BALTIMORE, July 20 /PRNewswire/ — Arcion
Therapeutics, a venture backed clinical stage biotechnology
company developing topical therapies for chronic pain, today
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
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<0.05). The significance of the response increased with higher
levels of nociceptors in the subject’s skin (p<0.005).
ARC-4558 did not demonstrate efficacy in subjects lacking
evidence of preserved nociceptor function.
The ITT (intent to treat) population was comprised of a mix of
subjects in which about half had little or no nociceptor
preservation and therefore the pooled results were not significant.
Plasma levels of clonidine were consistently