ABVC BioPharma ADHD Phase 2 Part 2 Clinical Study First Subject Enrolled at UCSF
ABVC BioPharma, Inc. recently announced the first subject was enrolled at University of California San Francisco (UCSF) Medical Center on June 9, 2023. The UCSF site, led by Professor Keith McBurnett, PhD, Psychiatry UCSF Weill Institute for Neurosciences, joins the five (5) Taiwan sites that have begun patient enrollment for the Company’s ADHD Phase 2 Part 2 clinical study.
The study, titled A Phase 2 Tolerability and Efficacy Study of PDC-1421 Treatment in Adult Patients with Attention-Deficit Hyperactivity Disorder (ADHD), Part 2, is a randomized, double-blind, placebo-controlled study involving a total of approximately one hundred (100) patients in the US and Taiwan. A total of 53 participants have been enrolled and 43 have completed the 8-week study thus far. The Phase 2 Part 2 study is a continuation of the Phase 2 Part 1 study of ABV-1505 which was completed successfully by achieving the protocol specified primary end points at UCSF and accepted by the US FDA in October of 2020.
“We are pleased to see the first subject enrolled and a few more subjects currently being screened for the ADHD Phase 2 Part 2 study at UCSF,” said Dr. Howard Doong, ABVC BioPharma’s Chief Executive Officer. Further, Dr. Doong emphasized the importance of ABVC BioPharma’s drug development focus on botanical-based pharmaceuticals. “Our clinical trials continue to demonstrate that medicines derived from plants have significant therapeutic benefits with few – if any – side effects in treating serious medical conditions.”
According to Grand View Research’s market research report, the ADHD drug market is valued at $16.4 billion in 2018 and expected to reach $24.9 billion by 2025 with the CAGR of 6.4% over the forecast period. (Grand View Research).
ABVC BioPharma is a clinical-stage biopharmaceutical company with an active pipeline of six drugs and one medical device (ABV-1701/Vitargus) under development. For its drug products, the company utilizes in-licensed technology from its network of world-renowned research institutions to conduct proof-of-concept trials through Phase 2 of clinical development. The company’s network of research institutions includes Stanford University, University of California at San Francisco, and Cedars-Sinai Medical Center. For Vitargus, the company intends to conduct global clinical trials through Phase 3.
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