ABVC BioPharma Announces Completion of Subject Recruitment for Interim Analysis on ADHD Phase IIb Clinical Study

2023-10-17

临床2期临床结果

FREMONT, CA, Oct. 17, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – ABVC BioPharma, Inc. (NASDAQ: ABVC) ("Company"), a clinical-stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, today announced an update on the Company's eight-week long ADHD Phase IIb clinical study taking place at the University of California San Francisco (UCSF) Medical Center and five Taiwanese medical centers. Sixty-nine subjects enrolled in the study, 50 completed the study, and 11 are currently undergoing treatment.

The study entitled "A Phase IIb Study of PDC-1421 Capsule to Evaluate the Safety and Efficacy in Patients with Adult Attention-Deficit/Hyperactivity Disorder" is a randomized, double-blind, placebo-controlled study involving a total of approximately 100 patients in the United States and Taiwan. The Phase IIb clinical study continues the Phase IIa clinical study of ABV-1505. Phase IIa successfully achieved the specified primary endpoints at UCSF and was accepted by the U.S. Food & Drug Administration in October 2020.

"We received a favorable response from the subjects participating in our ADHD Phase IIb study at all of our sites," said ABVC BioPharma Chief Executive Officer Uttam Patil, Ph. D. "To reach an interim analysis, the study requires 69 patients' data. Our clinical trials continue to demonstrate that medicine derived from plants can have significant therapeutic benefits, often with few - if any - side effects. We expect to report similar results in our interim analysis report."

According to the Polaris market research report, the global ADHD treatment market was valued at $16.13 billion in 2022 and is expected to reach $32.14 billion by 2030 with a CAGR of 7.1% over the forecast period.[1]

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. ABVC BioPharma's network of research institutions includes Stanford University, the 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." The words may precede such statements as "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. Accordingly, none of the outcomes expressed herein are guaranteed. Such risks and uncertainties include, without limitation, risks and uncertainties associated with the following:

Our inability to manufacture our product candidates on a commercial scale on our own or in collaboration with third parties.

Difficulties in obtaining financing on commercially reasonable terms.

Changes in the size and nature of our competition.

Loss of one or more key executives or scientists.

Difficulties in securing regulatory approval to proceed to the next level of 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 outlined 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 due to new information, future events, or otherwise.

Contact:

Tom Masterson

Email: tmasterson@allelecomms.com

[1] https://www.polarismarketresearch.com/industry-analysis/attention-deficit-hyperactivity-disorder-market