ABVC BioPharma Announces Completion of Phase II Part 2 Clinical Study Site Initiation Visit at UCSF

Fremont, CA - (NewMediaWire) - April 26, 2023 - ABVC BioPharma, Inc. (NASDAQ: ABVC), a clinical stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, today announced that the site initiation visits (SIV) at the University of California San Francisco (UCSF) Medical Center was conducted on March 29, 2023. The UCSF site, led by Professor Keith McBurnett, PhD, at the UCSF Weill Institute for Neurosciences, will join five other Taiwan sites for ABVC BioPharma’s Phase II Part 2 clinical study in patients with ADHD.

The study entitled “A Phase II Tolerability and Efficacy Study of PDC-1421 Treatment in Adult Patients with Attention-Deficit Hyperactivity Disorder (ADHD), Part II” is a randomized, double-blind, placebo-controlled study involving a total of approximately 100 patients in the United States and Taiwan. Currently forty-five (45) participants are enrolled and thirty-seven (37) have completed the eight-week study. The Phase II Part 2 clinical study is a continuation of the Phase II Part 1 clinical study of ABV-1505, which was completed successfully by achieving the specified primary endpoints at UCSF and accepted by the US Food & Drug Administration in October of 2020. 

“We are pleased to have Professor Keith McBurnett leading the UCSF team to perform ADHD Phase II Part 2 study,” said Dr. Howard Doong, ABVC BioPharma’s Chief Executive Officer.  “The quality and fast-moving enrollment at the UCSF site will help complete the study in a timely manner.” 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 - if any - side effects in treating serious medical conditions.”  

According to Grand View Research’s market report, the ADHD drug market is valued at ~$13 billion in 2022 and expected to reach ~$15 billion by 2025 with a CAGR of 4.2% over the forecast period. (Grand View Research)

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, the company utilizes in-licensed technology from its network of world-renowned research institutions to conduct proof-of-concept trials through Phase II of clinical development. ABVC BioPharma’s network of research institutions include Stanford University, University of California at San Francisco, and Cedars-Sinai Medical Center. For Vitargus®, the company intends to conduct global clinical trials through Phase III.

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. None of the outcomes expressed herein are guaranteed. 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:

Tom Masterson

Email: tmasterson@allelecomms.com