Medytox Korea, a subsidiary of Medytox, said on Tuesday that it has completed recruiting patients for a local phase 3 trial of a next-generation botulinum toxin (BTX) MBA-P01.
Medytox Korea started developing MBA-P01 as a new type of BTX in 2016.
Unlike existing BTX products that come in freeze-dried formulations, the new product is known to have used solutions manufactured with advanced technology to improve production yield and quality.
The company used a non-animal raw material medium instead of animal-derived protein during the botulinum strain culturing process.
In June, Medytox Korea obtained the regulatory nod for the phase 3 study of MBA-P01. The company started to enroll patients in August. In three months, the company recruited 318 patients.
The trial will take place at Chung-Ang University Hospital, Kangbuk Samsung Hospital, Konkuk University Medical Center, and Asan Medical Center.
The study will investigate BMA-P01’s efficacy and safety in adult patients with moderate to severe glabella lines compared to Allergan’s Botox for 16 weeks.
If the trial progresses as scheduled, Medytox Korea may release the product in the second half of 2022 at the earliest, the company said.
Medytox Korea is also conducting a local phase 2 trial of MBA-P01 separately.
Although the company has completed a phase 2 study in Australia, it will test the BTX in a phase 2 study in Korea to secure additional data to sell it in the U.S. and Europe.
Medytox Korea’s phase 3 trial of the new BTX product will help resolve uncertainties over Medytox’s sales of BTX products, which were temporarily suspended due to the regulator’s license revocation but resumed after a court recognized the company’s request for stopping the government’s administrative punishment.
Also, Medytox Korea secured an extra BTX portfolio, in addition to Meditoxin, Innotox, and Coretox.
“It is difficult to predict a court’s ruling on the revocation of the permit. But even in the worst-case scenario, we can make up for BTX sales with BMA-P01,” a Medytox official said.