Apogee Therapeutics Begins Dosing in Phase 1 Trial of APG990
Interim safety and pharmacokinetic data from the Phase 1 trial involving healthy volunteers is expected in 2025.
The first clinical trial combining APG777 and APG990 is anticipated to start in 2025, aiming for improved efficacy in treating atopic dermatitis and other inflammatory diseases.
Apogee Therapeutics, Inc. (NASDAQ: APGE), a biotechnology firm focused on developing innovative biologics with the potential for groundbreaking efficacy and dosing strategies in the inflammatory and immunology (I&I) sectors, has announced that it has begun dosing healthy volunteers in its initial clinical trial for APG990. This monoclonal antibody, designed for extended half-life and administered subcutaneously, is primarily being developed for individuals suffering from atopic dermatitis (AD).
Key Milestones and Future Directions
“The early launch of the APG990 Phase 1 clinical trial is a significant milestone for Apogee as we remain dedicated to excellence in our clinical development,” said Michael Henderson, M.D., Chief Executive Officer of Apogee. “In just one year, we have advanced three programs into clinical trials, making substantial progress toward innovative treatments for patients affected by major I&I disorders.” Initially focusing on APG990 for AD, the company recognizes the potential of combining its therapies, APG777 and APG990, to leverage their unique mechanisms for improved patient outcomes.
Clinical Trial Overview
The APG990 Phase 1 clinical trial is a double-blind, placebo-controlled study that involves healthy adults. It aims to evaluate the safety, tolerability, and pharmacokinetics (PK) of APG990. Approximately 40 healthy participants will be enrolled, organized into five cohorts, with interim data results expected in 2025. If the findings are favorable, Apogee plans to initiate a Phase 1 clinical trial that combines APG777 and APG990, targeting a pioneering approach to combat Type 2 inflammation through targeted interleukin-13 inhibition, along with broader inflammation inhibition via OX40L.
Progress in Atopic Dermatitis Treatment
“The ongoing development of the APG990 program represents a crucial advancement in enhancing treatment accessibility for patients with atopic dermatitis,” noted Carl Dambkowski, M.D., Chief Medical Officer of Apogee. AD is characterized by a range of symptoms, with Type 2 inflammation being a primary driver, alongside contributions from Type 1 and Type 3 pathways. Current treatments mainly target Type 2 inflammation, whereas OX40L has the potential to inhibit all three pathways comprehensively, providing improved treatment options for patients who may not respond well to existing therapies.
About APG990
APG990 is a cutting-edge, half-life extended monoclonal antibody that targets OX40L, initially aimed at treating atopic dermatitis. By acting further upstream in the inflammatory process compared to IL-13 or IL-4R?, targeting OX40L could have a broader impact on the inflammatory response, potentially addressing Type 1, Type 2, and Type 3 inflammatory pathways. Given that atopic dermatitis manifests differently across ages, severities, and ethnic backgrounds, APG990 may provide therapeutic options for patients who have limited responses to current treatments. In comparative preclinical trials, APG990 has shown similar or enhanced efficacy compared to existing medications. Notably, APG990 exhibited an impressive half-life of 26 days in animal studies, which could allow for dosing every three to six months during maintenance, representing a significant improvement over first-generation OX40L antibodies that require more frequent administration.
About Apogee Therapeutics
Apogee Therapeutics is dedicated to pioneering biologics that enhance treatment outcomes in the inflammatory and immunology (I&I) sectors. Concentrating on conditions such as atopic dermatitis (AD), asthma, chronic obstructive pulmonary disease (COPD), and other inflammatory diseases, Apogee's antibody programs aim to address and overcome existing treatment limitations by utilizing established biological mechanisms combined with advanced antibody technology for improved pharmacokinetics. With multiple validated targets in its research portfolio, Apogee is committed to developing best-in-class treatment solutions through both standalone therapies and innovative combinations.
Contact Information
Investor Contact:
Noel Kurdi
VP, Investor Relations
Apogee Therapeutics, Inc.
Noel.Kurdi@apogeetherapeutics.com
Media Contact:
Dan Budwick
1AB Media
dan@1abmedia.com
Frequently Asked Questions
1. What is the primary focus of the APG990 clinical trial?
The APG990 clinical trial is designed to evaluate the safety, tolerability, and pharmacokinetics of the antibody in healthy volunteers, specifically targeting atopic dermatitis.
2. When are results from the clinical trial expected?
Interim results from the APG990 Phase 1 clinical trial are anticipated in 2025 as the study progresses with healthy participants.
3. What is the significance of targeting OX40L in treating atopic dermatitis?
Targeting OX40L may allow for broader inhibition of inflammation pathways, potentially providing an innovative treatment alternative for patients with atopic dermatitis compared to existing therapies.
4. How does Apogee Therapeutics plan to enhance treatment options?
Apogee aims to develop new therapies through advanced programs like APG990, focusing on better efficacy and simplified dosing schedules to improve patient outcomes.
5. Who can be contacted for more information about Apogee?
For investor inquiries, you can reach out to Noel Kurdi, while Dan Budwick is the contact person for media-related questions.
