Daewoong’s migraine treatment to enter phase two trial in US

Daewoong Pharmaceutical’s partner company in the US is to begin a phase two study of using botulinum toxin complex injections as a preventive treatment for migraines, according to the South Korean firm Tuesday.

AEON Biopharma, a California-based private clinical-stage biopharmaceutical company, has licensed the ABP-450 injection from Daewoong Pharmaceutical and has exclusive development and distribution rights for ABP-450 in the US, Canada and the European countries.

Last year, the US biopharma’s investigational new drug application for ABP-450 was accepted by the US Food and Drug Administration.

The phase two trial will evaluate the efficacy and safety of ABP-450 for migraine prevention in adults who suffer from six or more migraine days per month.

The company plans to test the injection’s efficacy on 690 patients across the US, Canada and Australia, with both chronic and episodic migraine.

AEON Biopharma aims to be able to announce topline data in mid-2022, according to the company.

“The medical application segment in the botulinum toxin market is twice bigger than the aesthetic application segment. The medical application segment has more potential to grow,” said Park Sung-soo, head of Nabota’s business division at Daewoong Pharmaceutical.

Park added that ABP-450 could become an affordable and effective tool in the prevention of migraines.

Botulinum toxin injection is often used in wrinkle-reducing treatments. The treatments known as neuromodulators -- such as Botox, Xeomin and Dysport -- were approved by the FDA for treating migraines in 2010.

By Shim Woo-hyun (ws@heraldcorp.com)