ABVC BioPharma Provides ADHD Phase II Part 2 Clinical Study Update and Announces UCSF Institutional Review Board Approval
23 September 2022 - 10:30PM
via NewMediaWire -- ABVC Biopharma, Inc. (NASDAQ: ABVC), a
clinical-stage biopharmaceutical company developing therapeutic
solutions in oncology/hematology, CNS, and ophthalmology, today
announced enrollment progress in the Phase II Part 2 clinical study
of the Company’s ADHD medicine, ABV-1505, currently being conducted
at five prestigious medical centers in Taiwan. The Part 2 study is
a randomized, double-blind, placebo-controlled study, titled “A
Phase II Tolerability and Efficacy Study of PDC-1421 Treatment in
Adult Patients with Attention-Deficit Hyperactivity Disorder
(ADHD), Part 2” and is expected to eventually enroll approximately
100 patients in Taiwan and the United States.
Since results of the first subject treated in Taiwan were
reported on May 10, 2022, 30 subjects have now been enrolled in the
study from a total of 43 subjects screened. Eighteen of the
enrolled participants have already completed the 8-week treatment
in accordance with the study design.
In addition, the company has been notified that
the University of California, San Francisco (UCSF) Medical Center
Institutional Review Board has approved participation in the Part 2
study, set to begin in the fourth quarter of this year. Part 1 of
the Phase II study of ABV-1505 was conducted at UCSF from January
2020 through July 2020 and was accepted by the US Food & Drug
Administration in October of 2020.
The Part 1 study found that the active ingredient
of ABV-1505, PDC-1421, was safe, well-tolerated and efficacious
during the treatment and follow-up period with six adult patients.
For the primary endpoints, the percentages of improvement in Adult
Attention-Deficit/Hyperactivity Disorder Rating Scale-Investigator
Rated-IV (ADHD-RS-IV) score from baseline through eight weeks of
treatment were 83.3% (N=5) in the Intention-To-Treat (ITT)
population and 80.0% (N=4) in the Per-Protocol (PP) population.
Both low and high doses of PDC-1421 met the primary end points by
passing the required 40% population in ADHD-RS-IV test scores.
Overall, the results from the Part 1 study demonstrated the
therapeutic value of PDC-1421 and support further clinical
development of ABV-1505 for the treatment of ADHD.
“We are pleased to see 30 subjects have been
enrolled in the Phase II Part 2 ADHD clinical trial, and 18
participants have completed the 8-week treatment,” said Dr. Howard
Doong, Chief Executive Officer of ABVC BioPharma. “We are also
delighted that the University of California, San Francisco is
involved in the Phase II Part 2 study. With UCSF participation, in
addition to the five Taiwan sites, we anticipate that enrollment
for the study will accelerate substantially, and worldwide we are
expecting to complete the Part 2 study in the third quarter of
2023.”
According to Grand View Research’s market research
report, the ADHD drug market is valued at USD 16.4 billion in
2018 and expected to reach USD 24.9 billion by 2025 with a
CAGR of 6.4% over the forecast period.[1]
[1]Grand View Research. Attention Deficit
Hyperactivity Disorder Market Size, Share & Trends Analysis
Report By Drug Type (Stimulant, Non-stimulant), By Demographic, By
Distribution Channel (Hospital & Retail Pharmacy), And Segment
Forecasts, 2019 –
2025.https://www.grandviewresearch.com/industry-analysis/attention-deficit-hyperactivity-disorder-adhd-market
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, it is focused on utilizing its
licensed technology to conduct proof-of-concept trials through
Phase II of the clinical development process at world-famous
research institutions (such as Stanford University, University of
California at San Francisco, and Cedars-Sinai Medical Center). For
Vitargus, the company intends to conduct the clinical trials
through Phase III at various locations throughout the globe.
Forward-Looking StatementsThis 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.
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.
Contact:ICR, LLC Stephanie OshchepkovPhone:
+1 (203) 682-7175Email: Stephanie.Oshchepkov@icrinc.com
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