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Novel Agent Decreases Neuropathic Pain in Patients With Type-2 Diabetes
The results of a new study reporting clinically significant pain reduction in patients with type-2 diabetes have been published in Molecular Medicine. The authors also observed improvements in metabolic control in patients administered ARA 290, a peptide engineered to activate the innate repair receptor, which is expressed only after tissue damage or stress.
In the new study, patients received ARA 290 daily for 28 days, with the objective of evaluating the drug’s efficacy in treating neuropathic pain, a common condition in diabetics.
According to the compound’s developer (Araim Pharmaceuticals), 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 adverse 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.
The promising findings support plans to conduct two additional studies in 2015. First, metabolic improvement will be evaluated in patients with type-2 diabetes and moderate kidney damage. Second, the reduction of neuropathic pain will be assessed in a multicenter proof-of- concept trial in patients with type-1 diabetes. Both phase II studies will be conducted in the United Kingdom, and patients will be dosed daily for 6 months to allow time for adequate tissue repair.
ARA 290 is an 11-amino-acid peptide engineered to activate the body’s natural repair system via the innate repair receptor, which is present only after injury. ARA 290 activates anti-inflammatory, tissue-protective, and tissue-reparative signaling pathways. The compound’s short half-life, coupled with the restricted expression of the innate repair receptor, functions as a dual safety system to avoid potential adverse effects, according to Araim.
Clinical trials evaluating ARA 290 for the treatment of neuropathic symptoms associated with diabetes and the orphan disease sarcoidosis are being conducted in the U.S. and Europe. In the U.S., ARA 290 received an “orphan drug” designation as well as “fast track” status for the treatment of small-fiber neuropathy in sarcoidosis.
Sources: North Shore–LIJ; December 15, 2014; and Molecular Medicine; November 6, 2014.