Apogee Therapeutics' Eczema Drug Provides Rapid Itch Relief In Phase 2 Trial

Apogee Therapeutics Inc. (NASDAQ:APGE) stock is experiencing a significant surge, trading almost 29% higher in premarket on Monday.

This substantial increase in stock price follows the release of positive 16-week data from Part A of the Phase 2 APEX clinical trial of APG777, an anti-IL-13 antibody, for moderate-to-severe atopic dermatitis.

Atopic dermatitis, also known as eczema, is a chronic inflammatory skin condition characterized by dry, itchy, and inflamed skin.

Also Read: Apogee Therapeutics’ Investigational Atopic Dermatitis Potential Shows Strong Tolerability, Extended Half-Life in Early Trial

Part A of the trial enrolled 123 adult patients who were randomized 2:1 to APG777 versus placebo and received an induction regimen dosing of 720mg at Weeks 0 and 2, followed by 360mg at Weeks 4 and 12.

Patients benefiting from treatment continued maintenance dosing, evaluating 3- or 6-month dosing of APG777.

The primary endpoint of Part A is the mean percentage change in Eczema Area Severity Index (EASI) score from baseline at Week 16.

Secondary endpoints include EASI-75, EASI-90, Validated Investigator Global Assessment (IGA) 0/1, and Itch Numeric Rating Scale (NRS) at Week 16.

On Monday, the company said the trial met its primary endpoint, with APG777 showing significantly greater least squares mean percent change from baseline at Week 16 with an EASI reduction of 71.0% compared to placebo of 33.8% (p < 0.001).

Highest absolute and placebo-adjusted EASI-75 of any biologic, with 66.9% of participants treated with APG777 achieving EASI-75 compared to 24.6% on placebo.

Pre-specified sensitivity analysis showed consistent results in both moderate and severe patients.

Additionally, an exposure-response relationship was observed, with patients in the two highest quartiles of exposures achieving the highest EASI-75 response at Week 16, 83.3% for quartile three and 89.5% for quartile four.

Additional key secondary endpoints were in line with the standard of care, including vIGA 0/1 (Validated Investigator Global Assessment of clear or almost clear skin) of 34.9% compared to 17.3% for placebo, and EASI-90 (Eczema Area Severity Index, 90% improvement) of 33.9% compared to 14.7% for placebo.

Patients in the highest quartile of exposures achieved the highest response, 63.2% vIGA 0/1 and 63.2% EASI-90 at Week 16. Treatment of patients with APG777 led to a rapid onset of itch relief and achieved a statistically significant reduction by Week 1.

50.7% reduction of Itch NRS from baseline compared to 23.2%. APG777 was well tolerated with a safety profile consistent with other agents in the class.

APEX Part B is a placebo-controlled dose optimization with approximately 280 patients randomized 1:1:1:1 to high, medium, or low dose APG777 versus placebo.

Part B continues to enroll participants, with a readout expected in mid-2026. Data readout from the maintenance phase of APEX Part A, testing 3- and 6-month maintenance dosing, is expected in the first half of 2026.

In other news from Apogee Therapeutics, in May, the company revealed interim data from its Phase 1b trial of APG808 for mild-to-moderate asthma.

The study showed that a multiple-dose regimen of APG808 was well tolerated in asthmatic patients through 12 weeks of available follow-up. The most common treatment-emergent adverse events observed were headache, injection site erythema, and upper respiratory tract infections.

Price Action: APGE stock is trading higher by 28.9% to $61.20 premarket at last check Monday.

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