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Apricus Reports Top-Line Phase 2a Data for RayVa(TM), Its Topical Treatment for Raynaud's Phenomenon
Apricus Reaffirms Plans to Move RayVa Into Late-Stage Clinical Trials in Patients With Scleroderma Who Also Suffer From Raynaud's Phenomenon

SAN DIEGO, Sept. 17, 2015 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced top-line results from the RayVa Phase 2a trial in patients with scleroderma who also suffer from Raynaud's phenomenon ("Raynaud's"). The primary objective of this clinical trial was to establish safety and tolerability and to look for pharmacodynamic effects in this targeted Raynaud's population. The RayVa Phase 2a trial was a randomized, double-blind, placebo-controlled trial that enrolled approximately thirty-five subjects across four U.S. sites. The clinical trial was based on an experimental design wherein subjects were exposed to a cold challenge to assess blood flow (hemodynamic) and skin temperature (thermodynamic) changes, by laser Doppler and thermography, as a result of the vasoconstriction characteristic of Raynaud's. In each case, subjects were exposed to a dose of placebo and a dose of one of three active doses, and served as their own control.

Importantly, there were no significant safety or tolerability issues observed in any dosing cohort. Moreover, while this exploratory study was not designed or powered to show a statistically significant pharmacodynamics result, there were subjects who demonstrated improvements in blood flow and/or hand temperature across all dosing cohorts. Apricus believes that this data, coupled with previously generated non-clinical data, supports moving RayVa forward into future clinical trials designed to evaluate symptomatic effects in subjects with Raynaud's secondary to scleroderma.

"This clinical trial was an important step for the company, and one in which the company acquired additional pharmacodynamic data that will help inform the future development of the product candidate. As this was the first in human study in this patient population, we are pleased to have confirmed safety and tolerability, as well as improvements in blood flow and skin temperature in certain subjects. The next steps will be to continue formulation development activities for at-home dosing, and complete study planning for our future clinical trials," said Barbara Troupin, MD, Chief Medical Officer of Apricus. "Looking forward, we will move RayVa into later-stage clinical trials designed to address the symptoms of an acute Raynaud's attack, which is an important regulatory endpoint for this indication, as well as a clinically meaningful outcome for patients who suffer from this debilitating disease." 

"This patient population has been without meaningful treatment options to address the acute symptoms of Raynaud's, which can include pain and functional limitations in the hands and feet, impairing work and family time," said Dr. Elena Schiopu, Professor of Rheumatology at the University of Michigan in Ann Arbor. "As the lead investigator for this exploratory study, I was very pleased with the insights we have gained about this novel compound and how well it was tolerated by my patients, and I look forward to working with Apricus on future clinical trials to address this unmet medical need."

Apricus intends to move RayVa into a later stage Phase 2 clinical trial in 2016. This clinical trial will be designed to assess safety and efficacy in an at-home dosing setting evaluating a symptomatic response to the treatment of an acute episode. To accomplish this, Apricus will complete development of the clinical protocol for at-home dosing, finalize the RayVa formulation and delivery system, and complete manufacturing of clinical trial materials.  

About Raynaud's Phenomenon

Raynaud's phenomenon is characterized by vasoconstriction of the hands and feet in response to cold or stress 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 U.S. population.1,2 Secondary Raynaud's phenomenon is driven by an underlying medical condition, such as scleroderma, lupus or rheumatoid arthritis.2 Symptoms may be severe and patients risk associated fingertip ulcerations. There are about 75,000 to 100,000 adult patients with scleroderma in the U.S.,3 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 has initiated a Phase 2b trial for fispemifene, a selective estrogen receptor modulator for the treatment of symptomatic male secondary hypogonadism, and plans to conduct additional studies in other urological conditions. Apricus has completed a Phase 2a trial for RayVa, its product candidate for the treatment of the circulatory disorder Raynaud's phenomenon, and plans to conduct additional clinical trials in patients with Raynaud's phenomenon secondary to scleroderma. Apricus' lead commercial product, Vitaros®/™, for the treatment of erectile dysfunction, is approved in Europe and Canada and is being commercialized in several countries in Europe. Apricus recently in-licensed the U.S. development and commercialization rights for Vitaros from Allergan. Apricus' European marketing partners for Vitaros include Laboratoires Majorelle, Bracco S.p.A., Hexal AG (Sandoz), Takeda Pharmaceuticals International GmbH and Recordati Ireland Ltd. (Recordati S.p.A.). Apricus' second-generation room temperature Vitaros is currently under development.

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: Apricus' development activities for RayVa, including a development pathway and its ability to move RayVa into later stage clinical development; the timing and results of future studies and clinical trials in any of Apricus' product candidates; the size of the patient population suffering from primary or secondary Raynaud's phenomenon; and the potential timing of any new drug application, or 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 receive feedback 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/I-Am-A/Patient-Caregiver/Diseases-Conditions/Scleroderma).
4 Medicine 2013; 92: 191-205.
5 National Institutes of Health (http://www.nhlbi.nih.gov/health/health-topics/topics/raynaud/atrisk).

CONTACT: Matthew Beck
         mbeck@troutgroup.com
         The Trout Group LLC
         (646) 378-2933

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