ABVC BioPharma Announces Completion of Phase II Part 2 Clinical Study Site Initiation Visit at UCSF
ABVC BioPharma announced the initiation of site visits for its Phase II Part 2 clinical study targeting ADHD at UCSF Medical Center on March 29, 2023. This study, led by Professor Keith McBurnett, involves approximately 100 patients across the U.S. and Taiwan, with 45 participants enrolled and 37 completing the eight-week study. The study follows the successful Phase II Part 1 trial, previously accepted by the FDA in October 2020. Dr. Howard Doong emphasized the fast enrollment pace and the potential therapeutic benefits of plant-derived medicines. The ADHD market is projected to grow from $13 billion in 2022 to $15 billion by 2025.
- Successful initiation of site visits for Phase II Part 2 ADHD study at UCSF.
- 45 participants currently enrolled with 37 completing the eight-week study.
- Continuation of Phase II Part 1 study, achieving primary endpoints accepted by FDA.
- Market potential for ADHD drugs with projected growth from $13 billion to $15 billion by 2025.
- None.
Fremont, CA, April 26, 2023 (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 that the site initiation visits (SIV) at the University of California San Francisco (UCSF) Medical Center was conducted on March 29, 2023. The UCSF site, led by Professor Keith McBurnett, PhD, at the UCSF Weill Institute for Neurosciences, will join five other Taiwan sites for ABVC BioPharma’s Phase II Part 2 clinical study in patients with ADHD.
The study entitled “A Phase II Tolerability and Efficacy Study of PDC-1421 Treatment in Adult Patients with Attention-Deficit Hyperactivity Disorder (ADHD), Part II” is a randomized, double-blind, placebo-controlled study involving a total of approximately 100 patients in the United States and Taiwan. Currently forty-five (45) participants are enrolled and thirty-seven (37) have completed the eight-week study. The Phase II Part 2 clinical study is a continuation of the Phase II Part 1 clinical study of ABV-1505, which was completed successfully by achieving the specified primary endpoints at UCSF and accepted by the US Food & Drug Administration in October of 2020.
“We are pleased to have Professor Keith McBurnett leading the UCSF team to perform ADHD Phase II Part 2 study,” said Dr. Howard Doong, ABVC BioPharma’s Chief Executive Officer. “The quality and fast-moving enrollment at the UCSF site will help complete the study in a timely manner.” Further, Dr. Doong emphasized the importance of ABVC BioPharma’s focus on botanical sourcing in drug development. “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 report, the ADHD drug market is valued at ~
About ABVC BioPharma
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 II of clinical development. ABVC BioPharma’s network of research institutions include 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 III.
Forward-Looking Statements
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Contact:
Tom Masterson
Email: tmasterson@allelecomms.com
FAQ
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