Samjin Pharmaceutical-Aribio Hold Expert Meeting on Phase 3 Oral Dementia Drug
Oral Multi-Target Dementia Treatment 'AR1001'
Samjin Pharmaceutical and Aribio announced on the 11th that they held a meeting with key clinicians and experts ahead of the commencement of the domestic Phase 3 clinical trial of the multi-mechanism oral dementia treatment 'AR1001.'
Samjin Pharmaceutical and Aribio announced on the 11th that they held a meeting with key clinicians and experts ahead of the domestic Phase 3 clinical trial initiation of the multi-mechanism oral dementia treatment 'AR1001'. Photo from the expert meeting site.
[Photo by Samjin Pharmaceutical]
During the meeting, the two companies reported that they discussed practical collaboration on the joint clinical trial of AR1001 with domestic experts, gathered opinions on patient selection and exclusion criteria, and addressed other current issues. Aribio is currently conducting the global final clinical trial of AR1001 with 1,250 participants, and in Korea, the Phase 3 clinical trial was approved by the Ministry of Food and Drug Safety last August.
The meeting was attended by over 40 participants, including leading neurology professors and clinicians specializing in Alzheimer's disease from domestic university hospitals and general hospitals, clinical experts from both companies conducting the global Phase 3 trial of AR1001, Aribio advisor Ryu Geun-hyuk, and Daewon Medax CEO Yoo Mu-young. Additionally, key industry-academia-government stakeholders such as Noh Yeon-hong, Chairman of the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, Park In-seok, Chairman of the Korea National Clinical Trial Support Foundation, and Yang Dong-won, Chairman of the Korean Dementia Association (Professor of Neurology at Seoul St. Mary’s Hospital) also participated.
The expert meeting proceeded with a report on the 'AR1001 Global Phase 3 Clinical Trial Update' by Aribio CEO Jeong Jae-joon, followed by introductions of the Korean Phase 3 clinical trial plans and protocols by field, and discussions with clinicians regarding patient recruitment criteria.
In particular, the company emphasized that a briefing on the Phase 3 clinical trial support by the Korea National Clinical Trial Support Foundation was conducted for AR1001, which has been designated as the first public interest clinical trial product. The foundation agreed to support by providing patient numbers and recommended researcher information per participating hospital, linking researchers, offering clinical trial information to the general public, and facilitating participant recruitment and connection with conducting institutions through a dedicated support counseling center.
Ha Jung-eun, Secretary General of the Korea National Clinical Trial Support Foundation, stated, "We expect Korean patient enrollment to begin within this year and plan to actively utilize the Korean Clinical Trial Participation Portal to support patient recruitment and clinical trials." She added, "Since Aribio’s dementia treatment addresses a significant unmet medical need and is a nationally managed disease with high public interest, we are preparing to create a dedicated homepage for dementia clinical trial patient support on the portal and to operate a dedicated counseling center."
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Choi Yong-joo, CEO of Samjin Pharmaceutical, said, "Samjin Pharmaceutical and Aribio are closely cooperating to develop and successfully bring to market a patient-centered, safe, and effective dementia treatment." He added, "In particular, Samjin Pharmaceutical is making thorough preparations to serve not only as a domestic supplier but also as the global production and supply source for AR1001 in the future."
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