FLEMINGTON N.J., Oct. 29, 2015 (GLOBE NEWSWIRE) — Arno Therapeutics, Inc. (OTCQB:ARNI), a clinical stage biopharmaceutical company primarily focused on the development of therapeutics for cancer and other life threatening diseases, today announced data demonstrating that AR-12 is a promising novel antifungal agent for the treatment of onychomycosis, a common fungal infection of the fingernails and toenails, with activity against two primary fungal organisms responsible for causing the condition. Results will be presented in a poster presentation, titled “Trans-ungual Delivery of AR-12, a Novel Antifungal Drug” (Poster R6046), on Thursday, October 29 during the 2015 American Association of Pharmaceutical Scientists Annual Meeting and Exposition, being held in Orlando, FL.
Stefan Proniuk, Ph.D., Chief Development Officer of Arno Therapeutics, commented, “Onychomycosis is an infection that leads to thickened, discolored and split nails and that has increasing prevalence in the U.S. – currently affecting approximately 10% of the general population1 and resulting in a growing need for more effective drugs for improving the success rate and decreasing the required duration of topical therapy. The effectiveness of current topical therapies on the market may in part be limited due to the poor permeability of the nail plate to topically-applied therapeutic agents. AR-12 has been found to penetrate the nail bed and to be highly potent against Trichophyton rubrum fungus which is predominantly responsible for causing onychomycosis. While early, these findings indicate that AR-12 may have substantial clinical potential as a new drug candidate for treating onychomycosis as a result of its ability to penetrate across the nail plate. The results of this study provide a strong rationale for further development. Furthermore, we are pleased that AR-12 has demonstrated its potential versatility in yet another infectious disease.”
Findings, from a team of various collaborators, demonstrated that AR-12 is able to penetrate across the human nail plate in significant amounts, which can be further improved with the use of identified permeation enhancers. The study found that the amount of AR-12 permeated across the human nail plate after one week was 0.82±0.11 ng/cm2, and the amount of drug retained in active diffusion area of the nail plate was ~0.42±0.02 µg/mg.
In addition, the study demonstrated that two common permeation enhancers, PEG-400 (polyethylene glycol 400, a low-molecular-weight grade) and dexpanthenol, have the potential to powerfully enhance the trans-ungual delivery of AR-12. In vitro permeation studies showed the amount of AR-12 permeated across the nail plate after application of combination formulation containing dexpanthenol and PEG 400 was found to be ~5.6 and 5.2 fold more than control. The combination of both enhancers together did not lead to any additive or synergistic enhancement in permeation of AR-12. The amount of AR-12 retained in the nail plate in formulations containing dexpanthenol and PEG 400 was found to be ~1.6 and 1.7 fold more relative to control. The amount of AR-12 in the peripheral nail plate was enhanced by 3.0 and 3.7 folds respectively. The combination enhanced the retention up to 2.1 and 3.4 folds more than control in the active diffusion area and peripheral region on the nail plate.
Date of article/Start date of trial: 15 July 2016