Prismic has two pharmaceutically active ingredients, ultra-micronized palmitoylethanolamide, and ultra-pure EPA-based Omega-3, both of which have significant potential in benefiting patients with conditions where there is a significant unmet medical need. These diseases include Chronic Kidney Disease, depression, and pain. We plan to develop proprietary products utilizing these active pharmaceutical ingredients in two distinct FDA categories, prescription Medical Foods and Prescription Drugs.
Chronic Kidney Disease (CKD)
CKD affects an estimated 27 million people in the United States. According to a recent publication in the American Journal of Kidney Disease, the prevalence of CKD in adults 30 years or older is projected to increase from 13.2% currently to 14.4% in 2020 and 16.7% in 2030. Diabetes, which affects 29 million Americans, is the leading cause of CKD with 1 out of 3 diabetics also having CKD. Other risk factors for CKD include high blood pressure, cardiovascular disease, obesity, and high cholesterol amongst others.
Prismic plans on completing two clinical studies in 2016 to support the introduction of NEFROGESIC™ (palmitoylethanolamide) and NEFROSIL™ (palmitoylethanolamide and silymarin). The primary end-point in the NEFROGESIC™ study will be to demonstrate improvements in biomarkers associated with pain and inflammation, while concurrently establishing that the product is renal-friendly (does not damage the kidneys). The NEFROSIL™ study is designed to demonstrate positive improvements in biomarkers associated with the progression of kidney disease, including improvements in the albumin-creatinine ratio and reduction in proteinuria.
Over 22 million Americans suffer from depression. NEUREPA® (92% EPA, Omega-3 in triglyceride form) is a prescription medical food that has been developed for the clinical dietary management of depression and Bipolar Disorder (depressive phase). NEUREPA® is market-ready for commercialization.
The third area of focus relates to chronic pain, a condition that affects 100 million Americans. Recent data indicates that palmitoylethanolamide may have both a solo mechanism of action and a “potentiating” or “synergistic” effect when combined with narcotics and certain other drugs used for the treatment of severe chronic pain. Prismic plans to undertake proof-of-concept clinical studies to demonstrate the “potentiating” effect of our formulation of palmitoylethanolamide when administered concomitantly with drugs such as morphine, oxycodone, hydrocodone, and pregabalin. The studies will assess the effect of concomitant administration of palmitoylethanolamide in terms of “potentiating” (enhancing) the effectiveness of these drugs, allowing for lower doses of the drugs to be used while achieving the desired therapeutic effect. Such results would also be expected to demonstrate a consequent lessening or avoidance of adverse events/side effects and, in the case of opiates/narcotics, potentially, a delay in the onset of tolerance development.
Prismic is headquartered in Scottsdale, Arizona, USA.
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Prismic Pharmaceuticals, Inc.
Attn: Zachary Dutton
95 Prescott Street
Worcester, Massachusetts 01605