|ABVC BioPharma Provides ADHD Phase II Part 2 Clinical Study Update and Announces UCSF Institutional Review Board Approval|
|By: GlobenewsWire - 23 Sep 2022||Back to overview list
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.
The Part 1 study found that the active ingredient of ABV-1505, PDC-1421, was safe, well-tolerated and efficacious during the treatment and follow-up period with six adult patients. For the primary endpoints, the percentages of improvement in Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Investigator Rated-IV (ADHD-RS-IV) score from baseline through eight weeks of treatment were 83.3% (N=5) in the Intention-To-Treat (ITT) population and 80.0% (N=4) in the Per-Protocol (PP) population. Both low and high doses of PDC-1421 met the primary end points by passing the required 40% population in ADHD-RS-IV test scores. Overall, the results from the Part 1 study demonstrated the therapeutic value of PDC-1421 and support further clinical development of ABV-1505 for the treatment of ADHD.
“We are pleased to see 30 subjects have been enrolled in the Phase II Part 2 ADHD clinical trial, and 18 participants have completed the 8-week treatment,” said Dr. Howard Doong, Chief Executive Officer of ABVC BioPharma. “We are also delighted that the University of California, San Francisco is involved in the Phase II Part 2 study. With UCSF participation, in addition to the five Taiwan sites, we anticipate that enrollment for the study will accelerate substantially, and worldwide we are expecting to complete the Part 2 study in the third quarter of 2023.”
According to Grand View Research’s market research report, the ADHD drug market is valued at USD 16.4 billion in 2018 and expected to reach USD 24.9 billion by 2025 with a CAGR of 6.4% over the forecast period.
Grand View Research. Attention Deficit Hyperactivity Disorder Market Size, Share & Trends Analysis Report By Drug Type (Stimulant, Non-stimulant), By Demographic, By Distribution Channel (Hospital & Retail Pharmacy), And Segment Forecasts, 2019 – 2025.https://www.grandviewresearch.com/industry-analysis/attention-deficit-hyperactivity-disorder-adhd-market
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