Source – Apogee Therapeutics
Apogee Therapeutics has embarked on a significant milestone by commencing the dosing of healthy volunteers in its inaugural clinical trial for APG777. This lead product candidate, designed as a primary therapy for moderate-to-severe atopic dermatitis (AD) and other inflammatory diseases, signifies a pioneering approach in the field of biologics.
The essence of Apogee’s innovation lies in its strategic targeting of established biologic drivers of disease. Leveraging advanced antibody engineering, the company is engineering product candidates with enhanced attributes, such as extended half-life, to surmount the limitations posed by current therapies for inflammatory and immunology (I&I) diseases.
“The initiation of this Phase I study of APG777 represents an important advancement for Apogee, now a clinical-stage organization, and for our discovery research collaboration with Paragon, a pioneer in developing best-in-class biologics for a range of diseases. By leveraging known targets with differentiated monoclonal antibodies, Apogee has the potential to improve the course of treatment for multiple inflammatory disorders, and APG777 is just the start of our strategy to develop a broad pipeline of potentially best-in-class product candidates. I am proud of the Apogee team’s rapid progress in advancing APG777 to this new stage, ahead of our initial timeline expectations.”
– Michael Henderson, M.D., Chief Executive Officer of Apogee
At the heart of this effort is APG777, a groundbreaking subcutaneous extended half-life monoclonal antibody that homes in on IL-13, a pivotal cytokine in inflammation and a key instigator of AD. Head-to-head preclinical evaluations have demonstrated that APG777 rivals or even surpasses lebrikizumab in inhibiting IL-13 signaling. Notably, APG777 exhibits a significantly prolonged half-life, offering the potential for dosing as infrequently as once every two to three months. AD, a chronic inflammatory skin condition, can exact a toll on patients’ well-being, leading to sleep disruption, psychological distress, heightened infection risk, and persistent discomfort. Current treatments are encumbered by challenges, including demanding injection schedules that can undermine patient adherence.
The Phase I trial for APG777 follows a rigorous design, featuring a double-blind, placebo-controlled format encompassing both single-ascending dose (SAD) and multiple-ascending dose (MAD) segments. Anticipating the participation of approximately 40 healthy adults across three SAD and two MAD cohorts, the primary focus of the trial rests on ensuring safety, with a significant secondary objective being pharmacokinetics (PK). Forecasts indicate the availability of preliminary safety and PK data from this trial by mid-2024. Building upon these findings, Apogee envisions the commencement of a Phase 2 clinical trial in 2024—a randomized, placebo-controlled, 16-week study targeting patients with moderate-to-severe AD.
“Apogee is focused on delivering monoclonal antibody therapeutics with improved half-life and optimized potency, bioavailability, and manufacturability. APG777 is the first realization of these engineering efforts, with highly encouraging preclinical data that demonstrate APG777 has similar potency to current therapies, but with significantly longer half-life that could enable less frequent dosing. A new option providing dosing every two or three months could be a transformative change in the standard of care for moderate-to-severe AD patients.”
– Carl Dambkowski, M.D., Chief Medical Officer of Apogee
Apogee’s pioneering strides in the realm of biologics signal a promising advancement in the pursuit of innovative therapies for inflammatory and immunologic disorders. The initiation of the APG777 Phase I trial underscores the company’s commitment to revolutionizing treatment paradigms, potentially leading to enhanced patient outcomes and an improved quality of life for those grappling with AD and related conditions.
