Tourmaline Bio, Inc. (Tourmaline), a late-stage clinical biotechnology company developing transformative medicines to dramatically improve the lives of patients with life-altering immune diseases, today announced U.S. Food and Drug Administration (FDA) clearance of Tourmaline’s IND application for TOUR006.
TOUR006 is a fully-human, anti-IL-6 antibody with differentiated properties including high binding affinity to IL-6 and a naturally long half-life. TED, also known as Graves’ ophthalmopathy, is an autoimmune disease characterized by inflammation and disfigurement around the eye, which can be sight-threatening in severe cases.
Off-label use of IL-6 pathway inhibitors in TED has resulted in reduced inflammation and eye-bulging and has been shown to impact key biomarkers such as levels of pathogenic autoantibodies.
“We are excited to advance TOUR006 into late-stage development in TED. We believe TOUR006 could be an ideal treatment option for patients suffering from TED, in light of its anti-inflammatory mechanism of action, established tolerability profile, attractive dosing schedule, and convenient subcutaneous administration,” said Sandeep Kulkarni, MD, CEO of Tourmaline. “We anticipate top-line data from this trial in the first half of 2025 and expect to further expand the development of TOUR006 into atherosclerotic cardiovascular disease (ASCVD) and other indications. We are also looking forward to the expected closing of our merger with Talaris Therapeutics and listing on Nasdaq in the fourth quarter of 2023.”
The planned Phase 2b trial of TOUR006 in TED is expected to evaluate 20mg and 50mg doses against placebo given by a subcutaneous injection every eight weeks. The approximately 81 participants planned to be enrolled (27 in each arm) will be moderate to severe TED patients who are in the active phase of disease. The primary endpoint for this trial will be proptosis response, or reduction of abnormal eye protrusion, measured at week 20.
About Tourmaline Bio, Inc.
Tourmaline Bio is a late-stage clinical biotechnology company driven by its mission to develop transformative medicines that dramatically improve the lives of patients with life-altering immune diseases.
Tourmaline’s lead program, TOUR006, is an anti-IL-6 antibody that exhibits differentiated properties including high binding affinity to IL-6 and a naturally long half-life. To date, TOUR006 has been studied in over 400 autoimmune patients across six clinical trials.
Tourmaline plans to develop TOUR006 in thyroid eye disease (TED) and atherosclerotic cardiovascular disease (ASCVD) as its first two indications, with additional indications under consideration.
In June 2023, Tourmaline announced it had entered into a definitive agreement with Talaris Therapeutics under which Tourmaline is expected to combine with Talaris. The combined company will operate under Tourmaline’s name and be led by Tourmaline’s current management team, focused on advancing the development of TOUR006.