ABVC BioPharma Provides Updates on ADHD Phase IIb Clinical Study
23 Août 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 that 60 subjects had been enrolled
and 53 had completed the eight-week study for the Company's ADHD
Phase IIb clinical study. These subjects were enrolled at the
University of California San Francisco (UCSF) Medical Center and
five Taiwanese medical centers.
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.
"At all of our sites, the enrollment of subjects participating
in our ADHD Phase IIb study is going as planned," said ABVC
BioPharma Chief Executive Officer Uttam Patil, Ph. D. "To
reach an interim analysis, the study requires 69 patients' data.
The remaining nine subjects are scheduled for screening in
September. Our clinical trials continue to demonstrate that
medicine derived from plants can have significant therapeutic
benefits, often with few - if any - side effects when treating
serious medical conditions."
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 BioPharmaABVC 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 StatementsThis 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 MastersonEmail: tmasterson@allelecomms.com
[1] https://www.prnewswire.com/news-releases/global-attention-deficit-hyperactivity-disorder-adhd-market-size-projected-to-reach-usd-32-14-billion-by-2032--with-cagr-of-7-1-study-by-polaris-market-research-301729196.html#:~:text=According%20to%20the%20research%20report,Deficit%20Hyperactivity%20Disorder%20(ADHD)%3F
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