Promising profile of disease modification and pain reduction leads to proof of concept trials
Results of a new study published in the journal Molecular Medicine, a peer-reviewed biomedical journal published by the Feinstein Institute Press, report 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 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.
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Michael Brines, Ann N. Dunne, Monique van Velzen, Paolo L. Proto, Claes-Goran Ostenson, Rita I. Kirk, Ioannis Petropoulos, Saad Javed, Rayaz A. Malik, Anthony Cerami, Albert Dahan. ARA 290, a non-erythropoietic peptide engineered from erythropoietin, improves metabolic control and neuropathic symptoms in patients with type 2 diabetes. Molecular Medicine, Published Online November 6, 2014. doi: 10.2119/molmed.2014.00215