Upcoming Milestones for TOUR006 Development in TED and ASCVD

Tourmaline Bio, a clinical-stage biotech firm, is advancing its drug candidate, TOUR006, for the treatment of Thyroid Eye Disease (TED) and Atherosclerotic Cardiovascular Disease (ASCVD). The company intends to initiate a crucial Phase 3 trial for TED in 2024, which will assess the drug's efficacy as a first-line treatment administered subcutaneously every eight weeks. This trial is expected to yield results in 2026, without impacting the company's projected financial runway through the same year.
Additionally, Tourmaline has aligned with the FDA on the clinical development strategy for ASCVD, which includes a Phase 2 trial to begin in the first half of 2024. This trial will investigate the impact of quarterly TOUR006 doses on reducing C-reactive protein levels in patients at high cardiovascular risk, with data anticipated in the first half of 2025.
TOUR006 is a promising, fully-human monoclonal antibody that targets the IL-6 pathway, which is implicated in autoantibody and inflammation-driven diseases. It has demonstrated a naturally long half-life, low potential for immunogenicity, and high binding affinity to IL-6. The drug has been tested in 448 participants across six clinical trials, including those with autoimmune disorders.
Tourmaline's CEO, Dr. Sandeep Kulkarni, highlights the significance of IL-6 in various diseases and the potential of TOUR006 to provide a patient-friendly treatment through its long-acting, low-volume subcutaneous administration. The company's pivotal Phase 3 trial for TED will focus on the drug's ability to reduce abnormal eye protrusion, with additional measures including clinical activity score, double vision, and quality of life.
For ASCVD, TOUR006 is being developed with a quarterly dosing regimen, which differs from other IL-6 inhibitors that require more frequent administration. The Phase 2 trial will involve 120 patients and assess changes in high-sensitivity C-reactive protein levels as the primary endpoint. Dr. Yung Chyung, Tourmaline's CMO, believes that TOUR006 could address the significant unmet medical need in ASCVD management by targeting the IL-6 pathway and offering a convenient dosing schedule.
Tourmaline is committed to developing transformative medicines for patients with severe immune and inflammatory diseases. The company's financial outlook remains robust, with sufficient resources projected to last through 2026, covering key data readouts for TOUR006 in both TED and cardiovascular disease.