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
the online publication of safety data from patients with
Ataxia-Telangiectasia (A-T) treated with EryDex for a minimum of 24
months in Frontiers in Neurology.
“A-T is a rare pediatric disease with unmet medical need and no
approved therapeutic treatment. This post-hoc analysis of patients
with A-T treated for a minimum of 24 months in a Phase 3 clinical
trial (ATTeST) and an open label extension study, provides data
supporting the potential to deliver dexamethasone sodium phosphate
encapsulated in a patient’s own red blood cells using our EryDex
System without the chronic debilitating toxicities observed with
standard corticosteroid treatment,” said Dirk Thye, M.D., Quince’s
Chief Executive Officer and Chief Medical Officer. “Adverse events
typically observed with prolonged corticosteroid use such as
Cushingoid features, weight gain, hypertension, hirsutism,
diabetes, or stunted growth were rarely reported in these studies.
With more than 6,000 monthly doses administered to nearly 400
patients over the last 10-plus years, we are building a strong
safety database as our pivotal Phase 3 clinical trial (NEAT) and
its open label extension study continue.”
Frontiers in Neurology Publication Highlights
The Frontiers in Neurology publication entitled Long-term
safety of dexamethasone sodium phosphate encapsulated in autologous
erythrocytes in pediatric patients with Ataxia-Telangiectasia
describes the safety of long-term use of EryDex in treatment of
pediatric patients with A-T.
Highlights include:
- EryDex is dexamethasone sodium phosphate (DSP) encapsulated in
autologous erythrocytes that has been developed in an effort to
address chronic steroid toxicity while maintaining efficacy.
- Results include analyses of data from patients with A-T treated
with EryDex for a minimum of 24 months.
- Analyses included treatment-emergent and treatment-related
adverse events, serious adverse events, and adverse events of
special interest.
- The most common treatment-related adverse event was transient
infusion-related pruritus, which is the most common steroid related
side effect, and low serum iron levels, which are not associated
with negative clinical outcomes.
- Adverse events typically observed with prolonged glucocorticoid
use such as Cushingoid features, weight gain, hypertension,
hirsutism, diabetes, or stunted growth were infrequently reported
over 24 to 61 months of dosing.
- There was a decline in bone mineral density (BMD) of 0.4 z
scores over the two-year period – which could not be distinguished
from the natural course of disease in patients with A-T.
- There were no reported adverse effects on height, weight and
body mass index as supported by stable z-scores throughout the two
years of treatment.
- Values for glucose, HbA1c, cortisol, and CD4+ lymphocyte counts
did not show clinically significant changes during prolonged
treatment with EryDex.
Quince is currently enrolling the pivotal Phase 3 NEAT clinical
trial (#IEDAT-04-2022/NCT06193200), which is an international,
multi-center, randomized, double-blind, placebo-controlled clinical
trial evaluating the neurological effects of EryDex in patients
with A-T. 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.
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 treatment of patients with A-T based on the potential 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
EryDex is comprised of dexamethasone sodium phosphate (DSP)
encapsulated in 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, or AIDE, technology platform, which is a novel
drug/device combination that uses an automated process designed to
encapsulate a drug into 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, 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 current and future clinical
development of EryDex, including for the potential treatment of
Ataxia-Telangiectasia (A-T), Duchenne muscular dystrophy (DMD), and
other potential indications, related development and
commercial-stage inflection point for EryDex, and expansion of 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, success, and reporting of
results 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 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/20250127038684/en/
Media & Investor Contact: Stacy Roughan Quince
Therapeutics, Inc. Vice President, Corporate Communications &
Investor Relations ir@quincetx.com
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