Apogee Therapeutics’ APG777 shows positive Phase 1 results in dermatitis

Apogee Therapeutics announced positive interim Phase 1 data from its first-in-human study of APG777, one of its lead product candidates being developed as a frontline treatment for moderate-to-severe atopic dermatitis, or AD, and other inflammatory diseases. Pharmacokinetic data showed a half-life of approximately 75 days across doses tested and Pharmacodynamic data showed deep and sustained inhibition of key AD biomarkers for ~3 months. 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. These findings represent the potential for improved clinical responses from greater exposures in induction and significantly less frequent dosing in maintenance compared to currently approved biologic therapies. APG777 was well tolerated and showed a favorable safety profile. Based on these data, 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. AD is a chronic inflammatory skin disorder which can lead to sleep disturbance, psychological distress, elevated infection risk and chronic pain, all of which significantly impact quality of life. Apogee plans to advance APG777 into a randomized, placebo-controlled, 16-week Phase 2 clinical trial in patients with moderate-to-severe AD. Phase 2 AD trial is expected to initiate in the 1H of 2024 with 16-week topline data from Part A expected in 2H 2025.