Kalaris Therapeutics Now Enrolling Phase 1b/2 Multiple Ascending Dose Study of TH103 in Neovascular Age-Related Macular Degeneration

Core Insights - Kalaris Therapeutics has initiated a Phase 1b/2 multiple ascending dose study for TH103 in patients with neovascular age-related macular degeneration (nAMD) to assess safety and preliminary efficacy [1][2] - The study aims to evaluate multiple dose levels of TH103 in up to 80 nAMD patients, with assessments expected to include safety and preliminary efficacy [1][2] - Initial data from the Phase 1b/2 study is anticipated in the second half of 2026, while data from the ongoing Phase 1a study is expected in Q4 2025 [1][6] Company Overview - Kalaris Therapeutics is a clinical-stage biopharmaceutical company focused on developing treatments for prevalent retinal diseases, particularly those with significant unmet medical needs [8] - The company was founded by Dr. Napoleone Ferrara, who is known for his pioneering research in anti-VEGF therapy [8] - Kalaris is committed to advancing novel therapeutic approaches for conditions such as nAMD, diabetic macular edema (DME), and retinal vein occlusion (RVO) [8] Product Insights - TH103 is a dual-action investigational therapy designed to provide increased and longer-lasting anti-VEGF activity for treating exudative and neovascular retinal diseases [6] - The drug is currently being evaluated in both a Phase 1a single ascending dose study and the newly initiated Phase 1b/2 multiple ascending dose study [6][1] - TH103 represents a novel molecular approach to treatment, building on extensive research in anti-VEGF mechanisms [6][4] Industry Context - Neovascular age-related macular degeneration (nAMD) is a leading cause of vision loss in individuals over 50, affecting millions globally [5] - Despite advancements in anti-VEGF therapies, many patients still experience progressive vision loss, indicating a need for continued innovation in treatment options [5]