Apogee Therapeutics, Inc. (NASDAQ: APGE) has announced the initiation of the dosing of healthy volunteers in its clinical trial of APG333, a novel, subcutaneous (SQ) half-life extended monoclonal antibody targeting thymic stromal lymphopoietin (TSLP). This antibody is being evaluated initially as a treatment for people living with asthma, chronic obstructive pulmonary disease (COPD), and broader inflammatory and immunology (I&I) conditions.
The phase 1 clinical trial of APG333 is designed as a double-blind, placebo-controlled, first-in-human, single-ascending dose trial in healthy volunteers. It is expected to enroll approximately 32 healthy adults into 4 cohorts and will evaluate the safety, tolerability, and pharmacokinetics (PK) of APG333. Apogee anticipates interim data from the trial in the second half of 2025.
In preclinical studies, the combination of APG777 + APG333 has been shown to drive broader and deeper inhibition of inflammation centrally with deeper impact on local airway responses compared to approved or in-development biologics, with the potential for a significantly less frequent dosing schedule.
APG333 is a novel, SQ extended half-life monoclonal antibody targeting TSLP, a key driver of type 2 and type 3 inflammation in eosinophilic and non-eosinophilic conditions. TSLP is an epithelial cell-derived cytokine that has emerged as an attractive validated target for the treatment of I&I indications. A TSLP-targeting monoclonal antibody may be used in combination with other monoclonal antibodies for potentially greater efficacy in broader populations. TSLP inhibition has been clinically validated, with one approved product on the market for the treatment of severe asthma without biomarker or phenotype restrictions.
Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, including for the treatment of atopic dermatitis (AD), asthma, COPD, eosinophilic esophagitis (EOE), and other I&I indications. Apogee's antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. APG777, the company’s most advanced program, is being initially developed for the treatment of AD, which is the largest and one of the least penetrated I&I markets. The market has reacted to these announcements by moving the company's shares -1.2% to a price of $48.47. For more information, read the company's full 8-K submission here.
