Daewoong Pharmaceutical said Tuesday that its U.S. partner, AEON Biopharma, has confirmed the safety and efficacy of Daewoong's botulinum toxin (BTX), ABP-450, through phase 2 clinical trials in cervical dystonia and preclinical results in post-traumatic stress disorder (PTSD).

AEON Biopharma, a U.S. botulinum toxin company, became Daewoong's partner for the launch of BTX products in the U.S. in 2019 and is currently conducting clinical trials of ABP-450 for therapeutic indications in the U.S.

AEON Biopharma presented results from an open-label extension study of its phase 2 clinical trial of ABP-450 in patients with cervical dystonia and preclinical studies in PTSD at TOXINS 2024, a four-day neurotoxin conference held in Berlin, Germany, from Jan 17 to 20.

Cervical dystonia is a rare neurological disorder characterized by painful involuntary muscle contractions in the neck.

The open-label extension study confirmed the long-term safety and efficacy through repeated doses of ABP-450 in adult patients with moderate to severe cervical dystonia for 52 weeks.

Persistence of effect was confirmed at 12 to 16 weeks post-treatment, and safety was demonstrated by no increase in adverse events, Daewoong said.

Based on the phase 2 results, AEON Biopharma plans to discuss phase 3 studies with the FDA.

AEON Biopharma also presented results from a preclinical study of ABP-450 in PTSD.

The preclinical results showed that ABP-450 was safe for left and right stellate ganglion block (SGB) procedures, with no signs of toxicity observed, and that the combination of ABP-450 and lidocaine provided accurate dose delivery.

"We are pleased with the successful completion of ABP-450 phase 2 clinical trial for cervical dystonia and look forward to the commencement of the phase 3 study as soon as possible so that we can enter developed countries," said Park Seong-soo, Executive Vice President and Head of Global Business Division at Daewoong Pharmaceutical.