Telomir Pharmaceuticals said that its lead therapeutic candidate Telomir-1 (Zn-Telomir) demonstrated a favorable safety and tolerability profile in a comprehensive series of IND-enabling Good Laboratory Practice (GLP) toxicology and safety pharmacology studies, supporting continued advancement toward first-in-human clinical development. The company reported that across completed GLP studies—which included cardiovascular, respiratory, phototoxicity and repeated-dose toxicology assessments in both rats and dogs—no treatment-related adverse toxicities or dose-limiting safety concerns were observed with oral administration of Telomir-1. The compound also showed consistent systemic exposure and predictable pharmacokinetic behaviour across studies.
Key findings included no concerning cardiovascular signals such as changes in blood pressure, heart rate or ECG parameters in non-rodent models, minimal and reversible findings in repeated-dose toxicity studies, no significant respiratory effects, and no evidence of phototoxicity under simulated sunlight conditions. Together, these results suggest that Telomir-1’s safety profile is suitable for progression into regulatory submission and human studies, pending applicable approvals.
Telomir said it plans to continue IND-enabling activities and regulatory preparations, with the goal of submitting an Investigational New Drug (IND) application in early 2026 and initiating first-in-human clinical trials in the first half of 2026, subject to regulatory review and acceptance. The company is also conducting ongoing preclinical studies to further characterise Telomir-1’s biological activity across oncology and age-related disease models ahead of clinical development.
