Samjin Pharmaceutical and AriBio are accelerating clinical trial preparations to develop a homegrown dementia treatment.

Samjin and AriBio said Wednesday that they completed an expert meeting, "POLARIS AD AR1001 Global PⅢ Trial Meeting," last Friday and Saturday ahead of the domestic phase 3 clinical trial of their oral dementia treatment candidate, AR1001.

The expert meeting drew leading neurology professors and clinicians in Alzheimer's, who discussed major clinical issues, including clinical trial collaboration, patient selection, and exclusion criteria. During the meeting, AriBio CEO Choung Jai-jun introduced the status of the global phase 3 clinical trial of AR1001 and unveiled the Korean phase 3 trial protocol.

Also attending the event were the heads of major industry and research organizations, including Noh Yeon-hong, chairman of the Korea Pharmaceutical and Biopharma Manufacturers Association, Park In-seok chairman of the Korean National Evidence-based Clinical Trials (KoNECT), and Yang Dong-won Yang, chairman of the Korean Association for Dementia.

AriBio plans to recruit about 1,250 patients in the U.S., Europe, China, and Korea to conduct a global phase 3 trial of AR1001. Following the U.S. Food and Drug Administration (FDA), the company received approval for its domestic phase 3 IND (Investigational New Drug) application from the Ministry of Food and Drug Safety in August.

As AR1001 has been designated as a public interest clinical trial No. 1, KoNECT will provide information on the number of patients and recommended researchers for each participating hospital, connect with researchers, provide clinical trial information to the public, recruit participants through the participation support counseling center, and connect them with sites.

"In anticipation of the start of Korean clinical patient enrollment this year, we plan to support clinical trials by using the Korean clinical trial participation portal for patient recruitment," KoNECT Executive Director Ha Jeong-eun said. "Given the large unmet medical need and high public profile of this nationally managed disease, we are preparing to create a dedicated homepage for dementia clinical patient support on the portal and launch a dedicated consultation center."

Samjin Pharmaceutical CEO Choi Yong-ju said, “Samjin and AriBio are working closely to develop safe and effective dementia treatments that are patient-centered and successful. We are making full preparations to serve as a global production source for AR1001 in Korea and the world."