(Health Korea News / Lee Chang-yong) Yungjin Pharmaceutical announced on the 19th that it had confirmed the possibility of success through the interim analysis of the phase 2 clinical trial of ‘KL1333’, a mitochondrial disorder treatment candidate that was transferred to Swedish bio company Abliva in 2017 and is currently undergoing global clinical trials. (See related article below)
The company cited Abliva and explained that the interim analysis results of the phase 2 clinical trial of KL1333 confirmed that KL1333 passed the safety and futility assessment in adult patients with mitochondrial diseases, and the DMC (Data Monitoring Committee) recommended that the clinical trial be continued with 180 patients without any changes to the clinical design.
Based on the results of this interim analysis, Abliva plans to continue the clinical trial of KL1333, with final patient recruitment expected to begin in the second half of 2024.
Yungjin Pharmaceutical said, “If the clinical and commercialization of KL1333 is successful, Yungjin Pharmaceutical will receive milestones worth hundreds of billions of won,” and predicted, “Yungjin Pharmaceutical’s profits will be maximized even more, as royalties from sales will be separate.” They continued, “Yungjin Pharmaceutical still holds the rights to Korea and Japan, so additional profits can be expected.”
Ellen Donnelly, CEO of Abliva, said, “There are approximately 85,000 patients with rare mitochondrial disorders in the U.S. and Europe, and we expect KL1333 to address this unmet medical need,” Yungjin Pharmaceutical reported on the same day.
“We are delighted with the positive results of the interim analysis of the KL1333 Phase 2 clinical trial,” said Lee Ki-soo, CEO of Yungjin Pharmaceutical. “We will continue to maintain a close partnership with Abliva to ensure the successful completion of the global clinical trial of KL1333.”
Meanwhile, KL1333 was designated as an orphan drug by the European Medicines Agency (EMA) and the U.S. FDA in 2017 and 2018, respectively. In September of last year, it was designated as a fast track by the U.S. FDA. In June of this year, the 24-week administration of KL1333 to the 40th patient in the first round of recruitment was completed.
Copyright © Health Korea News. Unauthorized reproduction and redistribution prohibited.
Source: www.hkn24.com
