Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage
biotechnology company advancing differentiated biologics for the
treatment of atopic dermatitis (AD), chronic obstructive pulmonary
disease and other inflammatory and immunology (I&I)
indications, today announced that it has initiated dosing of
healthy volunteers in its first clinical trial for APG777, its lead
product candidate being developed as a frontline treatment for
moderate-to-severe AD and other inflammatory diseases. Initiation
of this trial marks a milestone for the company and its approach.
By targeting known biologic drivers of disease and utilizing
advanced antibody engineering to develop product candidates with
optimized properties such as improved half-life, Apogee aims to
overcome the limitations of existing therapies for (I&I)
diseases.
“The initiation of this Phase 1 study of APG777 represents an
important advancement for Apogee, now a clinical-stage
organization, and for our discovery research collaboration with
Paragon, a pioneer in developing best-in-class biologics for a
range of diseases,” said Michael Henderson, M.D., Chief Executive
Officer of Apogee. “By leveraging known targets with differentiated
monoclonal antibodies, Apogee has the potential to improve the
course of treatment for multiple inflammatory disorders, and APG777
is just the start of our strategy to develop a broad pipeline of
potentially best-in-class product candidates. I am proud of the
Apogee team's rapid progress in advancing APG777 to this new stage,
ahead of our initial timeline expectations.”
APG777 is a novel, subcutaneous extended half-life monoclonal
antibody targeting IL-13 – a critical cytokine in inflammation and
a primary driver of AD. In head-to-head preclinical studies, APG777
demonstrated equivalent or better potency to lebrikizumab in the
inhibition of IL-13 signaling and exhibited significantly longer
half-life with the potential to deliver dosing as infrequently as
once every two to three 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.
The APG777 Phase 1 trial is a double-blind, placebo-controlled
study in healthy volunteers and consists of a single-ascending dose
(SAD) component and a multiple-ascending dose (MAD) component. The
study is expected to enroll approximately 40 healthy adult subjects
into three SAD and two MAD cohorts. The primary endpoint is safety
and a key secondary endpoint is PK. We expect initial safety and PK
data from this trial in mid-2024. Pending data from the Phase 1
trial, Apogee plans to initiate a randomized, placebo-controlled,
16-week Phase 2 clinical trial in patients with moderate-to-severe
AD in 2024.
“Apogee is focused on delivering monoclonal antibody
therapeutics with improved half-life and optimized potency,
bioavailability, and manufacturability,” said Carl Dambkowski,
M.D., Chief Medical Officer of Apogee. “APG777 is the first
realization of these engineering efforts, with highly encouraging
preclinical data that demonstrate APG777 has similar potency to
current therapies, but with significantly longer half-life that
could enable less frequent dosing. A new option providing dosing
every two or three months could be a transformative change in the
standard of care for moderate-to-severe AD patients.”
About APG777
APG777 is a novel, subcutaneous extended half-life 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 preclinical studies, Apogee believes that APG777
can be dosed either every two or every three months in maintenance,
which, if clinical trials are successful, would represent a
significant improvement compared to first generation IL-13
antibodies that are dosed every two to four weeks. A Phase 1
clinical trial of APG777 in healthy volunteers is ongoing, and the
company expects initial safety and pharmacokinetic data in
mid-2024. Pending data from the Phase 1 trial, the company
anticipates filing an IND application for a Phase 2 trial in AD,
which would begin in 2024. Based on initial clinical data, the
company may initiate a Phase 2 trial in asthma and plans to further
evaluate opportunities to develop APG777 for other I&I
indications, including alopecia areata (AA), chronic rhinosinusitis
with nasal polyps (CRSwNP), chronic spontaneous urticaria (CSU),
eosinophilic esophagitis (EoE) and prurigo nodularis (PN).
About Paragon Collaboration
In February 2022, Apogee entered into an antibody discovery
option and license agreement with Paragon Therapeutics, Inc.
(Paragon). As part of the agreement, Paragon identifies, evaluates
and develops antibodies directed against certain mutually agreed
therapeutic targets of interest to Apogee. The collaboration
currently includes three selected targets, IL-13, IL-4Rα, and
OX40L. Apogee has exercised its option for each research program
and has been granted an exclusive, worldwide license to develop,
manufacture and commercialize the antibodies and products directed
to the selected targets. From time to time, Apogee can choose to
add additional targets to the collaboration by mutual agreement
with Paragon.
About Apogee
Apogee Therapeutics is a clinical-stage biotechnology company
seeking to develop differentiated biologics for the treatment of
atopic dermatitis (AD), chronic obstructive pulmonary disease
(COPD) 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.
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, 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 APG777, and potential additional indications for
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 Registration
Statement on Form S-1, as amended, declared effective by the SEC on
July 13, 2023, 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 Contacts:
Noel KurdiVP, Investor RelationsApogee
TherapeuticsNoel.Kurdi@apogeetherapeutics.com
Monique AllaireTHRUST Strategic
Communicationsmonique@thrustsc.com
Media Contact:
Dan Budwick1AB Mediadan@1abmedia.com
Apogee Therapeutics (NASDAQ:APGE)
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