ABVC BioPharma Announces Completion of Subject Treatment for Interim Analysis on ADHD Phase IIb Clinical Study
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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
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
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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
FAQ
What is the update provided by ABVC BioPharma, Inc. (NASDAQ: ABVC)?
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