Apogee Announces Clinical Trial Advancements in APG777 for AD Treatment

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Apogee Therapeutics presented further positive results from the APG777 phase 1 trial and other studies during its Virtual R&D Day on December 2.¹ APG777 is a novel, subcutaneous monoclonal antibody with an extended half-life, targeting interleukin-13. It enables extended dosing intervals and higher exposure levels in induction.

"APG777 is poised to disrupt the atopic dermatitis (AD) market, with our most recent data suggesting potential dosing as infrequently as once per year -- a revolutionary advancement that has garnered positive feedback from patients, physicians, and payers alike,” Michael Henderson, MD, Chief Executive Officer of Apogee, said in a statement.¹

The initial trial began in August 2023 and interim data was announced in March.² A global phase 2 AD trial began soon after in May. 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 2 multiple-ascending dose cohorts.

Results from the trial showcased a half-life of approximately 77 days with near-complete inhibition of key AD biomarkers for up to 12 months, including sustained pSTAT6 and TARC inhibition. This is consistent with prior safety data and supports the potential of APG777 to be dosed annually. It also supports the improved clinical responses found in the ongoing phase 2 trial.

Single doses up to 1,200 mg and multiple doses of 300 mg were well-tolerated and had mild to moderate treatment-emergent adverse events. The most commonly reported effects were vascular access site pain and headache, but none were severe.

Apogee expects to report topline data from the first part of the phase 2 study in mid-2025. There are also plans to initiate further trials in the development of APG777 for asthma and eosinophilic esophagitis(EoE) treatment in the next 2 years.

“We plan on transforming the standard of care in I&I through three waves of innovation: progressing APG777’s monotherapy program with potential for higher efficacy and transformational dosing in AD, currently in a Phase 2 Part A 16-week trial, with its proof of concept (PoC) readout that has been accelerated to mid-2025 based on strong enrollment; demonstrating APG777’s pipeline-in-a-product monotherapy potential by expanding into EoE as well as asthma; and advancing the first AD combination PoC trial next year with respiratory combo planning underway,” Henderson said in a press release. “Beyond its differentiation as a monotherapy, APG777 combined with APG990 as well as with APG333 presents the opportunity for enhanced efficacy and best-in-class dosing for patients.”¹

APG990, a novel, subcutaneous monoclonal antibody with an extended half-life targeting OX40L, is also being developed for AD. A phase 1 healthy volunteer trial is currently underway to establish its safety and tolerability so it can be used in combination with APG777. This coformulation has shown broad inhibition of Type 1, Type 2, and Type 3 inflammation, retaining stability, injectability, and convenience. Apogee plans to initiate its first combination trial in 2025, evaluating the therapies in approximately 50 to 75 patients with moderate-to-severe AD.

According to the company, “Apogee plans to take a first-in-class combination approach to AD by targeting Types 1-3 inflammation potentially offering JAK-like inhibition without their associated safety concerns. This approach offers the potential for improved clinical responses over monotherapies and best-in-class dosing.”¹

Other positive data was presented at the company’s inaugural R&D Day, highlighting advancements in other inflammatory diseases such as asthma and chronic obstructive pulmonary disease.

References

1. Apogee Therapeutics Highlights Progress and Best-in-Class Potential of Novel Biologic Programs for I&I Diseases at 2024 Inaugural R&D Day. News Release. Apogee Therapeutics. Dec 2, 2024. Accessed Dec 3, 2024. https://investors.apogeetherapeutics.com/news-releases/news-release-details/apogee-therapeutics-highlights-progress-and-best-class-potential

2. 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 Dec3, 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