ARC-4558 Demonstrates Pain Reduction In Phase 2b Trial For PDN: Arcion

Arcion said that ARC-4558 is a 0.1% gel formulation of clonidine hydrochloride for topical administration.

ARC-4558 Phase 2b study showed the 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.

In the trial, 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 more effective in reducing pain than placebo.

Reportedly, the significance of the response increased with higher levels of nociceptors in the subject’s skin. ARC-4558 did not demonstrate efficacy in subjects lacking evidence of preserved nociceptor function.

James Campbell, president and CEO of Arcion, said: “The data reported today for ARC-4558 provide support for Arcion’s fundamental approach of applying therapies topically to relieve neuropathic pain by targeting nerve signaling at the level of the skin.

“Through this study, we identified a simple, predictive clinical test to identify non-responders to ARC-4558, which should enable us to optimise subject enrollment in future studies.

“Based on our successful End of Phase 2 meeting with the FDA, we believe ARC-4558 is expected to be the first PDN treatment indicated to treat patients who have demonstrable functional nociceptors in the skin.”

Following an End of Phase 2 meeting with the FDA Arcion is now poised to initiate the Phase 3 studies of the ARC-4558.