Full Press Release Details
Apogee Therapeutics Highlights Progress and
Best-in-Class Potential of Novel Biologic Programs for I&I Diseases at 2024 Inaugural R&D Day
Positive interim Phase 1 data indicate APG808
was well-tolerated with half-life of approximately 55 days, supporting potential for 2- to 3- month dosing and demonstrating deep and
sustained inhibition of biomarkers
Data up to 12 months reinforce APG777's
best-in-class potential, including 77-day half-life, and provide a potential path to annual dosing
16-week topline data from APG777 Phase 2 Part A
trial in AD accelerated to mid-2025 based on strong enrollment
Preclinical and coformulation proof-of-concept
achieved for APG777 + APG990 combination Phase 1b head-to-head trial against DUPIXENT expected to initiate in 2025 with data in 2H 2026
Preclinical proof-of-concept achieved for APG777
+ APG333 combination in asthma and COPD, clinical trial planning underway
Webcast to be held today at 10:00 a.m. ET
SAN FRANCISCO and WALTHAM, Mass., December 2,
2024 -- Apogee Therapeutics, Inc., (Nasdaq: APGE), a clinical-stage biotechnology company advancing novel biologics with potential
for differentiated efficacy and dosing in the largest inflammatory and immunology (I&I) markets, including for the treatment of atopic
dermatitis (AD), asthma, chronic obstructive pulmonary disease (COPD), eosinophilic esophagitis (EoE) and other I&I indications, will
highlight updates from across its pipeline during today's Virtual R&D Day, being held at 10:00 a.m. ET. Updates include
positive interim results from the APG808 Phase 1 trial, data up to 12 months from the APG777 Phase 1 trial, details around the Company's
strategy for combinations in AD, asthma and COPD to deliver better efficacy and dosing regimens, and the expected significant commercial
potential of its programs. Key opinion leaders, Emma Guttman-Yassky, M.D., Ph.D. and David Singh, M.D., FERS, FBPhS, will also discuss
the current landscape and need for new treatment opportunities for patients living with I&I conditions.
"APG777 is poised to disrupt the atopic dermatitis
market, with our most recent data suggesting potential dosing as infrequently as once per year -- a revolutionary advancement that has
garnered positive feedback from patients, physicians and payers alike," said Michael Henderson, M.D., Chief Executive Officer of
Apogee. "We plan on transforming the standard of care in I&I through
three waves of innovation: progressing APG777's monotherapy program with potential for higher efficacy and transformational dosing
in AD, currently in a Phase 2 Part A 16-week trial, with its proof of concept (PoC) readout that has been accelerated to mid-2025
based on strong enrollment; demonstrating APG777's pipeline-in-a-product
monotherapy potential by expanding into EoE as well as asthma; and advancing the first AD combination PoC trial next year with respiratory
combo planning underway. Beyond its differentiation as a monotherapy, APG777 combined with APG990 as well as with APG333 presents
the opportunity for enhanced efficacy and best-in-class dosing for patients."
"We're pleased to report positive
safety, PK and PD data from the Phase 1 healthy volunteer trial of APG808 at today's R&D Day," said Carl Dambkowski, M.D.,
Chief Medical Officer of Apogee. "Our interim findings demonstrated an approximately 55-day half-life for APG808, a five-fold increase
versus DUPIXENT, suggesting a potential dosing regimen of every 2- to 3-months, compared to every 1-2 weeks for DUPIXENT. We believe the
results support Apogee's ability to engineer optimized antibodies and target known biologic drivers to improve the lives of patients
with I&I conditions. We look forward to further evaluating APG808 in the Phase 1b trial in asthma as well as delivering data on additional
pipeline candidates next year."
APG808 interim Phase 1 healthy volunteer trial
The APG808 Phase 1 trial enrolled 32 healthy adult
participants into four single-ascending dose (SAD) cohorts. Today, Apogee shared interim data from all four SAD cohorts with at least
Accelerating a leading franchise in AD
Apogee is advancing multiple opportunities for
best-in-class monotherapy and first-in-class combination approaches for the treatment of AD that could provide transformational dosing
and efficacy compared to current approved and investigational biologics.
APG777 is a novel, subcutaneous (SQ) extended
half-life monoclonal antibody (mAb) targeting IL-13 with the potential for best-in-class efficacy and dosing compared to currently approved
biologics. APG777 is being evaluated in an ongoing Phase 1 trial, which initiated in August 2023, and a global Phase 2 trial in AD,
which initiated in May 2024.
Raising the bar in AD and beyond via broader
plans to take a first-in-class combination approach to AD by targeting Types 1-3 inflammation potentially offering JAK-like inhibition
without their associated safety concerns. This approach offers the potential for improved clinical responses over monotherapies
and best-in-class dosing.
APG990 is a novel, SQ half-life extended mAb targeting
OX40L, initially being developed for AD. OX40L is located further upstream in the inflammatory pathway than IL-13 and targeting it could
have broader impact on the inflammatory cascade by inhibiting Type 1, Type 2 and Type 3 pathways. Apogee is evaluating APG990 in a Phase
1 healthy volunteer trial to establish safety, tolerability and PK profile, which would enable combination with APG777.
Breaking through the efficacy ceiling in asthma
Apogee plans to take a combination approach to
the treatment of asthma and COPD, leveraging mechanisms that address both central and local drivers of respiratory diseases, potentially
enabling enhanced efficacy and extended dosing regimens.
APG333 is a novel, SQ extended half-life mAb targeting
TSLP, a key driver of Type 2 and Type 3 inflammation in eosinophilic and non-eosinophilic conditions. A Phase 1 trial in healthy volunteers
is planned to commence by the end of 2024, with data expected in the second half of 2025.
Apogee Therapeutic's Virtual R&D Day
will begin at 10:00 a.m. ET. The live webcast can be accessed via this link or News & Events page in
the Investors section of the Apogee Therapeutics website. A replay of the webcast will be archived on the website following the event.
It is recommended that participants register at least 15 minutes in advance of the event.
Apogee Therapeutics is a clinical-stage biotechnology
company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, including for
the treatment of AD, asthma, COPD, EoE and other I&I indications. 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. APG777, the company's most advanced program, is being initially developed for the treatment of
AD, which is the largest and one of the least penetrated I&I markets. With four validated targets in its portfolio, Apogee is seeking
to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. 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 https://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: Apogee's plans for its current and future product candidates and programs, particularly APG777, APG990 and
APG333; its plans for current and future clinical trials; expected timing for release of data from Apogee's APG808 Phase 1b trial,
Part A of the APG777 Phase 2 trial and APG333 Phase 1 trial; the potential clinical benefit, dosing schedule and half-life of APG777
and APG808; plans for and potential benefit of Apogee's other product candidates, and any other potential programs, including combination
therapies. 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 Apogee's preclinical studies, clinical trials
and research and development programs; expectations regarding the timing, completion and outcome of Apogee's 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 Apogee's Annual Report on Form 10-K
for the year ended December 31, 2023, filed with the SEC on March 5, 2024, Quarterly Report on 10-Q for the quarterly period