ABVC BioPharma Provides ADHD Phase II Part 2 Clinical Study Update and Announces UCSF Institutional Review Board Approval
Fremont, CA - (NewMediaWire) - September 22, 2022 - 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
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.
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential,” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified, and, consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) our inability to manufacture our product candidates on a commercial scale on our own, or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; and (v) difficulties in securing regulatory approval to proceed to the next level of the clinical trials or to market our product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.
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