Apogee Therapeutics, Inc. (NASDAQ: APGE) has recently announced the initiation of dosing of healthy volunteers in its first clinical trial for APG808, a novel subcutaneous (SQ) extended half-life monoclonal antibody (mAb) targeting IL-4Rα. This antibody is being developed as a treatment for people living with moderate-to-severe chronic obstructive pulmonary disease (COPD), asthma, and other inflammatory and immunology (I&I) diseases.
The company's Chief Executive Officer, Michael Henderson, M.D., stated that this initiation represents another important advancement for Apogee's portfolio of differentiated and optimized biologics. This comes on the heels of the positive interim results from the phase 1 healthy volunteer trial for APG777, the company's second product candidate, which exceeded all of its trial objectives.
APG808 has demonstrated similar binding and femtomolar affinity for IL-4Rα as compared to a first-generation mAb, Dupixent, and has shown similar inhibition to Dupixent across three in vitro assays, measuring downstream functional inhibition of the IL-13/IL-4 pathway. The phase 1 trial for APG808 is designed as a double-blind, placebo-controlled, first-in-human, single-ascending dose trial in healthy volunteers, with interim data expected in the second half of 2024. Pending positive results from the phase 1 trial, the company plans to initiate a potential phase 1b trial in asthma with a data readout in the first half of 2025 and a randomized, placebo-controlled phase 2 clinical trial in patients with moderate-to-severe COPD in 2025.
Apogee aims to overcome limitations of existing therapies for I&I diseases by targeting known biologic drivers of disease and utilizing advanced antibody engineering, such as improved half-life. The company's Chief Medical Officer, Carl Dambkowski, M.D., emphasized the potential benefits of optimizing antibody properties with APG808, which in head-to-head preclinical studies demonstrated similar potency to current therapies but with a significantly longer half-life, potentially leading to less frequent dosing for patients with COPD and significantly improving their quality of life.
APG808 is poised to address the high unmet need in the treatment of COPD, which is estimated to affect approximately 10 percent of the global population 40 years of age and older. The company's positive interim results and the initiation of the APG808 phase 1 healthy volunteer trial reinforce Apogee's commitment to delivering potentially best-in-class biologics designed to significantly improve therapeutic options for patients with I&I diseases. Today the company's shares have moved -4.9% to a price of $65.05. For the full picture, make sure to review Apogee Therapeutics's 8-K report.
