Apogee Therapeutics, Inc. (NASDAQ: APGE), a clinical-stage biotechnology company, has announced the initiation of dosing of healthy volunteers in its first clinical trial for APG990, a novel, subcutaneous (SQ) half-life extended monoclonal antibody targeting ox40l, initially being developed for the treatment of atopic dermatitis (AD). The company also disclosed that it has advanced three of its programs into clinical trials in just 12 months.
The APG990 phase 1 clinical trial is designed as a double-blind, placebo-controlled, first-in-human, single-ascending dose trial in healthy volunteers, expected to enroll approximately 40 healthy adults into 5 cohorts. Apogee expects interim data from the trial in 2025. Pending positive results from the phase 1 clinical trial and following submission of an investigational new drug application or foreign equivalent, the company plans to initiate a phase 1 clinical trial of APG777 and APG990 as a potential first-in-class approach to test the combination.
The company's Chief Executive Officer, Michael Henderson, M.D., stated, “We have advanced three of our programs into clinical trials in just 12 months, bringing potentially differentiated treatments closer to patients living with the largest inflammatory and immunology (I&I) diseases. We are initially exploring APG990 for AD, and we believe combining two of the most active, orthogonal mechanisms of IL-13 (APG777) with ox40l (APG990) has the potential to expand patient reach with best-in-class efficacy and dosing."
Carl Dambkowski, M.D., Chief Medical Officer of Apogee, added, “While currently available treatments are targeted at the type 2 pathway, ox40l has been clinically validated to provide broad inhibition of all three inflammation pathways and could enhance treatment options for patients. We plan to investigate APG777 and APG990, our extended half-life mabs, which could provide both deeper and broader responses, delivering the potential for better overall outcomes and best-in-class dosing for patients living with AD and other I&I diseases.”
Furthermore, in head-to-head preclinical assays, APG990 has demonstrated similar or improved potency to amlitelimab. In head-to-head studies of APG990 and amlitelimab in non-human primates, APG990 demonstrated a half-life of 26 days versus 21 days for amlitelimab. If successful in clinical trials, APG990 could be dosed every three to six months in maintenance, representing a significant improvement compared to first-generation ox40l antibodies that are expected to be dosed every four to twelve weeks.
Apogee Therapeutics is 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), and other I&I indications.
The company's progress in bringing potentially differentiated treatments closer to patients and its focus on combining active, orthogonal mechanisms to expand patient reach with best-in-class efficacy and dosing demonstrate its commitment to innovation in treating patients with AD and other I&I diseases. The market has reacted to these announcements by moving the company's shares -0.1% to a price of $45.25. For the full picture, make sure to review Apogee Therapeutics's 8-K report.
