Apogee Therapeutics Reports 9-Month Phase 1 Trial Results for APG777 Anti-IL-13 Antibody

Apogee Therapeutics, Inc., a biotechnology company specializing in the development of novel biologics for inflammatory and immunology (I&I) markets, recently announced positive results from its ongoing Phase 1 clinical trial of APG777. This new anti-IL-13 antibody is being tested for its effectiveness in treating atopic dermatitis (AD) and other inflammatory diseases. The updated data from the trial, which observed healthy volunteers for up to nine months, will be presented at the American College of Allergy, Asthma & Immunology’s (ACAAI) 2024 Annual Scientific Meeting.

The clinical trial included 40 participants across three single-ascending dose (SAD) cohorts, now with nine months of follow-up, and two multiple-ascending dose (MAD) cohorts, with six months of follow-up. The findings revealed that APG777, administered up to 1,200mg in single doses or multiple doses of 300mg, was well-tolerated. Pharmacokinetic data indicated a half-life of approximately 75 days, which is significantly longer than current treatments for moderate-to-severe AD. Additionally, APG777’s pharmacodynamic profile demonstrated near-complete inhibition of pSTAT6 and sustained TARC inhibition for up to nine months.

The results support the ongoing Phase 2 clinical trial of APG777 in patients with moderate-to-severe AD. The drug's potential to improve clinical responses through greater exposures and reduced frequency of maintenance dosing—every three or six months—compared to the current two-to-four week dosing of approved biologic therapies is particularly promising. Apogee plans to release 16-week topline data from Part A of the Phase 2 trial in the second half of 2025.

Dr. Carl Dambkowski, Chief Medical Officer of Apogee, expressed optimism about the Phase 1 trial results, highlighting the potential best-in-class pharmacokinetic and pharmacodynamic profile of APG777. He noted that the drug continues to be well-tolerated and that the maintenance dosing schedule could be significantly less frequent than current treatments for moderate-to-severe AD. The company is on track to present initial data from the Phase 2 trial in the latter half of the upcoming year.

Key findings from the Phase 1 results over nine months include:

1. Dose proportional pharmacokinetics with a half-life of about 75 days, considerably longer than current treatments for moderate-to-severe AD.
2. APG777 exhibited dose proportional increases in Cmax and AUC from doses ranging from 300mg to 1,200mg in both the SAD and MAD cohorts.
3. Both single and multiple doses resulted in rapid and sustained effects on pharmacodynamic markers for up to nine months.
4. Single doses led to rapid and near-complete inhibition of pSTAT6 for up to nine months, while MAD cohorts showed similar inhibition through follow-up.
5. Single doses of APG777 also suppressed TARC, a key inflammatory mediator associated with AD severity, with sustained inhibition observed for up to nine months.
6. APG777 was generally well-tolerated at doses up to 1,200 mg, with treatment-emergent adverse events being mild-to-moderate and unrelated to the drug. There were no serious adverse events or dose-dependent trends observed.

APG777 is a subcutaneous, extended half-life monoclonal antibody targeting IL-13, a critical cytokine in inflammation and a primary driver of AD. Preclinical studies indicated that APG777 demonstrated equivalent or better potency in inhibiting IL-13 signaling compared to lebrikizumab. Its extended half-life suggests that it could offer improved clinical responses with less frequent dosing, enhancing patient compliance.

Apogee Therapeutics is focused on developing novel biologics for the largest I&I markets, including AD, asthma, and chronic obstructive pulmonary disease (COPD). The company’s antibody programs aim to overcome the limitations of existing treatments by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. APG777 is Apogee’s most advanced program, initially developed for AD, which remains one of the largest and least penetrated I&I markets. Seeking to achieve best-in-class efficacy and dosing, Apogee's broad pipeline and expertise aim to deliver significant benefits to patients currently underserved by standard treatments.