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ABVC BioPharma Completes Site Initiation Visits and Begins Enrollments for ADHD Phase II Part 2 Clinical Study

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ABVC BioPharma, Inc.
ABVC BioPharma, Inc.

FREMONT, CA, April 28, 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 that all five clinical study sites in Taiwan participating in the Phase II, part 2 clinical study of the company’s ADHD medicine have completed their site initiation visits (SIV).

The study, titled “A Phase II Tolerability and Efficacy Study of PDC-1421 Treatment in Adult Patients with Attention-Deficit Hyperactivity Disorder (ADHD) Part 2,” is a randomized, double-blind, placebo-controlled study that includes a total of approximately 100 patients in the United States and Taiwan. This resumes the Phase II Part 1 study of ABV-1505, successfully completed at the University of California, San Francisco, and accepted by the U.S. Food & Drug Administration in October 2020.

“We are pleased to complete five site initiation visits (SIV) and initiate patient enrollment for the Phase II Part 2 ADHD clinical trial,” said Dr. Howard Doong, Chief Executive Officer of ABVC BioPharma. “The UCSF site will complete its IRB approval soon and quickly join study patient enrollment.” 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 side effects in treating serious medical conditions.”

According to Grand View Research’s market research report, the ADHD drug market was 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. (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.

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