SAN FRANCISCO and BOSTON, May 01, 2025 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc., (Nasdaq: APGE), today announced that members of management will present at the Bank of America Health Care Conference on Tuesday, May 13, 2025, at 1:40 p.m. P.T. / 4:40 p.m. E.T. A live and archived webcast of the presentation will be available via the News & Events page in the Investors section of the Apogee Therapeutics website. About Apogee Apogee Therapeutics is a clinical-stage biotechnology company advancing novel b ...

On Monday, Apogee Therapeutics, Inc. APGE released interim Phase 1 results from its first-in-human trial of APG990.APG990 interim Phase 1 pharmacokinetic (PK) data showed a half-life of approximately 60 days across doses tested.Key data from the 40-healthy subject trial showed:APG990 demonstrated a potential best-in-class PK profile, including a half-life of approximately 60 days, supporting the potential for every three- and six-month maintenance dosing. The PK profile supports the potential for a single 2 ...

Core Insights - Apogee Therapeutics is advancing its clinical pipeline, particularly focusing on APG777 for atopic dermatitis (AD) and APG279, a combination therapy with APG990, with significant milestones achieved ahead of schedule [1][2][3] Pipeline Progress - The Phase 2 APEX clinical trial for APG777 has seen over-enrollment in Part A and the initiation of Part B ahead of schedule, with topline data expected by mid-2025 [1][2] - APG279, which combines APG777 and APG990, is set to enter a Phase 1b head-to-head study against DUPIXENT, with interim results anticipated in the second half of 2026 [1][3] - APG777 is a novel monoclonal antibody targeting IL-13, showing a half-life of 77 days and near complete inhibition of pSTAT6 for up to 12 months after a single dose [3] Financial Position - As of December 31, 2024, Apogee reported cash, cash equivalents, and marketable securities totaling $731.1 million, providing a runway into Q1 2028 [1][4] - Research and development expenses for 2024 were $167.9 million, significantly up from $68.4 million in 2023, reflecting ongoing clinical trials and expansion of the R&D team [4][6] - General and administrative expenses also increased to $49.0 million in 2024 from $24.6 million in 2023, driven by personnel-related costs and operational expansion [4][6] Upcoming Milestones - Apogee plans to initiate a Phase 1b trial for APG333 in asthma in the first half of 2025, followed by a Phase 2b trial in the second half of 2025 [3][6] - A Phase 2 trial for APG777 in eosinophilic esophagitis (EoE) is expected to start in 2026 [3][6] - Positive interim data for APG808, another monoclonal antibody targeting IL-4Rα, supports its potential for two- to three-month dosing, with a Phase 1b trial in asthma expected in the first half of 2025 [3][6]

Interim Phase 1 results for APG990, a novel half-life extended OX40L antibody, exceeded trial objectives and demonstrated an approximately 60-day half-life APG279 (APG777 + APG990) Phase 1b head-to-head study vs. DUPIXENT supported by successful completion of preclinical combination toxicology studies and positive APG990 interim Phase 1 results; trial planned to initiate this year with readout expected in second half of 2026 Webcast to be held today at 8:30 a.m. ET SAN FRANCISCO and BOSTON, March 03, 2025 ( ...

Company Overview - Apogee Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing novel biologics for inflammatory and immunology markets, including treatments for atopic dermatitis, asthma, chronic obstructive pulmonary disease, and eosinophilic esophagitis [3] - The company's lead program, APG777, targets atopic dermatitis, which is identified as the largest and least penetrated market in the inflammatory and immunology sector [3] - Apogee aims to achieve best-in-class efficacy and dosing through its antibody programs, which are designed to overcome limitations of existing therapies by utilizing advanced antibody engineering [3] Upcoming Events - Apogee Therapeutics will participate in the TD Cowen 45th Annual Health Care Conference on March 4, 2025, at 2:30 p.m. ET [2] - The company will also be present at the Leerink Global Healthcare Conference on March 11, 2025, at 8:40 a.m. ET [2] - A live and archived webcast of these events will be available on the company's website [2]

Core Insights - Apogee Therapeutics has successfully completed enrollment for Part A of the Phase 2 APEX clinical trial of APG777, exceeding the target with 123 patients enrolled ahead of schedule [1][3] - The first patient has been dosed in Part B of the trial, which focuses on moderate-to-severe atopic dermatitis (AD) [2][3] - APG777 is designed to provide improved dosing and efficacy compared to existing therapies, with a potential reduction in injection frequency [3][4] Company Overview - Apogee Therapeutics is a clinical-stage biotechnology company focused on developing novel biologics for inflammatory and immunology (I&I) markets, including treatments for AD, asthma, and chronic obstructive pulmonary disease (COPD) [2][7] - The company aims to address the limitations of current therapies by utilizing advanced antibody engineering to optimize drug properties [7] Clinical Trial Details - The APEX trial is a Phase 2 randomized, placebo-controlled study evaluating APG777, a monoclonal antibody targeting IL-13, a key cytokine in inflammation [3][4] - Part A of the trial randomized 123 patients in a 2:1 ratio to receive either APG777 or placebo, with a primary endpoint focused on the mean percentage change in EASI score from baseline at week 16 [3][4] - Part B will involve approximately 280 patients randomized to different dosing regimens of APG777 versus placebo [3][4] Future Development Plans - Apogee plans to advance APG777 into additional clinical trials, including a Phase 1b trial in asthma and a Phase 2 trial in eosinophilic esophagitis (EoE) [4][5] - The company is also exploring combination therapies with other investigational drugs to enhance efficacy and safety for I&I conditions [4][5] Product Profile - APG777 is a subcutaneous monoclonal antibody with a half-life of 77 days, demonstrating sustained efficacy in inhibiting IL-13 signaling [5] - The drug is positioned to potentially serve a large patient population, with an estimated 82 million people worldwide suffering from moderate-to-severe AD [5]

Company Overview - Apogee Therapeutics is a clinical-stage biotechnology company focused on developing novel biologics for inflammatory and immune (I&I) markets, including treatments for atopic dermatitis (AD), asthma, chronic obstructive pulmonary disease (COPD), and eosinophilic esophagitis (EoE) [2] - The company's lead program, APG777, targets atopic dermatitis, which is identified as the largest and least penetrated market within the I&I sector [2] - Apogee aims to achieve best-in-class efficacy and dosing through its antibody programs, which are designed to address the limitations of existing therapies by utilizing advanced antibody engineering [2] Upcoming Events - Management of Apogee Therapeutics will participate in a fireside chat at the Guggenheim SMID Cap Biotech Conference on February 5, 2025, at 1:00 p.m. E.T. [1] - A live and archived webcast of the event will be accessible on the company's website [1]

Core Insights - Apogee Therapeutics is advancing its pipeline with promising interim data for APG808 and APG777, indicating potential for innovative dosing regimens and significant market impact in inflammatory and immunology conditions [2][3][5] Group 1: APG808 Developments - APG808 Phase 1 trial results show it was well-tolerated with a half-life of approximately 55 days, suggesting a potential dosing regimen of every 2- to 3-months, significantly longer than current therapies [3][6] - The trial enrolled 32 healthy adult participants, demonstrating deep and sustained effects on pharmacodynamic markers for up to 3 months [3][6] - Apogee plans to evaluate APG808 in a Phase 1b trial for asthma, with data expected in the first half of 2025 [3][6] Group 2: APG777 Progress - APG777 has shown a half-life of 77 days in its Phase 1 trial, supporting a potential annual dosing schedule, which could disrupt the $50 billion atopic dermatitis market [6][5] - The ongoing Phase 2 trial of APG777 in atopic dermatitis is expected to report 16-week topline data in mid-2025, accelerated due to strong enrollment [6][5] - APG777 is also being developed for eosinophilic esophagitis and asthma, with plans for a Phase 1b trial in asthma in the first half of 2025 [6][5] Group 3: Combination Therapies - Apogee is pursuing first-in-class combination therapies, including APG777 with APG990 and APG333, targeting broader inflammatory pathways for enhanced efficacy [7][8][12] - The APG777 + APG990 combination is expected to enter a Phase 1b trial against DUPIXENT in 2025, with results anticipated in the second half of 2026 [9][8] - APG777 + APG333 is planned for a Phase 1 trial by the end of 2024, aiming to address Type 2 and Type 3 inflammation with potentially less frequent dosing [11][12]

Core Insights - Apogee Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing novel biologics for inflammatory and immunology (I&I) markets, including treatments for atopic dermatitis (AD), asthma, and chronic obstructive pulmonary disease (COPD) [1][5] - The company will host a virtual R&D Day on December 2, 2024, to discuss its advancements and future strategies in the I&I space [1] Company Overview - Apogee Therapeutics aims to provide differentiated efficacy and dosing in the I&I markets, targeting conditions such as AD, asthma, and COPD [1][5] - The company’s lead program, APG777, is being developed for AD, which is identified as the largest and least penetrated market in I&I [5] - Apogee's antibody programs are designed to address limitations of existing therapies by targeting established mechanisms of action and utilizing advanced antibody engineering [5] R&D Day Agenda - The agenda includes discussions on Apogee's vision for next-gen biotech, interim results from the APG808 Phase 1 clinical trial, and updates on APG777 [4] - Key opinion leaders will present on topics such as the need for new treatment opportunities in I&I conditions and the potential of IL-13 + OX40L combination therapy for AD [2][4] - The event will also cover commercial opportunities and strategies, concluding with a Q&A session [4] Featured Speakers - Notable speakers include Emma Guttman-Yassky, M.D., Ph.D., and David Singh, M.D., who will provide insights into the current landscape of I&I treatments [2][3]

Core Insights - Apogee Therapeutics, Inc. is hosting a virtual R&D Day on December 2, 2024, to discuss updates on its programs and the potential of its lead candidate APG777 in treating atopic dermatitis [1][2] Company Overview - Apogee Therapeutics is a clinical-stage biotechnology company focused on developing novel biologics for inflammatory and immunology (I&I) markets, including atopic dermatitis, asthma, and chronic obstructive pulmonary disease [1][4] - The company aims to provide differentiated efficacy and dosing through advanced antibody engineering, targeting established mechanisms of action [4] Product Development - APG777 is highlighted as having best-in-class potential for treating atopic dermatitis, which is noted as the largest and least penetrated market within I&I [2][4] - The company is pursuing both monotherapies and combination therapies to achieve superior efficacy and dosing across its portfolio of four validated targets [4] Event Details - The R&D Day will feature presentations from management and guest speakers discussing the current treatment landscape and the need for new therapies in the I&I space [2][3]