Telios Pharma announces topline results from Phase 2 trial of TL-925 in patients with moderate to severe dry eye disease

(Image Credit: AdobeStock/Alessandro Grandini)

Telios Pharma has announced topline results from its Phase 2 study of TL-925 for individuals with moderate to severe dry eye disease (DED).

TL-925 is a first-in-class, topical Bruton’s tyrosine kinase (BTK) inhibitor that prevents mast cell activation and degranulation, and also blocks the cytokine-driven inflammatory response, and restores lacrimal unit homeostasis, offering the potential for disease modification. According to the company, results showed that it was “well tolerated and the intention-to-treat analysis demonstrated clinically meaningful and statistically significant efficacy relative to vehicle control across multiple signs and symptoms.”¹

The Phase 2 trial, proof-of-concept, multicenter, randomized, double-masked study, evaluated the safety, tolerability, and efficacy of TL-925 versus vehicle control, when dosed twice daily via topical ophthalmic eye drops for 28 days. The vehicle composition was identical to the active formulation except for the exclusion of the active ingredient in TL-925.² In total, 107 subjects with moderate to severe DED were enrolled in the trial.

Based on the results from the Phase 2 trial, a Phase 2b study has been initiated and is currently enrolling patients. In addition to being studied for efficacy in treating DED, TL-925 is also being evaluated in individuals with allergic conjunctivitis.¹

“DED and AC are two of the most common ocular inflammatory disorders and often coexist, presenting unique treatment challenges,” said Gail Torkildsen, MD, a principal investigator in both studies in a press release from Telios. “Positive efficacy results in DED and AC demonstrate that TL-925 can effectively and rapidly halt the cycle of inflammation; these data also validate TL-925’s potential to target the underlying inflammatory mechanisms driving these diseases. It is increasingly apparent that TL-925 may represent a significant leap forward for the effective treatment of DED and AC.”

Complete results for the trial will be revealed at the upcoming Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting 2024 in Seattle, Washington. Results will be shown in a poster titled, “TL-925, a First-in-Class, Topical, Bruton’s Tyrosine Kinase Inhibitor in Subjects with Moderate to Severe Dry Eye Disease.”

References:

1. Telios Pharma Announces Successful Phase 2 Results for TL-925, a Novel Treatment for Dry Eye Disease. Press release; March 6, 2024. Accessed March 7, 2024. https://www.businesswire.com/news/home/20240305038505/en/Telios-Pharma-Announces-Successful-Phase-2-Results-for-TL-925-a-Novel-Treatment-for-Dry-Eye-Disease

2. A Study of TL-925 as a Treatment for Dry Eye Disease. ClinicalTrials.gov. Updated November 18, 2023. Accessed March 7, 2024. https://clinicaltrials.gov/study/NCT05745064