Tourmaline Bio announces FDA clearance of Investigational New Drug application for TOUR006

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Tourmaline Bio has announced US Food and Drug Administration (FDA) clearance of their Investigational New Drug (IND) application for TOUR006 for the treatment of thyroid eye disease (TED).

According to a press release from the company, 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. 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.¹

Sandeep Kulkarni, MD, Chief Executive Officer of Tourmaline, discussed the IND and planned trial for TOUR006 in the press release.

“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 Kulkarni. “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 8 weeks. Tourmaline plans on 81 participants to be enrolled (27 in each arm) and will be moderate to severe TED patients who are in the active phase of disease. The company stated the primary endpoint for this trial will be proptosis response, or reduction of abnormal eye protrusion, measured at week 20.¹

According to the company TOUR006 has been studied in over 400 autoimmune patients across 6 clinical trials. 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 TOUR006.¹

References:

1. Tourmaline Bio announces FDA clearance of investigational new drug (IND) application for TOUR006, an anti-IL-6 antibody with a differentiated profile for the treatment of thyroid eye disease (TED). Tourmaline. Press Release. August 28, 2023. Accessed August 28, 2023.https://www.tourmalinebio.com/tourmaline-bio-announces-fda-clearance-of-investigational-new-drug-ind-application-for-tour006-an-anti-il-6-antibody-with-a-differentiated-profile-fo