Daewoong Pharmaceutical Accelerates 'Therapeutic Toxin'... Completes Patient Recruitment for Phase 2 Chronic Migraine Trial in the US

Announcement of Phase 2 Chronic Migraine Results Scheduled for Q3 Next Year

Daewoong Pharmaceutical announced on the 15th that its U.S. partner, Aeon Biopharma, has completed patient enrollment for the Phase 2 clinical trial of the botulinum toxin (BTX) 'ABP-450' for chronic migraine in the United States.

Daewoong Pharmaceutical's botulinum toxin product Nabota.
[Photo by Daewoong Pharmaceutical]

Aeon Biopharma is a partner company that Daewoong Pharmaceutical signed a contract with in 2019 for the global therapeutic business of BTX and is currently conducting clinical trials for the therapeutic indications of Nabota in the U.S.

The company stated that with the completion of patient enrollment for the Phase 2 chronic migraine trial, the planned clinical data announcement originally scheduled for the second half of 2024 will be moved up to the third quarter of the same year. Compared to the episodic migraine trial, where over 70% of patients had no prior treatment history, the chronic migraine clinical trial has a higher proportion of patients with treatment history, which is expected to reduce the placebo effect.

Aeon Biopharma is evaluating the efficacy and safety of the treatment for adult chronic migraine in this Phase 2 trial. The trial is being conducted at over 50 sites across the U.S., Canada, and Australia, involving a total of 492 patients. Eligible patients are adults experiencing headaches on 15 or more days per month and migraines on at least 8 days per month, selected through a randomized, double-blind, placebo-controlled design.

The patient groups are divided into three cohorts: low-dose (150 units), high-dose (195 units), and placebo groups. This Phase 2 trial uses a new injection method developed by Aeon Biopharma itself, allowing fewer injections compared to competing products.

Seongsu Park, Vice President of Daewoong Pharmaceutical, said, "The Phase 2 chronic migraine trial is progressing rapidly, and the entry of Daewoong Pharmaceutical's botulinum toxin into the therapeutic market is imminent," adding, "We will secure the botulinum toxin migraine treatment indication through close cooperation with Aeon Biopharma."

Meanwhile, Daewoong Pharmaceutical is targeting the global market focusing on therapeutic indications with high market potential. According to market research firm Fortune Business Insights, the global BTX market was valued at $6.5 billion (approximately 8.3 trillion KRW) last year, with the therapeutic market accounting for 53% of this. Daewoong Pharmaceutical plans to expand the range of therapeutic indications to include episodic and chronic migraine, cervical dystonia, gastroparesis, and post-traumatic stress disorder (PTSD).

This content was produced with the assistance of AI translation services.