Apogee Therapeutics (NASDAQ: APGE) Announces Positive Results up to 9 Months from Phase 1 Trial of APG777 for Atopic Dermatitis and Inflammatory Diseases

Apogee Therapeutics, a clinical-stage biotechnology company, recently disclosed updated positive results from its ongoing Phase 1 clinical trial of APG777, a novel anti-IL-13 antibody designed for the treatment of inflammatory diseases, including atopic dermatitis. The findings, announced on October 24, 2024, showcased encouraging outcomes up to nine months post single and multiple doses of APG777.

The pharmacokinetic data revealed a half-life of approximately 75 days, demonstrating a potentially best-in-class profile compared to existing treatments for moderate-to-severe atopic dermatitis. Notable findings included near complete inhibition of pSTAT6 and sustained TARC inhibition, enhancing the prospects of improved clinical responses through extended dosing intervals of every three to six months.

The ongoing Phase 2 clinical trial of APG777 in patients with moderate-to-severe atopic dermatitis aims to incorporate these positive results. Apogee anticipates the presentation of proof-of-concept data in the second half of 2025, further shedding light on the efficacy and dosing regimen of the drug.

Carl Dambkowski, M.D., Chief Medical Officer of Apogee, remarked on the Phase 1 trial’s outcomes, emphasizing the potential for a best-in-class profile for APG777. He highlighted the sustained inhibition observed in critical biomarkers, the well-tolerated safety profile, and the optimism for achieving maintenance dosing with extended intervals.

The data presented at the American College of Allergy, Asthma, and Immunology’s 2024 Annual Scientific Meeting accentuated APG777’s efficacy and safety profile. These results build upon previous positive interim data, affirming the drug’s promising attributes in addressing atopic dermatitis and other inflammatory conditions.

Apogee’s strategic collaboration with Paragon Therapeutics paved the way for the development of APG777, offering a novel therapeutic avenue for patients facing challenges with existing treatments. The company’s commitment to advancing biologics with enhanced efficacy and dosing regimens underscores its dedication to addressing unmet medical needs in inflammatory and immunology markets.

Investors and stakeholders can anticipate further updates on APG777’s progress and the company’s broader pipeline during Apogee’s R&D Day scheduled for December 2nd. The innovative advancements in drug development and potential market impact signify a pivotal moment for Apogee Therapeutics in redefining treatment paradigms for inflammatory diseases.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Apogee Therapeutics’s 8K filing here.

About Apogee Therapeutics

Apogee Therapeutics, Inc, through its subsidiary, operates as a biotechnology company that develops biologics for the treatment of atopic dermatitis (AD), asthma, chronic obstructive pulmonary disease (COPD), and related inflammatory and immunology indications. The company primarily develops APG777, a subcutaneous (SQ) extended half-life monoclonal antibody (mAb) for AD; and APG808, an SQ extended half-life mAb for COPD.