ABVC BioPharma Announces Completion of Subject Treatment for Interim Analysis on ADHD Phase IIb Clinical Study
07 Dicembre 2023 - 2:30PM
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,"
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certain assumptions, and are subject to various known and unknown
risks and uncertainties, many of which are beyond the Company's
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actual results may differ materially from those expressed or
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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
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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
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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
Grafico Azioni ABVC BioPharma (NASDAQ:ABVC)
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Grafico Azioni ABVC BioPharma (NASDAQ:ABVC)
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Da Gen 2024 a Gen 2025