In Phase 2 Clinical Trial in the U.S.
Daewoong Pharmaceutical announced on Sept. 28 that its botulinum toxin ABP-450 (Korean product name: Nabota) has proved effective for treating cervical dystonia in U.S. phase 2 clinical trials.
The company unveiled the topline results of the clinical trials, which have been carried out by AEON Biopharma, Daewoong's exclusive partner for its botulinum toxin treatment business in developed countries. AEON Biopharma conducted multisystem, randomized, double-blind, Phase II, and placebo-controlled clinical trials at 20 U.S. institutions for cervical dystonia patients.
The patients were divided into four dosing groups -- a low dose (150U) group, a medium dose (250U) group, a high dose (350U) group and a placebo group with a 1:1:1:1 ratio. Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) points at the fourth week of the administration were 3.57 for the placebo group, but 14.01 for the 150U group, 11.28 for the 250U group, and 9.92 for the 350U group. All the three groups showed meaningful effects compared to the placebo group.
In addition, no serious adverse reactions appeared despite the administration of the botulinum toxin up to 350U, the maximum dose used for botulinum toxin treatment, and only adverse reactions similar to or lower than those of other botulinum toxin formulations were observed, proving the safety of Daewoong's product.
Nabota has already been approved for cosmetic use by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The drug expected to receive approval as a treatment of cervical dystonia without difficulties if the clinical trials become successful.