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, today
announced the poster presentation at the 53rd Child Neurology
Society (CNS) Annual Meeting of safety data from its prior Phase 3
ATTeST (Ataxia-Telangiectasia Trial with the
EryDex SysTem; #IEDAT-02-2015/NCT02770807)
clinical trial. The objective of the data analysis was to evaluate
treatment-emergent adverse events (TEAEs) in patients with
Ataxia-Telangiectasia (A-T) treated with the company’s lead asset,
EryDex (intra-erythrocyte dexamethasone sodium phosphate), for one
year compared to placebo control.
Key findings reported in the poster presentation, titled
Treatment-Emergent Adverse Events (TEAEs) in Children With
Ataxia-Telangiectasia Treated for One Year With Intra-Erythrocyte
Dexamethasone Sodium Phosphate (EryDex), include:
- EryDex treatment was generally well tolerated with most TEAEs
being mild to moderate and transient, and generally similar between
EryDex- and placebo-treated patients.
- Side effects typically attributed to chronic steroid use, such
as Cushingoid features, hyperglycemia, hirsutism, or hypertension,
were not observed.
- Three patients were discontinued from the study: one patient in
the low-dose group had a serious adverse event (SAE) of B-cell
lymphoma (unlikely treatment related) and two patients in the
high-dose group had TEAEs of pyrexia and tachycardia (one patient,
probably treatment related) and pain and pruritus (one patient,
possibly treatment related).
- There were no TEAEs leading to death.
Dirk Thye, M.D., Quince’s Chief Executive Officer and Chief
Medical Officer, said, “Results from the ATTeST study, including
the emerging safety profile of intra-erythrocyte dexamethasone
treatment, suggest that EryDex may be a promising therapy for
patients with A-T and should be further evaluated for potential
investigational treatment for patients requiring chronic steroid
use. We are pleased to advance EryDex treatment in our pivotal
Phase 3 NEAT study, currently enrolling patients with A-T in the
U.S. and in Europe, with topline results expected in the fourth
quarter of 2025.”
Pivotal Phase 3 NEAT Clinical Trial
Quince is currently enrolling a pivotal Phase 3 NEAT
(Neurologic Effects of EryDex on Subjects with
A-T; #IEDAT-04-2022/NCT06193200) clinical trial,
which is an international, multi-center, randomized, double-blind,
placebo-controlled clinical trial evaluating the neurological
effects of EryDex treatment in patients with A-T. The company 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.
The Phase 3 NEAT trial is being conducted under a Special
Protocol Assessment (SPA) agreement with the U.S. Food and Drug
Administration (FDA), and the company expects to report topline
results in the fourth quarter of 2025 with a potential 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.
Additionally, Quince was granted Fast Track designation by the FDA
for the company’s EryDex System for the treatment of patients with
A-T based on the potential for EryDex to address a high unmet
medical need in A-T.
About Ataxia-Telangiectasia
A-T is an inherited autosomal recessive neurodegenerative and
immunodeficiency disorder caused by mutations in the ATM gene,
which is responsible for cell homeostatic and cell division
functions including but not limited to double-stranded DNA repair.
Typically, A-T is first diagnosed before the age of five as
children begin to develop an altered gait and fall with greater
frequency. Neurological symptoms worsen and patients with A-T
frequently become wheelchair-bound by adolescence. Teenage years
for patients with A-T are typically marked by repeated infections,
pulmonary impairment, and malignancies. The median lifespan is
approximately 25 to 30 years old with mortality due to infections
and malignancy. Based on IQVIA Medical Claims (Dx), PharmetricsPlus
(P+), and IQVIA Analytics information, there are approximately
4,600 diagnosed patients with A-T in the U.S. Quince estimates that
there are approximately 5,000 patients with A-T in the U.K. and EU4
countries. There are currently no approved therapeutic treatments
in any global market for A-T.
About EryDex for A-T
The EryDex System is a drug/device combination product comprised
of dexamethasone sodium phosphate (DSP) which is encapsulated and
administered using a patient’s own red blood cells (autologous
erythrocytes). DSP is a corticosteroid well known for its
anti-inflammatory properties as well as its dose-limiting toxicity
due to adrenal suppression. The EryDex System is designed to
provide the efficacy of corticosteroids and to reduce or eliminate
the significant adverse effects that accompany chronic use of
corticosteroid treatment.
EryDex leverages Quince’s proprietary Autologous
Intracellular Drug Encapsulation (AIDE)
technology platform that uses an automated process designed to
encapsulate and administer a drug using the patient’s own red blood
cells. Red blood cells have several characteristics that make them
a potentially effective vehicle for drug delivery, including
potentially better tolerability, enhanced tissue distribution,
reduced immunogenicity, and prolongation of circulating half-life.
Quince’s AIDE technology is designed to harness these benefits to
allow for the chronic administration of drugs that have limitations
due to toxicity, poor biodistribution, suboptimal pharmacokinetics,
or immune response.
About Quince Therapeutics
Quince Therapeutics (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 Therapeutics 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 current and future clinical
development of EryDex, including for the potential treatment of
Ataxia-Telangiectasia (A-T) and other potential indications,
related development and commercial-stage inflection point for
EryDex, the company’s proprietary Autologous Intracellular Drug
Encapsulation (AIDE) technology for treatment of other rare
diseases; the strategic development path for EryDex; planned
regulatory agency submissions and clinical trials and timeline,
prospects, and milestone expectations; the timing and success of
the clinical trials and related data, including plans and the
ability to initiate, fund, enroll, conduct, and/or complete current
and additional studies; the company’s future development plans and
related timing; the company’s focus, objectives, plans, and
strategies; and the potential benefits of EryDex, AIDE technology
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 August 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/20241111594081/en/
Media & Investor Contact: Stacy Roughan Quince
Therapeutics, Inc. Vice President, Corporate Communications &
Investor Relations ir@quincetx.com
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