Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage
biotechnology company advancing differentiated biologics for the
treatment of atopic dermatitis (AD), chronic obstructive pulmonary
disease (COPD), asthma and other inflammatory and immunology
(I&I) indications, today announced that it has initiated dosing
in the Phase 2 trial of APG777 in patients with moderate-to-severe
atopic dermatitis. APG777 is a novel, subcutaneously-administered
half-life extended monoclonal antibody targeting IL-13 – a critical
cytokine in inflammation and a primary driver of AD.
“We are thrilled to begin patient dosing in our Phase 2 trial of
APG777, marking a significant step forward in the advancement of
this program and to further realizing the impact a fully-optimized
antibody with extended half-life could have on the treatment of AD
compared to other available biologics,” said Michael Henderson, MD,
Chief Executive Officer of Apogee. “The initiation of this Phase 2
trial is supported by the highly encouraging results of our Phase 1
healthy volunteer trial that were reported earlier this year. With
a potentially best-in-class pharmacokinetic profile, sustained
pharmacodynamic responses, and well-tolerated safety profile, we
believe APG777 could offer improved clinical responses with less
frequent dosing than current standard of care. We look forward to
the advancement of this trial and initial 16-week data in the
second half of 2025.”
The APG777 Phase 2 clinical trial is a randomized,
placebo-controlled, 16-week trial in patients with
moderate-to-severe AD. The trial was designed to combine the
typical Phase 2a and 2b portions of a clinical trial into a single
protocol. Part A is expected to enroll approximately 110 patients
randomized 2:1 to APG777 vs. placebo; patients receiving APG777
will receive induction regimen dosing of 720mg at weeks 0 and 2,
followed by 360mg at weeks 4 and 12. Patients benefiting from
treatment will continue to APG777 maintenance, which will evaluate
3- to 6-month dosing. Part B is a placebo-controlled dose
optimization with approximately 360 patients randomized 1:1:1:1 to
high, medium, or low dose APG777 vs. placebo. The primary endpoint
of each part of the study is mean percentage changes in EASI score
from baseline to Week 16.
In head-to-head preclinical studies, APG777 demonstrated
equivalent or better potency to lebrikizumab in the inhibition of
IL-13 signaling. Based on its potentially best-in-class
pharmacokinetic (PK) profile, APG777 has the potential for improved
clinical responses due to greater exposures of drug in induction
while dosing as infrequently as once every three or six months. AD
is a chronic inflammatory skin disorder which can lead to sleep
disturbance, psychological distress, elevated infection risk and
chronic pain, all of which significantly impact quality of life.
Today’s treatments are associated with many challenges, including
frequent injection regimens that can lead to poor patient
compliance.
“Our Phase 2 trial features an innovative design, enabling us to
run both proof-of-concept and dose optimization parts in the same
study, which could significantly accelerate our timelines,” said
Carl Dambkowski, MD, Chief Medical Officer of Apogee. “Importantly,
based on APG777’s extended half-life and high-concentration
formulation, we were able to establish a Phase 2 induction regimen
designed to exceed lebrikizumab exposures by ~30-40% with potential
for improved clinical responses (e.g. EASI-75, EASI-90, IGA 0/1).
The optimized PK profile will further enable a dosing schedule of
six injections during induction, compared to the 11 injections of
lebrikizumab given during the same period, and ~70-90% fewer
injections in maintenance compared to currently available
therapies. This approach supports our mission to provide
well-tolerated treatments that require less frequent injections for
patients. We extend our gratitude to the sites, site staff, and
patients participating in the study for their invaluable
contributions to advancing our program and look forward to further
realizing the impact that less frequent dosing and a potentially
improved clinical response could bring to patients living with
AD.”
About APG777APG777 is a novel, subcutaneous
half-life extended monoclonal antibody targeting IL-13 for the
potential treatment of atopic dermatitis (AD). In head-to-head
preclinical studies, APG777 showed equivalent or better potency to
lebrikizumab in the inhibition of IL-13 signaling. AD is a chronic
inflammatory skin disorder that affects approximately 40 million
adults and 18 million children in the United States, France,
Germany, Italy, Japan, Spain and the United Kingdom, 40 percent of
which have moderate-to-severe disease. Based on initial clinical
data, the company plans to initiate a Phase 2 trial in asthma and
plans to further evaluate opportunities to develop APG777 for other
I&I indications, including alopecia areata, chronic
rhinosinusitis with nasal polyps, chronic spontaneous urticaria,
eosinophilic esophagitis and prurigo nodularis.
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 Statements Certain statements
in this press release may constitute “forward-looking statements”
within the meaning of the federal securities laws, including, but
not limited to, statements regarding: the efficacy, safety,
tolerability, PK and PD profile of APG777, the potential dosing
regimen of APG777, the potential superiority of APG777 compared to
current therapies, our expectations regarding plans for our current
and future product candidates and programs, our plans for our
current and future clinical trials, including our Phase 2 trial for
APG777, our plans for clinical trial design, the anticipated timing
of the initiation of and results from our clinical trials,
including data from our Phase 2 trial of AP777, and the potential
clinical benefit and half-life of APG777. 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 identified in
our Quarterly Report on 10-Q for the quarterly period ended March
31, 2024, filed with the SEC on May 13, 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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