Biopharmaceutical company Apricus Biosciences, Inc. announced it has successfully enrolled the first patient for a Phase 2a clinical trial for RayVa™, the company’s frontline candidate for scleroderma-related Raynaud’s phenomenon. Scleroderma, classified among autoimmune rheumatic diseases, causes hardening or spontaneous scarring of the skin, internal organs, and blood vessels. One of its hallmarks is Raynaud’s phenomenon, which according to Dr. James R. Seibold, a globally recognized researcher in both scleroderma and Raynaud’s phenomenon and the Principal Member of Scleroderma Research Consultants, LLC, manifests as pain, loss of function in the hands, and ulcerations in the fingertips due to the significant reduction in capillary blood flow to the fingers secondary to blood vessel hardening.
RayVa™ is a topical, combined formulation of alprostadil, a potent vasodilator, and the company’s patented permeation enhancer, DDAIP.HCl. This on-demand ointment has shown the ability to increase blood flow locally, and can potentially reduce symptoms of Raynaud’s and subsequent digital injuries. The RayVa™’s Phase 2a clinical study aims to enroll at least 45 patients with active Raynaud’s phenomenon caused by scleroderma, and will evaluate the product’s effect on hemodynamics, skin temperature at the area of application, and symptomatic response to a standardized cold challenge. The clinical trial is randomized, double-blind, placebo-controlled, and features a crossover design, wherein participants will be given a placebo and one of three varying doses of the product.
According to the company’s chief executive officer Rich Pascoe, the successful enrolment and dosing of the first patient for the Phase 2a RayVa trial is as much a milestone for Apricus as it is for the scleroderma community. The company is also set to launch a Phase 2b clinical trial for fispemifene within the first half of 2015, indicated for men with secondary hypogonadism, which coupled with the ongoing studies for RayVa should place Apricus’ pipeline portfolio in a solid position for further advancements and investments.
In addition to spurring on Raynaud’s phenomenon, Scleroderma can also affect the gastrointestinal tract, which is why the Federal University of Sao Paulo recently launched a Phase 3 clinical trial entitled, “Effects of Probiotics on Gastrointestinal Symptoms and on the Immune System in Patients With Systemic Sclerosis: a Randomized Double-blind Placebo-controlled Clinical Trial,” that aims to further evaluate the benefits of probiotics in patients with systemic scleroderma that has spread to the GI tract. Patient enrolment begins this December 2014. For more information, visit www.clinicaltrials.gov.