ABVC BioPharma Announces Completion of Subject Recruitment for Interim Analysis on ADHD Phase IIb Clinical Study
17 Ottobre 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 IIb clinical study taking place at the
University of California San Francisco (UCSF) Medical Center and
five Taiwanese medical centers. Sixty-nine subjects enrolled in the
study, 50 completed the study, and 11 are currently undergoing
treatment.
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. "We received a favorable
response from the subjects participating in our ADHD Phase IIb
study at all of our sites," said ABVC BioPharma Chief Executive
Officer Uttam Patil, Ph. D. "To reach an interim analysis, the
study requires 69 patients' data. Our clinical trials continue to
demonstrate that medicine derived from plants can have significant
therapeutic benefits, often with few - if any - side effects. We
expect to report similar results in our interim analysis
report." 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 clinical trials through Phase III.
Forward-Looking Statements This 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 Masterson
Email: tmasterson@allelecomms.com
[1] https://www.polarismarketresearch.com/industry-analysis/attention-deficit-hyperactivity-disorder-market
Grafico Azioni ABVC BioPharma (NASDAQ:ABVC)
Storico
Da Apr 2024 a Mag 2024
Grafico Azioni ABVC BioPharma (NASDAQ:ABVC)
Storico
Da Mag 2023 a Mag 2024