Kalaris Therapeutics Launches Phase 1b/2 Dose-Finding Trial of TH103 for Wet AMD

Kalaris Therapeutics has initiated patient enrollment in a phase 1b/2 multiple ascending dose (MAD) clinical study of TH103, its investigational therapy for wet age-related macular degeneration (AMD). 

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

• Primary Endpoint: Safety and preliminary efficacy at one month after the final injection

• Assessments: Visual acuity, lesion morphology, and other exploratory outcomes

This design replaces a smaller part 2 study originally planned to follow the phase 1a trial, allowing a more comprehensive early look at dose-response relationships and tolerability. Data from the phase 1a SAD study—including safety, preliminary efficacy, and pharmacokinetics—remain on track for release in Q4 2025, with additional details about the phase 1b/2 trial to be shared at that time.

“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.”

TH103 is designed to deliver enhanced VEGF inhibition with extended intraocular durability, aiming to reduce treatment burden while maintaining robust disease control.