Securing Statistical Significance Compared to Placebo Group in All Treatment Groups for Primary Evaluation Variables
[Asia Economy Reporter Lee Gwan-joo] Daewoong Pharmaceutical disclosed the topline results of the Phase 2 clinical trial in the United States for its botulinum toxin 'Nabota (ABP-450)' targeting cervical dystonia on the 27th.
Daewoong Pharmaceutical's partner, Eon BioPharma, conducted a multicenter, randomized, double-blind, Phase 2, placebo-controlled clinical trial involving patients with cervical dystonia at 20 institutions across the United States.
Patients were evenly divided into four dosing groups: low dose (150U), medium dose (250U), high dose (350U), and placebo. After a 20-week follow-up, the primary endpoint, the TWSTRS (Toronto Western Spasmodic Torticollis Rating Scale) score at 4 weeks post-administration, showed a score of 3.57 for the placebo group, while the 150U, 250U, and 350U groups scored 14.01, 11.28, and 9.92 respectively, demonstrating significant efficacy in all three dosing groups compared to placebo.
Furthermore, despite administering up to the maximum dose of 350U used for botulinum toxin treatment, no serious adverse reactions were observed, and only adverse reactions similar to or lower than those of other botulinum toxin products were noted, confirming its safety.
Nabota has already received approval from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the cosmetic indication of glabellar lines, so if the therapeutic indication clinical trial is successful, approval is expected to proceed smoothly.
Park Sung-soo, Vice President of Daewoong Pharmaceutical, said, “Entering the advanced botulinum toxin treatment market led by the United States is a representative future growth engine that Daewoong Pharmaceutical has long prepared with its partner. We are pleased to announce positive Phase 2 topline results,” adding, “We expect to contribute to the public good in the U.S. by supplying Nabota to American patients at a reasonable price.”
Meanwhile, Eon BioPharma, Daewoong Pharmaceutical’s exclusive partner for the botulinum toxin treatment business, is conducting Phase 2 clinical trials for indications including cervical dystonia and chronic and episodic migraine. Topline results for migraine are expected in the second half of next year.
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