Promising profile of disease modification and pain reduction leads to proof of concept trials
Manhasset, NY – Molecular Medicine, a peer-reviewed biomedical journal published by the Feinstein Institute Press, published the results of a new study reporting clinically significant pain reduction in type 2 diabetic patients. In an exploratory study conducted by Araim Pharmaceuticals, a biotech company developing novel treatments for chronic diseases, investigators also observed improvements in metabolic control in patients administered ARA 290. ARA 290 is a peptide engineered to activate the innate repair receptor, a receptor discovered by Araim scientists, which is only expressed following tissue damage or stress.
In the initial study, patients were administered ARA 290, a novel, first-in-class drug, daily for 28 days, with the purpose of evaluating its efficacy in treating neuropathic pain, a common condition among diabetics. When ARA 290 is administered, the repair receptor is activated and subsequently turns off inflammation and turns on the body’s natural repair system. The short half-life of ARA 290, coupled with the restricted expression of the innate repair receptor, functions as a dual safety system to avoid potential side effects.
“The results from this study indicate a major breakthrough in the treatment of diabetes,” said Kevin J. Tracey, MD, president of the Feinstein Institute for Medical Research and Editor Emeritus of Molecular Medicine. “Over the years, Molecular Medicine has prided itself on publishing groundbreaking papers with implications on the broader medical community, and we’re proud to have a potential disease-modifying solution to diabetes featured in the current issue.”
The clinically significant results and excellent safety profile support Araim’s development strategy of two future studies in 2015. First, metabolic improvement will be studied in type 2 diabetics with moderate kidney damage. Second, neuropathic pain reduction will be assessed in a multi-center proof of concept trial in type 1 diabetics. Both phase 2 clinical trials will be conducted in the United Kingdom, and patients will be dosed daily for six months to allow time for adequate tissue repair.
“We’re excited to be on the cusp of the first diabetic disease modifier that demonstrates the potential to repair the complications of diabetes systemically,” said Anthony Cerami, PhD, CEO of Araim Pharmaceuticals.” Dr. Cerami developed the HbA1c diagnostic test, the current gold standard for diagnosing diabetes.
The research was supported in part by a grant from the Netherlands Institute for Regenerative Medicine. Read the full report in www.molmed.org.
About Araim Pharmaceuticals, Inc.
Araim Pharmaceuticals, Inc. is a privately held biotech company founded in 2006 engaged in developing novel treatments for devastating injuries and chronic diseases underserved by current therapies. Their lead compound, ARA 290, is a novel 11 amino acid peptide engineered to specifically activate the body’s natural repair system via the innate repair receptor that is present only following injury. ARA 290 activates anti-inflammatory, tissue protective, and reparative signaling pathways. The short half-life of ARA 290 coupled with the restricted expression of the innate repair receptor functions as a dual safety system to avoid potential side effects. Clinical trials evaluating ARA 290 for treatment of neuropathic symptoms associated with diabetes and the orphan disease sarcoidosis are currently ongoing in the US and Europe. ARA 290 has received orphan drug designation in the US and in Europe, as well as Fast Track designation in the US for treatment of small fiber neuropathy in sarcoidosis. For more information, visit www.araimpharma.com.
About Molecular Medicine
Molecular Medicine is an open access, international, peer-reviewed biomedical journal published by the Feinstein Institute Press. Molecular Medicine strives to understand normal body functioning and disease pathogenesis at the molecular level, which may allow researchers and physician-scientists to use that knowledge in the design of specific molecular tools for disease diagnosis, treatment, prognosis, and prevention. To learn more, visit www.molmed.org.
About The Feinstein Institute for Medical Research
Headquartered in Manhasset, NY, The Feinstein Institute for Medical Research is home to international scientific leaders in many areas including Parkinson’s disease, Alzheimer’s disease, psychiatric disorders, rheumatoid arthritis, lupus, sepsis, human genetics, pulmonary hypertension, leukemia, neuroimmunology, and medicinal chemistry. The Feinstein Institute, part of the North Shore-LIJ Health System, ranks in the top 6th percentile of all National Institutes of Health grants awarded to research centers. For more information, visit www.FeinsteinInstitute.org.
Terry Lynam, Vice President of Public Relations