ABVC BioPharma Completes Site Selection for ABV-1505 ADHD Phase II Part 2 Clinical Study
ABVC Biopharma (NASDAQ: ABVC) announced the completion of clinical site selection for its ABV-1505 ADHD Phase II Part 2 study. This multi-nation study will involve approximately 100 patients and is set to commence in Q1 2022, following the IRB submissions. The principal investigators are from prestigious institutions, including UCSF and major medical centers in Taiwan. ABVC aims to demonstrate the efficacy and safety of ABV-1505, emphasizing its focus on botanical sourcing in drug development. The study's completion is anticipated by late 2022.
- Completion of clinical site selection for ABV-1505 ADHD Phase II Part 2 study.
- Study involves approximately 100 patients across multiple esteemed medical centers.
- Study expected to provide proof of efficacy and safety for ABV-1505.
- Completion of the study is not guaranteed and is subject to various risks.
- Potential difficulties in securing regulatory approval for further clinical trials.
Completion of the Study Expected by the End of 2022
FREMONT, CA, Sept. 13, 2021 (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 it has completed clinical site selection for its ABV-1505 Attention-Deficit Hyperactivity Disorder (ADHD) Phase II Part 2 study. The Phase II, Part 1 study, completed at the University of California, San Francisco, was accepted by the US Food & Drug Administration in October 2020. The Part 2 study of ABV-1505 (ADHD) is a multi-nation multi-site randomized, double-blind, placebo-controlled study involving approximately 100 patients.
The study sites selected are the University of California, San Francisco (UCSF) in the USA and five prestigious medical centers in Taiwan, including the National Taiwan University (NTU) Hospital, Cheng Hsin General Hospital, Linkou Chang Gung Memorial Hospital, Kaohsiung Chang Gung Memorial Hospital, and Taipei Veterans General Hospital. In parallel with the Institutional Review Board (IRB) submission at UCSF, a central IRB (cIRB) submission of the protocol and study-related dossiers will be issued by ABVC in Q4, 2021 for all five Taiwan sites. The study is targeted to begin in the first quarter of 2022.
“All of the principal investigators and sites selected are highly regarded worldwide, for their work in the treatment of ADHD,” said Dr. Howard Doong, ABVC BioPharma’s chief executive officer. “We believe that the Phase II Part 2 study, which we expect to be completed in late 2022, will provide preliminary proof of the efficacy and safety of ABV-1505.” 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.”
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 world.
Forward-Looking Statements
Clinical trials are in early stages, and there is no guarantee that any specific outcome will be achieved. 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.
This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that state or jurisdiction.
Contact:
Andy An – Chief Financial Officer
765-610-8826
press@ambrivis.com
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