Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage
biotechnology company advancing differentiated biologics for the
treatment of atopic dermatitis (AD), COPD, asthma and other
inflammatory and immunology (I&I) indications, today announced
that it has initiated dosing of healthy volunteers in its first
clinical trial for APG808, a novel subcutaneous (SQ) extended
half-life monoclonal antibody (mAb) targeting IL-4Rα, which is
being developed as a treatment for people living with
moderate-to-severe COPD, asthma and other I&I diseases.
“On the heels of announcing positive interim data from our Phase
1 APG777 clinical trial, the initiation of the APG808 Phase 1
healthy volunteer trial represents another important advancement
for Apogee’s portfolio of differentiated and optimized biologics,”
said Michael Henderson, M.D., Chief Executive Officer of Apogee.
“Launching our second clinical program, ahead of initial timeline
expectations, brings us one step closer to providing potentially
best-in-class biologics designed to significantly improve
therapeutic options for patients with I&I diseases and further
builds our track record of execution.”
APG808 is a novel, SQ extended half-life mAb targeting IL-4Rα, a
target with clinical validation across eight Type 2 allergic
diseases. APG808 has similar binding and femtomolar affinity for
IL-4Rα as compared to a first-generation mAb, DUPIXENT, and has
demonstrated similar inhibition to DUPIXENT across three in vitro
assays, which measure downstream functional inhibition of the
IL-13/IL-4 pathway (pSTAT6 induction, inhibition of TF-1
proliferation, and inhibition of TARC secretion). COPD is a
progressive respiratory disease that is estimated to affect
approximately 10 percent of the global population 40 years of age
and older. Despite recent advancements in COPD treatment, a
significant number of people continue to suffer and die from the
disease.
The APG808 Phase 1 trial is designed as a double-blind,
placebo-controlled, first-in-human, single-ascending dose trial in
healthy volunteers. The study will evaluate the safety,
tolerability and pharmacokinetics (PK) of APG808 and is expected to
enroll approximately 32 healthy adults into four cohorts. Apogee
expects interim data from the trial in the second half of 2024,
and, pending positive results from the Phase 1 trial and following
the submission of an IND or foreign equivalent, plans to initiate a
potential Phase 1b trial in asthma with a data readout in the first
half of 2025 and a randomized, placebo-controlled Phase 2 clinical
trial in patients with moderate-to-severe COPD in 2025.
“By targeting known biologic drivers of disease and utilizing
advanced antibody engineering such as improved half-life, Apogee
aims to overcome limitations of existing therapies for I&I
diseases,” said Carl Dambkowski, M.D., Chief Medical Officer of
Apogee. “We demonstrated the potential benefits of optimizing
antibody properties with APG777 and now hope to do the same with
APG808, which, in head-to-head preclinical studies, demonstrated
similar potency to current therapies but with a significantly
longer half-life. Importantly, this points to potentially less
frequent dosing for patients with COPD, which could significantly
improve quality of life.”
About APG808APG808 is a novel, subcutaneous
extended half-life monoclonal targeting IL-4Rα, a target with
clinical validation across eight Type 2 allergic diseases, for the
potential treatment of chronic obstructive pulmonary disease
(COPD), asthma and other inflammatory and immunology indications.
APG808 has similar binding and femtomolar affinity for IL-4Rα as
compared to a first generation mAb, DUPIXENT, and has demonstrated
similar inhibition to DUPIXENT across three in vitro assays which
measure downstream functional inhibition of the IL-13/IL-4 pathway
(pSTAT6 induction, inhibition of TF-1 proliferation, and inhibition
of TARC secretion). COPD is a progressive respiratory disease that
is estimated to affect approximately 10 percent of the global
population 40 years of age and older. Despite recent advancements
in COPD treatment, a significant number of people continue to
suffer and die from the disease. A Phase 1 clinical trial of APG808
in healthy volunteers is ongoing, and the company expects interim
safety and pharmacokinetic data in the second half of 2024. Pending
data from the Phase 1 trial, the company plans to initiate a
potential Phase 1b trial in asthma with a data readout in in the
first half of 2025 and a randomized, placebo-controlled Phase 2
clinical trial in patients with moderate-to-severe COPD in
2025.
About ApogeeApogee Therapeutics is a
clinical-stage biotechnology company seeking to develop
differentiated biologics for the treatment of atopic dermatitis
(AD), chronic obstructive pulmonary disease (COPD), asthma and
other inflammatory and immunology indications with high unmet need.
Apogee’s antibody programs are designed to overcome limitations of
existing therapies by targeting well-established mechanisms of
action and incorporating advanced antibody engineering to optimize
half-life and other properties. The company’s two most advanced
programs are APG777 and APG808, which are being initially developed
for the treatment of AD and COPD, respectively. Based on a broad
pipeline and depth of expertise, the company believes it can
deliver value and meaningful benefit to patients underserved by
today’s standard of care. For more information, please visit
www.apogeetherapeutics.com.
Forward Looking StatementsCertain statements in
this press release may constitute “forward-looking statements”
within the meaning of the federal securities laws, including, but
not limited to, our expectations regarding plans for our current
and future clinical trials, plans for clinical trial design, the
anticipated timing of the initiation of and results from our
clinical trials, potential clinical benefit and half-life of
APG808, and potential additional indications for APG808 and our
other programs. Words such as “may,” “might,” “will,” “objective,”
“intend,” “should,” “could,” “can,” “would,” “expect,” “believe,”
“design,” “estimate,” “predict,” “potential,” “develop,” “plan” or
the negative of these terms, and similar expressions, or statements
regarding intent, belief, or current expectations, are
forward-looking statements. While Apogee believes these
forward-looking statements are reasonable, undue reliance should
not be placed on any such forward-looking statements, which are
based on information available to the company on the date of this
release. These forward-looking statements are based upon current
estimates and assumptions and are subject to various risks and
uncertainties (including, without limitation, those set forth in
Apogee’s filings with the U.S. Securities and Exchange Commission
(the SEC)), many of which are beyond the company’s control and
subject to change. Actual results could be materially different.
Risks and uncertainties include: global macroeconomic conditions
and related volatility, expectations regarding the initiation,
progress, and expected results of our preclinical studies, clinical
trials and research and development programs; expectations
regarding the timing, completion and outcome of our clinical
trials; the unpredictable relationship between preclinical study
results and clinical study results; the timing or likelihood of
regulatory filings and approvals; liquidity and capital resources;
and other risks and uncertainties, including those risks described
in “Risk Factors” and “Management’s Discussion and Analysis of
Financial Condition and Results of Operations” in our Annual Report
on Form 10-K for the year ended December 31, 2023, filed with the
SEC on March 5, 2024, and subsequent disclosure documents we may
file with the SEC. Apogee claims the protection of the Safe Harbor
contained in the Private Securities Litigation Reform Act of 1995
for forward-looking statements. Apogee expressly disclaims any
obligation to update or alter any statements whether as a result of
new information, future events or otherwise, except as required by
law.
Investor Contact:Noel KurdiVP, Investor
RelationsApogee Therapeutics,
Inc.Noel.Kurdi@apogeetherapeutics.com
Media Contact:Dan Budwick1AB
dan@1abmedia.com
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