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

Rhea-AI Summary

ABVC BioPharma, Inc. (NASDAQ: ABVC) provided an update on the eight-week long ADHD Phase II part II clinical study at the University of California San Francisco Medical Center and five Taiwanese medical centers. Out of 94 screened subjects, 69 enrolled, and 60 completed the study. The Phase II part I clinical study successfully achieved primary endpoints and was accepted by the FDA. The CEO expects positive results in the interim analysis report and plans to continue the study by enrolling another thirty patients. The global ADHD treatment market is projected to reach $32.14 billion by 2030.

FREMONT, CA, Dec. 07, 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 II part II clinical study taking place at the University of California San Francisco (UCSF) Medical Center and five Taiwanese medical centers. A total of 94 subjects were screened, out of which 69 enrolled in the study; 60 subjects completed the eight-week 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 100 patients in the United States and Taiwan. The Phase II part II clinical study continues the Phase II part I clinical study of ABV-1505. Phase II part I of the study successfully achieved the specified primary endpoints at UCSF and was accepted by the U.S. Food & Drug Administration in October 2020. 

"All of the subjects who completed the study showed a positive approach to the study during their participation," said ABVC BioPharma Chief Executive Officer Uttam Patil, Ph. D. "Following the successful completion of the eight-week long treatment, we expect to hear a positive result in the interim analysis report and hope to continue the study in the next part by enrolling another thirty patients to complete the Phase II study. We expect our clinical trials will continue to demonstrate that plant medicine can have significant therapeutic benefits, often with few - if any - side effects."  

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 pivotal clinical trials for PMA (pre-Market Approval).

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.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy any of the Company's securities, nor shall such securities be offered or sold in the United States absent registration or an applicable exemption from registration, nor shall there be any offer, solicitation or sale of any of the Company's 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 such state or jurisdiction.

Contact:
Leeds Chow
Email: leedschow@ambrivis.com

What is the update provided by ABVC BioPharma, Inc. (NASDAQ: ABVC)?

ABVC BioPharma, Inc. (NASDAQ: ABVC) provided an update on the eight-week long ADHD Phase II part II clinical study at the University of California San Francisco Medical Center and five Taiwanese medical centers.

How many subjects were screened for the study?

A total of 94 subjects were screened for the study.

How many subjects completed the eight-week study?

60 subjects completed the eight-week study.

What was the outcome of the Phase II part I clinical study?

The Phase II part I clinical study successfully achieved the specified primary endpoints at UCSF and was accepted by the U.S. Food & Drug Administration in October 2020.

What is the CEO's expectation for the study?

The CEO expects to hear positive results in the interim analysis report and plans to continue the study by enrolling another thirty patients.

What is the projected value of the global ADHD treatment market by 2030?

The global ADHD treatment market is expected to reach $32.14 billion by 2030.