Apogee Announces Positive Phase 1 Interim Data for APG777 in Atopic Dermatitis, Inflammatory Diseases

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Apogee Therapeutics, Inc. recently announced¹ encouraging interim phase 1 data for APG777, a promising lead product candidate aimed at addressing moderate-to-severe atopic dermatitis (AD) and other inflammatory diseases. The findings have already exceeded the company's trial objectives ahead of the planned schedule, according to Apogee.

APG777 is a novel, subcutaneous monoclonal antibody with an extended half-life, targeting interleukin(IL)-13. It enables extended dosing intervals and higher exposure levels in induction.

The phase 1 trial is a first-in-human, randomized, double-blind, placebo-controlled study. The trial evaluated the safety and pharmacokinetics of APG777 in healthy volunteers, enrolling 40 participants across 3 single-ascending dose and two multiple-ascending dose cohorts.

Results from the trial showcased a half-life of approximately 75 days across doses tested, with deep and sustained inhibition of key AD biomarkers for up to 3 months. Moreover, APG777 demonstrated a favorable safety profile, with single doses up to 1,200mg and multiple doses of 300mg being well-tolerated.

The most common treatment-emergent adverse events (TEAEs) included vascular access site pain and headache, with no Grade 3 TEAEs or severe adverse events (SAEs) observed.

"We are thrilled by the positive PK, PD, and safety findings from our Phase 1 trial," said Michael Henderson, MD, chief executive officer of Apogee, in a news release.¹ "These results underscore the promising potential of APG777 to offer patients a transformational therapy that could drive improved clinical responses and extend dosing intervals."

Jonathan Silverberg, MD, PhD, MPH, professor of dermatology at The George Washington University School of Medicine and Health Sciences, echoed Henderson's sentiments, emphasizing the potential for APG777.

“Currently approved therapies for atopic dermatitis and other immunology indications typically call for injections every two to four weeks, which can lead to poor treatment adherence and long-term disease control,” said Silverberg.¹ “I am very encouraged by the initial data from this study, which demonstrate the potential for APG777 as a well-tolerated treatment with a half-life that would support less frequent injections.”

With significant unmet needs persisting for patients with moderate-to-severe AD, the upcoming phase 2 trial is planned for initiation in the first half of 2024 and aims to evaluate APG777's efficacy in a randomized, placebo-controlled setting.

The phase 2 AD trial, structured as a 16-week study, will enroll approximately 110 patients in part A, focusing on average percentage changes in Eczema Area and Severity Index score from baseline to week 16. Following part A, part B will initiate, encompassing a dose optimization phase with approximately 360 patients randomized to high, medium, or low dose APG777 versus placebo.

Currently, APG777 is also in Apogee's pipeline for asthma, with an anticipated phase 2 trial initiation for that indication in 2025. Apogee also has 3 other half-life extended drugs in its pipeline, including APG808 for chronic obstructive pulmonary disease, APG990 for AD, and APG222 for AD.²

Upon final data for the trials of APG777 in healthy volunteers, Apogee hopes to explore opportunities for research and development of APG777 in additional indications, including alopecia areata, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, eosinophilic esophagitis, and prurigo nodularis.²

References

1. Apogee announces positive interim results from phase 1 healthy volunteer trial for APG777, its novel half-life extended anti-IL-13 antibody for the treatment for atopic dermatitis and other inflammatory diseases, exceeding its trial objectives ahead of Schedule with half-life of approximately 75 days. News release. Apogee Therapeutics. March 5, 2024. Accessed March 6, 2024. https://www.globenewswire.com/news-release/2024/03/05/2840218/0/en/Apogee-Announces-Positive-Interim-Results-from-Phase-1-Healthy-Volunteer-Trial-for-APG777-its-Novel-Half-Life-Extended-Anti-IL-13-Antibody-for-the-Treatment-for-Atopic-Dermatitis-a.html
2. Pipeline: Reshaping the standard of care for inflammatory and immune diseases. Apogee Therapeutics. Accessed March 6, 2024. https://apogeetherapeutics.com/pipeline/