Apogee Therapeutics Begins Dosing for APG990 in Clinical Trial
Apogee Therapeutics Commences Dosing in Phase 1 Trial of APG990
Interim safety and pharmacokinetic data from Phase 1 healthy volunteers trial anticipated in 2025
Initiation of the first clinical trial of APG777 and APG990 combination expected to commence in 2025 with the potential for greater efficacy in atopic dermatitis and across inflammatory diseases
Apogee Therapeutics, Inc., (NASDAQ: APGE), a biotechnology company advancing unique biologics with the potential for novel efficacy and dosing strategies in the inflammatory and immunology (I&I) sectors, has announced the commencement of healthy volunteer dosing in its initial clinical trial for APG990. This half-life extended monoclonal antibody, administered subcutaneously, is primarily being developed for individuals with atopic dermatitis (AD).
Significant Milestones and Future Plans
“The early initiation of the APG990 Phase 1 clinical trial is a remarkable milestone for Apogee as we remain committed to achieving excellence in our clinical development,” stated Michael Henderson, M.D., Chief Executive Officer of Apogee. “In just one year, we have escalated three programs into clinical trials, significantly advancing potentially innovative treatments for patients impacted by major I&I disorders.” Initially exploring APG990 for AD, the company sees the merit in combining its innovative therapies, APG777 and APG990, leveraging their unique mechanisms for enhanced patient outcomes.
Details of the Clinical Trial
The APG990 Phase 1 clinical trial is a double-blind, placebo-controlled study involving healthy adults, designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of APG990. The trial aims to enroll approximately 40 healthy participants organized into five cohorts, with interim data results anticipated in 2025. Following favorable findings, Apogee plans to initiate a Phase 1 clinical trial combining APG777 and APG990, targeting a first-in-class approach for tackling Type 2 inflammation through targeted interleukin-13 inhibition, along with broader inhibition of inflammation via OX40L.
Advancements in Atopic Dermatitis Treatment
“The ongoing development of the APG990 program marks a pivotal step forward in improving treatment accessibility for patients with atopic dermatitis,” remarked Carl Dambkowski, M.D., Chief Medical Officer of Apogee. AD is characterized by diverse manifestations, where Type 2 inflammation serves as a key driver, along with varied contributions from Type 1 and Type 3 pathways. Current treatments predominantly target Type 2 inflammation, whereas OX40L has the potential for comprehensive inhibition across all three pathways, offering improved treatment alternatives for patients who may not respond effectively to existing therapies.
About APG990
APG990 is an innovative, half-life extended monoclonal antibody designed to target OX40L, initially focused on treating atopic dermatitis. By positioning itself further upstream in the inflammatory process compared to IL-13 or IL-4R?, targeting OX40L may allow for a wider impact on the inflammatory response, potentially addressing Type 1, Type 2, and Type 3 inflammatory pathways. As atopic dermatitis presents differently across various ages, severities, and ethnic backgrounds, APG990 could offer therapeutic options for patients with limited responses to existing treatments. In side-by-side preclinical trials, APG990 has shown comparable or enhanced efficacy to existing medications. Notably, APG990 demonstrated an impressive half-life of 26 days in animal studies, possibly allowing for dosing every three to six months in maintenance scenarios, offering a considerable improvement over first-generation OX40L antibodies requiring more frequent administration.
About Apogee Therapeutics
Apogee Therapeutics specializes in pioneering biologics for improving treatment outcomes within the inflammatory and immunology (I&I) sectors. Focused 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 current treatment limitations by utilizing established biological mechanisms combined with advanced antibody technology for improved pharmacokinetics. With multiple validated targets in its research portfolio, Apogee strives to develop 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 aims to assess the safety, tolerability, and pharmacokinetics of the antibody in healthy volunteers, with a focus on treating 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 provide broader inhibition of inflammation pathways, potentially offering an innovative treatment alternative for patients with atopic dermatitis compared to current therapies.
4. How does Apogee Therapeutics plan to enhance treatment options?
Apogee plans to establish new therapies through its advanced programs like APG990, aiming for better efficacy and easier dosing schedules to improve patient outcomes.
5. Who can be contacted for more information about Apogee?
For investor inquiries, Noel Kurdi can be contacted, and for media-related questions, Dan Budwick is the appropriate contact person.
About Investors Hangout
Investors Hangout is a leading online stock forum for financial discussion and learning, offering a wide range of free tools and resources. It draws in traders of all levels, who exchange market knowledge, investigate trading tactics, and keep an eye on industry developments in real time. Featuring financial articles, stock message boards, quotes, charts, company profiles, and live news updates. Through cooperative learning and a wealth of informational resources, it helps users from novices creating their first portfolios to experts honing their techniques. Join Investors Hangout today: https://investorshangout.com/