Kalaris Begins Phase 1b/2 Trial of TH103 for Wet AMD

Kalaris Therapeutics has initiated a Phase 1b/2 multiple ascending dose (MAD) clinical trial to evaluate TH103, its investigational therapy for wet age-related macular degeneration (AMD). This study marks a key milestone in the company’s clinical development program for the treatment of neovascular AMD (nAMD).

Study Design and Objectives

The Phase 1b/2 trial will assess multiple dose levels of TH103 in up to 80 patients with wet AMD. Participants will receive up to four monthly intravitreal injections, followed by an extension phase for ongoing evaluation.

Primary Endpoint:

• Safety and preliminary efficacy assessed at one month after the final injection

Key Assessments:

• Visual acuity

• Lesion morphology

• Additional exploratory outcomes

This updated study design replaces a smaller Part 2 trial originally planned to follow the Phase 1a study. The new approach enables a more comprehensive early assessment of dose-response relationships and tolerability.

TH103: Aiming to Improve Treatment Durability in Wet AMD

TH103 is engineered to deliver enhanced VEGF inhibition with extended intraocular durability, with the goal of reducing treatment burden while maintaining effective disease control in patients with wet AMD.

“The phase 1b/2 study represents an important milestone in advancing TH103 toward a potential future phase 3 program,” said Andrew Oxtoby, Chief Executive Officer of Kalaris Therapeutics.

“We remain committed to developing this innovative therapy with the goal of potentially addressing major unmet needs in the treatment of retinal diseases such as nAMD.”

Timeline and Next Steps

Data from the completed Phase 1a single ascending dose (SAD) study, which includes safety, preliminary efficacy, and pharmacokinetics, are expected in Q4 2025. Additional details regarding the ongoing Phase 1b/2 study will also be shared at that time.