with Apricus' proprietary permeation enhancer, DDAIP.HCl, and is applied as an on-demand topical cream to affected extremities. RayVa may qualify for FDA priority review, given the unmet medical need and lack of approved products in the United States to treat secondary Raynaud's phenomenon in patients with systemic sclerosis. Apricus anticipates submitting a New Drug Application for RayVa as early as 2017.
About Raynaud's Phenomenon
Raynaud's phenomenon is characterized by vasoconstriction in response to cold or stress of the hands and feet, resulting in reduced blood flow and the sensation of pain, which can be severe. Primary Raynaud's phenomenon, which is not associated with an underlying medical condition, affects an estimated 3-5% of the US population.1,2 Secondary Raynaud's phenomenon, is driven by an underlying medical condition, such as scleroderma, lupus or rheumatoid arthritis.2 Symptoms are severe and patients risk associated fingertip ulcerations. There are an estimated 100,000 adult patients with scleroderma in the US3, of which approximately 90% have secondary Raynaud's phenomenon2. Approximately 80% of scleroderma patients are women.4 Both primary and secondary Raynaud's phenomenon disproportionately affects women.5 There is currently no approved therapy for Raynaud's phenomenon in the United States, representing an unmet medical need.
About Apricus Biosciences, Inc.
Apricus Biosciences, Inc. (APRI) is a biopharmaceutical company advancing innovative medicines in urology and rheumatology. Apricus' lead product, Vitaros®, for the treatment of erectile dysfunction, is approved in Europe and Canada and is being commercialized in several countries in Europe. Apricus' marketing partners for Vitaros include Mylan NV, Takeda Pharmaceuticals International GmbH, Hexal AG (Sandoz), Recordati Ireland Ltd. (Recordati S.p.A.), Bracco S.p.A. and Laboratoires Majorelle. Apricus' second-generation room temperature Vitaros is under development. Apricus has completed enrollment in a Phase 2a trial for RayVa™, its product candidate for the treatment of the circulatory disorder Raynaud's phenomenon. Additionally, Apricus has initiated a Phase 2 trial for fispemifene, a selective estrogen receptor modulator (SERM) for the treatment of symptomatic secondary hypogonadism in men, and plans to conduct additional studies in other urological conditions.
For further information on Apricus, visit http://www.apricusbio.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act, as amended. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things: the expected timing of top-line data for the Phase 2a clinical trial; Apricus' development activities following completion of the Phase 2a clinical trial, including potential guidance discussions with the FDA on a development pathway for RayVa and the potential to move RayVa into later stage clinical development; and the potential to receive priority review on RayVa and the potential timing of any NDA submission. Actual results could differ from those projected in any forward-looking statements due to a variety of reasons that are outside the control of Apricus, including, but not limited to: its ability to successfully complete the ongoing proof-of-concept study in a timely manner with results that warrant later-stage development of RayVa; feedback received from the FDA on the development of RayVa and, based on such feedback, further develop RayVa for the treatment of Raynaud's Phenomenon in patients with scleroderma, as well as the timing of such events; Apricus' ability to carry out further clinical studies for RayVa , as well as the timing and success of the results of such studies; Apricus' ability to raise additional funding that it may need to continue to pursue its commercial and business development plans; Apricus' ability to obtain the requisite governmental approval for RayVa; and market conditions. These forward-looking statements are made as of the date of this press release, and Apricus assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Readers are urged to read the risk factors set forth in Apricus' most recent annual report on Form 10-K, subsequent quarterly reports filed on Form 10-Q, and other filings made with the SEC. Copies of these reports are available from the SEC's website at www.sec.gov or without charge from Apricus.
References
1 N Engl J Med. 2002; 347:1001–1008.
2 Drugs 2007; 67: 517-525.
3 Curr Opin Rheumatol 2012, 24:165–170. American College of Rheumatology (http://www.rheumatology.org/Practice/Clinical/Patients/Diseases_And_Conditions/Scleroderma).
4 Medicine 2013; 92: 191-205.
5 National Institutes of Health
(http://www.nhlbi.nih.gov/health/health-topics/topics/raynaud/atrisk).