ABVC BioPharma Provides ADHD Phase II Part 2 Clinical Study Update and Announces UCSF Institutional Review Board Approval
Excerpt from the Press Release:
FREEMONT, CA, Sept. 23, 2022 (GLOBE NEWSWIRE) — via NewMediaWire — ABVC Biopharma, Inc. (NASDAQ: ABVC), a clinical-stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, today announced enrollment progress in the Phase II Part 2 clinical study of the Company’s ADHD medicine, ABV-1505, currently being conducted at five prestigious medical centers in Taiwan. The Part 2 study is a randomized, double-blind, placebo-controlled study, titled “A Phase II Tolerability and Efficacy Study of PDC-1421 Treatment in Adult Patients with Attention-Deficit Hyperactivity Disorder (ADHD), Part 2” and is expected to eventually enroll approximately 100 patients in Taiwan and the United States.
Since results of the first subject treated in Taiwan were reported on May 10, 2022, 30 subjects have now been enrolled in the study from a total of 43 subjects screened. Eighteen of the enrolled participants have already completed the 8-week treatment in accordance with the study design.
In addition, the company has been notified that the University of California, San Francisco (UCSF) Medical Center Institutional Review Board has approved participation in the Part 2 study, set to begin in the fourth quarter of this year. Part 1 of the Phase II study of ABV-1505 was conducted at UCSF from January 2020 through July 2020 and was accepted by the US Food & Drug Administration in October of 2020.
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