Apogee Begins Phase 1 Trial of Extended Half-Life Antibody APG990 for Atopic Dermatitis and Inflammatory Diseases

Apogee Therapeutics, Inc., a clinical-stage biotechnology firm, has recently announced the initiation of dosing healthy volunteers in its first clinical trial for APG990. This novel subcutaneous, half-life extended monoclonal antibody targets OX40L and is aimed initially at treating atopic dermatitis (AD). The firm is known for developing innovative biologics designed to offer differentiated efficacy and dosing for major inflammatory and immunology (I&I) markets, including asthma, chronic obstructive pulmonary disease (COPD), and other related conditions.

Dr. Michael Henderson, Chief Executive Officer of Apogee, emphasized the significance of this development, stating that the early commencement of the APG990 Phase 1 clinical trial is a key milestone in their mission to bring advanced treatments to patients with major I&I diseases. He mentioned that Apogee has successfully advanced three of its programs into clinical trials within a year, demonstrating their commitment to innovation in the field. The company is particularly focused on exploring the efficacy of combining APG990 with APG777, another monoclonal antibody that inhibits IL-13, to potentially offer the best-in-class treatment for AD by employing dual mechanisms of action.

The Phase 1 clinical trial for APG990 is designed as a double-blind, placebo-controlled, first-in-human, single-ascending dose study. It will evaluate the safety, tolerability, and pharmacokinetics (PK) of APG990, enrolling around 40 healthy adults into five cohorts. Apogee expects to have interim data from this trial by 2025. Should the results be positive, the company plans to initiate a Phase 1 clinical trial combining APG777 and APG990 in 2025. This trial will test the combined inhibition of Type 2 inflammation via APG777 and broader inhibition of Type 1-3 inflammation through APG990.

Dr. Carl Dambkowski, Chief Medical Officer of Apogee, highlighted the potential impact of APG990 on the treatment of AD. He pointed out that AD is a complex disease involving multiple inflammatory pathways, and while current treatments target the Type 2 pathway, OX40L offers broader inhibition of all three inflammation pathways (Type 1, Type 2, and Type 3). This could provide more comprehensive treatment options for patients, especially those who do not benefit from existing therapies.

APG990 is distinct from current treatments as it targets OX40L, which is situated upstream in the inflammatory pathway compared to IL-13 or IL-4Rα, potentially influencing a broader range of inflammatory responses. In preclinical studies, APG990 has demonstrated similar or improved potency compared to amlitelimab, with a longer half-life of 26 days versus 21 days for amlitelimab. These studies suggest that APG990 could be administered less frequently, every three to six months, in maintenance phases, representing a significant improvement over first-generation OX40L antibodies which require dosing every four to twelve weeks.

Apogee Therapeutics is dedicated to pushing the boundaries of existing therapies by leveraging advanced antibody engineering to optimize the properties and efficacy of their treatments. The company’s portfolio includes four validated targets, with APG777 being its most advanced program currently under development for AD. Apogee aims to achieve best-in-class efficacy and dosing through both monotherapies and combinations of its novel antibodies, thereby offering significant value and benefits to patients who are underserved by current treatment options.