Fremont, CA - (NewMediaWire) - February 02, 2022 - ABVC Biopharma, Inc. (NASDAQ: ABVC), a clinical stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, today announced that the Principal Investigator Meeting for the ABV-1505 Phase II Part 2 ADHD clinical study will be held on February 14, 2022. Principal investigators from the University of California San Francisco (“UCSF”) Medical Center and five prestigious Taiwan medical centers, including National Taiwan University Hospital, Taipei Veterans General Hospital, Linkou Chang Gung Memorial Hospital, Kaohsiung Chang Gung Memorial Hospital and Cheng Hsin General Hospital, will virtually participate in the meeting to discuss potential further improvement to the study protocol prior to initiation.
This randomized, double-blind, placebo-controlled Part 2 study involves a total of approximately 100 patients from the United States and Taiwan. Part 1 of the Phase II study on ABV-1505 was conducted at UCSF from January to July of 2020 and received by the U.S. Food & Drug Administration in October of 2020, without comment. The Part 2 study is targeted to begin in the first quarter of 2022 and expected to be completed at the end of 2022.
The Part 1 study with six adult patients found that the active ingredient of ABV-1505, PDC-1421, was safe, well-tolerated and effective during the treatment and follow-up period. For the primary endpoints, the percentage of improvement in Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Investigator Rated-IV (ADHD-RS-IV) score from baseline through eight weeks of treatment was 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 endpoints, passing the required 40% population in ADHD-RS-IV test scores. 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 expect to have a productive discussion finalizing the Part 2 study protocol on February 14th,” said Dr. Howard Doong, Chief Executive Officer of ABVC BioPharma. “Site initiation visits will quickly follow the meeting to initiate the study at all participating sites.” Further, Dr. Doong emphasized the importance of ABVC BioPharma’s focus on botanical sourcing in drug development. “Our clinical trials continue to demonstrate the significant therapeutic benefits of our plant-based medicines with few - if any - side effects in treating certain serious medical conditions.”
According to Grand View Research’s market research report, the ADHD drug market was valued at US$16.4 billion in 2018 and expected to reach US$24.9 billion by 2025 with a CAGR of 6.4% over the forecast period.1
1 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. Retrieved from https://www.grandviewresearch.com/industry-analysis/attention-deficit-hyperactivity-disorder-adhd-market.
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, it is focused on utilizing its licensed technology to conduct proof-of-concept trials through Phase II of the clinical development process at world-famous research institutions (such as Stanford University, University of California at San Francisco, and Cedars-Sinai Medical Center). For Vitargus, the company intends to conduct the clinical trials through Phase III at various locations throughout the globe.
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