ABVC BioPharma ADHD Phase II Part 2 Clinical Study First Subject Enrolled at UCSF
Fremont, C, June 12, 2023 (GLOBE NEWSWIRE) — via NewMediaWire — ABVC BioPharma, Inc. (NASDAQ: ABVC) (“Company”), a clinical-stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, neuropsychiatric conditions, and ophthalmology, today announced that the first subject was enrolled at University of California San Francisco (UCSF) Medical Center on June 9, 2023. The UCSF site, led by Professor Keith McBurnett, PhD, Psychiatry UCSF Weill Institute for Neurosciences, joins the five (5) Taiwan sites that have begun patient enrollment for the Company’s ADHD Phase II Part 2 clinical study.
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 one hundred (100) patients in the United States and Taiwan. A total of fifty-three (53) participants have been enrolled and forty-three (43) have completed the eight-week study thus far. The Phase II Part 2 study is a continuation of the Phase II Part 1 study of ABV-1505 which was completed successfully by achieving the protocol specified primary end points at UCSF and accepted by the US Food & Drug Administration in October of 2020.
“We are pleased to see the first subject enrolled and a few more subjects currently being screened for the ADHD Phase II Part 2 study at UCSF,” said Dr. Howard Doong, ABVC BioPharma’s Chief Executive Officer. Further, Dr. Doong emphasized the importance of ABVC BioPharma’s drug development focus on botanical-based pharmaceuticals. “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 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 6.4% over the forecast period. (Grand View Research)
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, 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. The company’s network of research institutions includes 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.
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. 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
