ABVC BioPharma Announces Enrollment Progress for ADHD Phase II Part 2 Clinical Study
ABVC Biopharma, Inc. (NASDAQ: ABVC) reported significant progress in the Phase II part 2 clinical trial of its ADHD medication, ABV-1505. As of June 1, 2022, a total of 14 subjects have begun treatment out of 100 expected participants. This randomized, double-blind, placebo-controlled study is conducted at five major hospitals in Taiwan and UCSF. The Phase I part of this study was successful and approved by the FDA in October 2020. The ADHD drug market is projected to grow from $16.4 billion in 2018 to $24.9 billion by 2025, indicating promising market potential for ABVC's product.
- Strong enrollment progress in Phase II part 2 ADHD clinical trial with 14 out of 100 subjects enrolled.
- Successful completion of Phase I study at UCSF, previously accepted by the FDA.
- Participation of prestigious research hospitals in the trial supports credibility.
- None.
FREMONT, CA, June 01, 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 the enrollment progress for the Phase II part 2 clinical study of the Company’s ADHD medicine (ABV-1505). Since the first subject began treatment on May 10, 2022, 13 additional subjects have been enrolled in the study from a total of 23 subjects screened.
The randomized, double-blind, placebo-controlled study, titled “A Phase II Tolerability and Efficacy Study of PDC-1421 Treatment in Adult Patients with Attention-Deficit Hyperactivity Disorder (ADHD), Part II,” is expected to eventually involve approximately 100 patients.
Five prestigious research hospitals in Taiwan and the research hospital at the University of California, San Francisco, will participate in the study, which is a continuation of the Phase II part 1 study of ABV-1505 completed successfully at UC, San Francisco, and accepted by the U.S. Food & Drug Administration in October 2020.
“We are extremely pleased to see the strong enrollment progress in the Phase II part 2 ADHD clinical trial,” said Dr. Howard Doong, Chief Executive Officer of ABVC BioPharma. “We expect to maintain these outstanding recruiting rates and look forward to announcing more on our study progress.”
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
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
FAQ
What is the purpose of ABVC's Phase II clinical study for ABV-1505?
How many subjects are involved in the Phase II part 2 study for ABV-1505?
What are the previous results from the Phase I study of ABV-1505?
What is the market potential for ADHD medications?
Which institutions are conducting the clinical trials for ABV-1505?
