Telios Pharma Announces Successful Phase 2 Results for TL-925, a Novel Treatment for Dry Eye Disease

Telios Pharma, Inc., a clinical stage biopharmaceutical company committed to improving the lives of patients with inflammatory diseases, today announced topline results from its Phase 2 study assessing TL-925, a first-in-class topical Bruton's tyrosine kinase (BTK) inhibitor for individuals with moderate to severe dry eye disease (DED). This proof-of-concept, multicenter, randomized, double-masked study evaluated the safety, tolerability, and efficacy of TL-925 versus vehicle control, when dosed twice daily for 28 days.

A total of 107 subjects with moderate to severe DED were enrolled. TL-925 was safe and well tolerated and the intention-to-treat analysis demonstrated clinically meaningful and statistically significant efficacy relative to vehicle control across multiple signs and symptoms. The rapid onset of efficacy across multiple ocular regions, coupled with favorable and consistent results in different environments confirm TL-925's differentiated profile as a safe, well-tolerated, and effective treatment for patients with DED.

Complete results will be presented at the upcoming Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting 2024, to be held from May 5-9, 2024, in Seattle, Washington.

Poster: 2965 - A0124
Title: TL-925, a First-in-Class, Topical, Bruton's Tyrosine Kinase Inhibitor in Subjects with Moderate to Severe Dry Eye Disease
Session: 316
Date & Time: May 7, 2024, 08:30 - 10:15

"We are thrilled by these findings and honored to have been selected to share our groundbreaking research with the ophthalmology community at ARVO," said Jesse McGreivy, CEO of Telios Pharma. "Our team is excited about advancing TL-925 through the next stages of clinical development with the aim of further demonstrating its ability to address the underlying cause of dry eye disease, an underdiagnosed and often poorly managed condition that affects many millions of people worldwide."

"I am highly encouraged by the breadth of positive results from this Phase 2 study and hopeful about the potential for TL-925 to impact the underlying pathology of DED," said George Ousler, lead investigator and Senior Vice President at Ora Inc., the world's leading full-service ophthalmic research organization, which oversaw the trial. "The results are among the most impressive that I have seen in my years working on dry eye clinical development programs. TL-925 is a promising and much needed novel approach for the treatment of DED."

A Phase 2b study of TL-925 in DED has been initiated based on these results and is currently enrolling patients. Consistent with TL-925's efficacy in DED, a separate Phase 2 study evaluating the safety and efficacy of TL-925 in individuals with allergic conjunctivitis (AC) has recently shown clinically meaningful and statistically significant improvements in both itching and redness. These data will be presented at a medical congress later this year.

"DED and AC are two of the most common ocular inflammatory disorders and often coexist, presenting unique treatment challenges," said Gail Torkildsen, MD, a board-certified ophthalmologist at Andover Eye Associates and principal investigator in both studies. "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."

About Telios Pharma, Inc.

Telios Pharma is a privately held clinical stage biopharmaceutical company with a first-in-class topical and oral BTK program targeting mast cell-mediated inflammation and allergy.

About TL-925

Dry eye disease, a chronic inflammatory disorder of the lacrimal unit, causes ocular discomfort, pain, and visual disturbances. Mast cells, found in the lacrimal functional unit, are key initiators and amplifiers of the inflammatory cascade. TL-925, an ophthalmic formulation of the potent, irreversible BTK inhibitor TL-895 prevents mast cell activation and degranulation, blocks the cytokine-driven inflammatory response, and restores lacrimal unit homeostasis, offering the potential for disease modification. Our novel approach to treating DED targets BTK, which has been shown to be critical for mast cell activation and immune response.