Kalaris Therapeutics Reports Positive Initial Phase 1a Data for TH103 in Treatment-Naïve Neovascular AMD

Core Insights - Kalaris Therapeutics announced positive initial data from its Phase 1a trial of TH103, a treatment for neovascular age-related macular degeneration (nAMD), showing significant improvements in vision and retinal anatomy [2][4][5] - TH103 demonstrated a mean improvement of 10 letters in best corrected visual acuity (BCVA) and a 129 μm reduction in central subfield thickness (CST) after one month [6][9] - The drug showed a 27 to 51-fold lower plasma Cmax compared to leading anti-VEGF agents, indicating enhanced intraocular retention and potential for extended treatment durability [3][9][10] Clinical Trial Results - The Phase 1a trial involved 13 treatment-naïve nAMD patients receiving a single intravitreal injection of TH103 at three dose levels (0.5 mg, 1.5 mg, 2.5 mg) [4] - Results indicated robust visual and anatomical improvements, supporting the molecular design of TH103 [5][6] - No dose-limiting toxicities or serious adverse events related to TH103 were observed, with only mild cases of intraocular inflammation noted [7][8] Pharmacokinetics and Treatment Durability - TH103's pharmacokinetic profile aligns with its engineered properties, showing significantly lower systemic exposure and prolonged intraocular residence time [9] - Following a single injection, 31% of patients did not require additional anti-VEGF treatment during the six-month follow-up, suggesting potential for extended durability [10][11] Next Steps in Development - Kalaris is accelerating its clinical development program, continuing enrollment in a Phase 1b/2 multi-ascending dose study to identify optimal dosing for future Phase 3 trials [11] - Preliminary data from the ongoing study is expected in the second half of 2026 [11]