ABVC BioPharma ADHD Phase II Part 2 Clinical Study First Subject Treated
FREMONT, CA, May 10, 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 the first subject began treatment at the Cheng Hsin General Hospital in the Phase II part 2 clinical study of the Company’s ADHD medicine (ABV-1505). 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. This is a continuation of the Phase II part 1 study of ABV-1505, which was completed successfully at the University of California, San Francisco and accepted by the U.S. Food & Drug Administration in October 2020.
Cheng Hsin General Hospital is one of five sites in Taiwan that will participate in part 2 of the clinical trial, along with the UC, San Francisco site in the United States. At Cheng Hsin, five subjects were enrolled and randomized into the study from a total of twelve subjects screened from the participating sites, as prescribed by the study protocol inclusion and exclusion criteria.
“We are extremely pleased to see the first subject treated with the first dose of an 8-week treatment period in the Phase II part 2 ADHD clinical trial,” said Dr. Howard Doong, Chief Executive Officer of ABVC BioPharma. “We expect excellent subject recruiting rates and look forward to providing updates on the trial’s enrollment status soon.”
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. (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
