Kalaris enrolling phase 1b/2 study of TH103 for nAMD

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Kalaris Therapeutics announced the company is currently enrolling a phase 1b/2 multiple ascending dose (MAD) study of TH103 for the treatment of neovascular age-related macular degeneration (nAMD).¹

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

The company’s phase 1b/2 study replaces a smaller part 2 design originally planned to follow the ongoing phase 1a study.¹ Instead, this study is intended to build upon the company’s phase 1a single ascending dose (SAD) study, with the intention of moving TH103 towards potential phase 3 clinical development.¹

Building on decades of research in anti-VEGF therapy, TH103 is an investigational drug representing a novel approach to treating exudative and neovascular retinal diseases. Kalaris co-founder and current board member, Napoleone Ferrara, MD, who has pioneered work leading to the creation of the anti-VEGF class of drugs, developed TH103.¹

“Having dedicated my career to understanding the role of VEGF in human disease, I am encouraged by the potential of TH103 and its novel molecular approach to potentially provide both increased VEGF inhibition and longer retinal retention,” Ferrara said.¹

“This dose-finding study is a critical step in our efforts to potentially advance this novel investigational therapy toward pivotal trials that could benefit patients with exudative and neovascular retinal diseases.”

Reference:

1. Kalaris Therapeutics, Inc. Kalaris Therapeutics Now Enrolling Phase 1b/2 Multiple Ascending Dose Study of TH103 in Neovascular Age-Related Macular Degeneration. GlobeNewswire News Room. Published September 15, 2025. Accessed September 16, 2025. https://www.globenewswire.com/news-release/2025/09/15/3149933/0/en/Kalaris-Therapeutics-Now-Enrolling-Phase-1b-2-Multiple-Ascending-Dose-Study-of-TH103-in-Neovascular-Age-Related-Macular-Degeneration.html