Phase 3 NEAT clinical trial nearing 50%
enrollment; company reiterates expectation of enrollment completion
in second quarter of 2025 and topline results in fourth quarter of
2025
Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage
biotechnology company dedicated to unlocking the power of a
patient’s own biology for the treatment of rare diseases, announced
that it will host an investor webinar today, Friday, February 7,
2025, beginning at 10:00 a.m. Eastern Time, featuring key opinion
leader (KOL) Dr. Mary Kay Koenig from UTHealth Houston with a
discussion focused on addressing the high unmet need in
Ataxia-Telangiectasia (A-T).
Quince also disclosed that the company has enrolled 46
participants to date in its pivotal Phase 3 NEAT (Neurologic
Effects of EryDex on Subjects with A-T;
NCT06193200 / IEDAT-04-2022) clinical trial to evaluate the
neurological effects of EryDex in patients with A-T.
Dirk Thye, M.D., Quince’s Chief Executive Officer and Chief
Medical Officer, said, “We continue to make significant progress
with clinical site activations and enrollment of our pivotal Phase
3 NEAT clinical trial. With 61 participants screened to date,
enrollment is nearing 50% and we expect screening and randomization
to accelerate in the coming weeks due to several new geographic
regions and sites scheduled for activation. We anticipate
completing enrollment during the second quarter of 2025 and
reporting topline results before the end of 2025.”
Pivotal Phase 3 NEAT Clinical Trial
- Enrolled 46 participants to date in the company’s Phase 3 NEAT
clinical trial to evaluate the neurological effects of EryDex in
patients with A-T, including 40 participants in the six to nine
year-old primary analysis population. Quince plans to enroll
approximately 86 patients with A-T ages six to nine years old
(primary analysis population) and approximately 20 patients with
A-T ages 10 years or older.
- Open label extension initiated with 17 participants rolling
over to date in the U.S., U.K., and European Union. Participants
who complete the full treatment period, complete study assessments,
and provide informed consent are eligible to transition to an open
label extension study.
- Pivotal Phase 3 NEAT clinical trial is being conducted under a
Special Protocol Assessment (SPA) agreement with the U.S. Food and
Drug Administration (FDA).
- Expect to report Phase 3 NEAT topline results in the fourth
quarter of 2025 with a New Drug Application (NDA) submission to the
FDA and a Marketing Authorization Application (MAA) submission to
the European Medicines Agency (EMA) in 2026, assuming positive
study results.
- NEAT is an international, multi-center, randomized,
double-blind, placebo-controlled study to evaluate the neurological
effects of the company’s lead asset, EryDex (dexamethasone sodium
phosphate [DSP] encapsulated in autologous red blood cells), in
patients with A-T.
- Participants will be randomized (1:1) between EryDex or placebo
and treatment will consist of six infusions scheduled once every 21
to 30 days. The primary efficacy endpoint will be measured by the
change from baseline to last visit completion in a rescored
modified International Cooperative Ataxia Rating Scale (RmICARS)
compared to placebo as per the SPA agreement with the FDA.
Join Today’s A-T KOL Investor Webinar
Quince will host an investor webinar today focused on addressing
the high unmet need in the company’s lead rare pediatric
neurodegenerative disease indication, Ataxia-Telangiectasia (A-T),
today, Friday, February 7, 2025, beginning at 10:00 a.m. Eastern
Time.
The webinar will feature leading A-T KOL Mary Kay Koenig, M.D.,
who will: 1) provide an A-T natural history overview, 2) detail
current symptomatic treatment approaches for patients with A-T, 3)
discuss the competitive therapeutic A-T landscape, and 4) provide
an overview of Quince’s Phase 3 clinical trial of EryDex for the
treatment of A-T. Dirk Thye, M.D., Quince’s Chief Executive Officer
and Chief Medical Officer, will join the discussion to provide a
corporate and scientific overview, as well as an enrollment update
on the company’s ongoing Phase 3 NEAT clinical trial.
Mary Kay Koenig, M.D., is a board certified child neurologist
specializing in neurodegenerative disorders, including A-T,
mitochondrial disease, and tuberous sclerosis complex. She
currently serves as a Professor and Associate Vice-Chair for
Clinical Research in the Department of Pediatrics, Division of
Child and Adolescent Neurology at the McGovern Medical School at
the University of Texas, Houston. Dr. Koenig is also an Endowed
Chair of Mitochondrial Medicine at the McGovern Medical School at
the University of Texas, Houston, in addition to serving as a
Director at the Center for the Treatment of Pediatric
Neurodegenerative Disease and a Co-Director of the Tuberous
Sclerosis Center within the UTHealth Houston system – one of the
nation’s most comprehensive academic health science centers. She
strives to provide excellent clinical care and advance research for
children afflicted with genetic neurodegenerative disease. Dr.
Koenig also works to mentor and educate junior faculty, fellows,
residents, and medical students in the art of medicine and clinical
research. She received her M.D. from St. George’s University School
of Medicine and completed her pediatrics residency at the
University of Texas Medical Branch in Galveston, Texas, in addition
to a fellowship in child and adolescent neurology at the University
of Texas Medical School in Houston, Texas.
To register for this webinar, please click here. A live webcast
of the presentation will be accessible on Quince’s Events page
under the News & Events heading of the company’s Investor
Relations website at ir.quincetx.com. An archive of the webcast
will be available shortly following the end of the live event.
About Quince Therapeutics
Quince Therapeutics, Inc. (Nasdaq: QNCX) is a late-stage
biotechnology company dedicated to unlocking the power of a
patient’s own biology for the treatment of rare diseases. For more
information on the company and its latest news, visit
www.quincetx.com and follow Quince on social media platforms
LinkedIn, Facebook, X, and YouTube.
Forward-looking Statements
Statements in this news release contain “forward-looking
statements” within the meaning of the Private Securities Litigation
Reform Act of 1995 as contained in Section 27A of the Securities
Act of 1933, as amended, and Section 21E of the Securities Exchange
Act of 1934, as amended, which are subject to the “safe harbor”
created by those sections. All statements, other than statements of
historical facts, may be forward-looking statements.
Forward-looking statements contained in this news release may be
identified by the use of words such as “believe,” “may,” “should,”
“expect,” “anticipate,” “plan,” “believe,” “estimated,”
“potential,” “intend,” “will,” “can,” “seek,” or other similar
words. Examples of forward-looking statements include, among
others, statements relating to the timing, success, and reporting
of results of the clinical trials and related data, including plans
and the ability to enroll, conduct, and/or complete current and
additional studies; current and future clinical development of
EryDex, including for the potential treatment of
Ataxia-Telangiectasia (A-T) and other potential indications; the
strategic development path for EryDex; planned regulatory agency
submissions and clinical trials and timeline, prospects, and
milestone expectations; and the potential benefits of EryDex and
the company’s market opportunity. Forward-looking statements are
based on Quince’s current expectations and are subject to inherent
uncertainties, risks, and assumptions that are difficult to predict
and could cause actual results to differ materially from what the
company expects. Further, certain forward-looking statements are
based on assumptions as to future events that may not prove to be
accurate. Factors that could cause actual results to differ
include, but are not limited to, the risks and uncertainties
described in the section titled “Risk Factors” in the company’s
Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission (SEC) on November 13, 2024, and other reports
as filed with the SEC. Forward-looking statements contained in this
news release are made as of this date, and Quince undertakes no
duty to update such information except as required under applicable
law.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20250207587017/en/
Media & Investor Contact: Stacy Roughan Quince
Therapeutics, Inc. Vice President, Corporate Communications &
Investor Relations ir@quincetx.com
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