Apogee Therapeutics Inc ( APGE ) released interim Phase 1 data of APG777, one of its lead product candidates, being developed as a frontline treatment for moderate-to-severe atopic dermatitis (AD) and other inflammatory diseases. 

Pharmacokinetic (PK) data showed a half-life of approximately 75 days across doses tested, and Pharmacodynamic (PD) data showed deep and sustained inhibition of key AD biomarkers pSTAT6 and TARC for ~3 months (longest follow-up available, with inhibition still ongoing at the time of the data cut).

Results from the trial exceeded the company’s trial objectives and support the potential for APG777 to optimize exposure levels in 16-week induction and be dosed once every three or six months in maintenance. 

Single doses of APG777 up to 1,200mg and multiple doses of 300 mg were well tolerated with a favorable safety profile.

The company plans to initiate a randomized, placebo-controlled, Phase 2 clinical trial in patients with moderate-to-severe AD in the first half of 2024 ahead of schedule. 16-week topline data from Part A is expected in 2H 2025.

Part A is expected to enroll approximately 110 patients randomized 2:1 to APG777 vs placebo with a primary endpoint of mean percentage changes in EASI score from baseline to Week 16.

 Part B of the Phase 2 trial is a randomized, placebo-controlled dose optimization with approximately 360 patients randomized 1:1:1:1 to high, medium, or low dose APG777 vs. placebo with a primary endpoint of mean percentage changes in EASI score from baseline to Week 16

 All patients benefiting from treatment will continue to APG777 maintenance, which will evaluate 3- to 6-month dosing.

 The induction regimen is designed to exceed lebrikizumab exposures by ~30-40% and every 3- or 6-month maintenance dosing.

 Apogee also plans to evaluate APG777 in expansion indications, including initiating a Phase 2 trial in asthma in 2025.

“2023 was a momentous year for Apogee with the completion of a successful IPO, initiation of our first clinical program of APG777 in healthy volunteers, and the nomination of our second pipeline candidate, APG808,” said Michael Henderson, CEO of Apogee. 

The company said the cash position of $395.5 million is expected to fund its operating expenses into the fourth quarter of 2026.

Price Action: APGE shares are up 48.70% at $62.01 on the last check Tuesday.