Combination of Agents in NEFROSIL™ found to be Highly Effective in Renal Disease Model

SCOTTSDALE, Ariz., June 2, 2015 /PRNewswire/ -- Prismic Pharmaceuticals Inc., a specialty pharmaceutical company developing FDA-approved prescription drugs and FDA-regulated medical foods, today announced the results of a study in an animal model of renal disease of the combination of ingredients in one of its lead products, NEFROSIL™, which is in development for Chronic Kidney Disease (CKD). NEFROSIL™ is a proprietary formulation of ultra-micronized palmitoylethanolamide combined with silymarin, a polyphenolic compound.  

The study was recently published in The European Journal of Pharmacology, and was conducted by Daniela Impellizzeri, Giuseppe Bruschetta, Akbar Ahmad, Rosalia Crupi, Rosalba Siracusa, Rosanna Di Paola, Irene Paterniti, Marco Prosdocimi, Emanuela Esposito, and Salvatore Cuzzocrea. The aim of the study, as noted by the authors, was to verify whether or not a combination treatment of palmitoylethanolamide and silymarin (Prismic's NEFROSIL™) "could exert more potent effects as compared to the single substances administered alone, allowing for administration of lower doses of the single agents in the treatment of renal disease. Thus, by reducing inflammation and by inhibiting oxidative stress, PEA + Silymarin treatment may reduce risk factors associated with the progression of renal diseases."

Based on the results achieved, the authors concluded that the results clearly demonstrated that palmitoylethanolamide combined with silymarin "attenuated the degree of renal inflammation," and also concluded that the combination "demonstrated both efficacy and safety in an animal model of kidney disease."

Commenting on behalf of the study sponsor, Prismic Pharmaceuticals, Dr. T. Forcht Dagi, MD, MPH, MBA, DMedSc, FAANS, FACS, FCCM, stated that, "It is important to note that Prismic's palmitoylethanolamide (PEA) has been extensively studied and its capability to reduce inflammatory processes and ischemia/reperfusion (I/R) damage in several validated animal models is well established. In this most recent study, the silymarin was shown to reduce kidney dysfunction, histological damage, neutrophil infiltration and oxidative stress in a dose dependent manner, and when combined with Prismic's proprietary formulation of palmitoylethanolamide, the therapy showed a pronounced synergistic or "potentiating" effect, significantly attenuating the degree of renal inflammation."

Prismic's CEO, Peter Moriarty, commented that, "This is another positive step in the development of NEFROSIL™.  Prismic looks forward to making NEFROSIL™ available to CKD patients as an FDA-regulated medical food in late 2016 following the successful completion of a human clinical study. The study will be conducted in patients with CKD and diabetes mellitus and will measure improvements in the albumin-creatinine ratios and reduction in proteinuria, and other markers associated with progression of CKD."

About Prismic Pharmaceuticals, Inc.
Prismic Pharmaceuticals, Inc. is a privately held specialty pharmaceutical company developing highly differentiated proprietary products in two distinct FDA categories, Prescription Drugs and Prescription Medical Foods, based on its two lead pharmaceutically active ingredients, ultra-micronized palmitoylethanolamide, and ultra-pure, high EPA, Omega-3. The company is developing products to address three key therapeutic areas with very large patient populations, and where there are clear and significant unmet clinical needs, namely, chronic kidney disease, depression, and severe chronic pain.Contact 480.422.1810 or visit www.PrismicPharma.com.

INFORMATION CONTACT
Peter J. Moriarty
Tel: 480.422.1810

SOURCE Prismic Pharmaceuticals, Inc.

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http://www.PrismicPharma.com