Arcion Therapeutics, a venture backed clinical stage biotechnology company developing topical therapies for chronic pain, announced top-line results from a successful Phase 2b double-blind, randomized, placebo-controlled clinical trial of its lead topical pain candidate, ARC-4558, in adult patients with painful diabetic neuropathy (PDN). Arcion recently held an End of Phase 2 meeting with the United States Food and Drug Administration (FDA) and the ARC-4558 program is now poised to enter Phase 3 studies. ARC-4558 is a 0.1% gel formulation of clonidine hydrochloride for topical administration.

The study results successfully demonstrated therapeutic potential for treating PDN with ARC-4558 by targeting abnormal nerve signaling at the level of the skin with a 0.1% topical gel formulation of clonidine. ARC-4558 was most effective in reducing pain in subjects with evidence of preserved nociceptors (nerve fibers responsible for pain signaling) in the skin. In subjects with at least minimal nociceptor function, ARC-4558 was significantly more effective in reducing pain than placebo (p