**Apogee Therapeutics Announces Progress in APEX Clinical Trial for APG777 in Atopic Dermatitis Treatment**

On February 3, 2025, Apogee Therapeutics, Inc. (NASDAQ: APGE) revealed that significant milestones had been achieved in the Phase 2 APEX clinical trial involving APG777 for patients with moderate-to-severe atopic dermatitis (AD). The company disclosed the dosing of the first patient in the Part B segment of the trial and the successful completion of enrollment in the Part A phase.

The Phase 2 APEX trial focuses on APG777, a novel subcutaneous extended half-life monoclonal antibody targeting IL-13, a key cytokine in inflammation crucial for AD progression. This trial innovatively combines the usual Phase 2a and 2b segments into a single protocol, with Part A exceeding anticipated enrollment by randomizing 123 patients to APG777 or a placebo. Part B will now proceed with approximately 280 patients randomized to different doses of APG777 and a placebo.

The primary goal of both trial sections revolves around the mean percentage change in the Eczema Area and Severity Index (EASI) score from baseline at week 16, with secondary objectives assessing the EASI-75 and the Investigator’s Global Assessment at the same time point. Patients who respond well to treatment will continue onto APG777 maintenance dosing for evaluation under 3- or 6-month regimens, with data from each section expected at different intervals between 2025 and 2026.

However, Apogee underlined the prudent nature of the disclosed information, emphasizing that the statements could be considered forward-looking and subject to a range of uncertainties and risks beyond the company’s control. Specific risks include global economic conditions, the progression and outcomes of clinical trials, regulatory timelines, and capital resources.

APGE’s Chief Medical Officer, Carl Dambkowski, M.D., praised the trial’s progress and the potential of APG777 to offer improved treatment options with reduced injection burden for AD and other inflammatory conditions. He highlighted that the unique trial design enabled the swift transition between the trial’s phases, streamlining developments and potentially accelerating the drug’s availability to patients.

In conclusion, Apogee’s advancements in the Phase 2 APEX trial mark a significant step forward in their pursuit of delivering innovative therapies for inflammatory and immunology conditions like atopic dermatitis.

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.