ABVC BioPharma Provides ADHD Phase II Part 2 Clinical Update
ABVC Biopharma (NASDAQ: ABVC) announced the progress of its Phase II Part II clinical study for its ADHD treatment, ABV-1505. As of now, 22 out of 32 screened subjects have been enrolled, with one completing the 8-week treatment. The study, which is double-blind and placebo-controlled, aims to enroll around 100 patients and is conducted at five hospitals in Taiwan and the University of California, San Francisco. The ADHD drug market is projected to grow from USD 16.4 billion in 2018 to USD 24.9 billion by 2025. Dr. Howard Doong expressed optimism about ongoing recruitment rates.
- 22 subjects enrolled out of a targeted 100 in Phase II Part II study.
- Successful completion of Phase II Part I study accepted by FDA in October 2020.
- Market for ADHD drugs projected to grow significantly by 2025.
- None.
FREMONT, CA, July 13, 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 the enrollment progress in the Phase II Part II clinical study of the Company’s ADHD medicine (ABV-1505). Since results on the first subject treated were reported on May 10, 2022, a total of 22 subjects have been enrolled in the study from a total of 32 subjects screened. One of the enrolled participants from the three arms completed the 8-week treatment per the study design.
The study, 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 II,” is expected to eventually enroll approximately 100 patients.
Five prestigious research hospitals in Taiwan and the research hospital at the University of California, San Francisco are participating in the study, which is a continuation of the Phase II Part I study of ABV-1505, completed successfully at UC, San Francisco and accepted by the U.S. Food & Drug Administration in October 2020.
“We are pleased to see 22 subjects have been enrolled in the Phase II Part II ADHD clinical trial, and one participant has completed the 8-week treatment,” said Dr. Howard Doong, Chief Executive Officer of ABVC BioPharma. “We expect to maintain the strong recruiting rates and look forward to announcing more study progress.”
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 the CAGR of
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.
Forward-Looking Statements
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.
Contact:
ICR, LLC
Lucy Peng
Phone: +1 646-677-1872
Email: Lucy.Peng@icrinc.com
FAQ
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