Published in Pipeline

FDA clears Tourmaline Bio's IND for TED

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2 min read

Tourmaline Bio, Inc. has received FDA clearance for its investigational new drug (IND) application for TOUR006, its product candidate, to treat thyroid eye disease (TED).

Refresh me on the company.

As a late-stage, clinical biotechnology company, Tourmaline is focused on developing therapies for two life-altering immune diseases: TED and atherosclerotic cardiovascular disease (ASCVD). 

Click here for a look at its TOUR006 pipeline.

Talk about TOUR006.

TOUR006 is a fully-human monoclonal antibody with a naturally long half-life and high binding affinity to interleukin-6 (IL-6), a key proinflammatory cytokine that may play a role in the pathogenesis of autoimmune and inflammatory diseases, such as TED and ASCVD.

The antibody is intended to inhibit the IL-6 signaling pathway with relatively low amounts of drug exposure, allowing for a low-volume, infrequently administered, subcutaneous injection delivery, according to Tourmaline.

So how is TOUR006 being tested?

By developing the therapy for indications where IL-6 pathway inhibitors have exhibited promising signs of potential clinical activity, but have not been thoroughly researched (like in TED and ASCVD).

Expand on that, please.

Per Tourmaline, off-label use of IL-6 for TED has resulted in reduced inflammation and proptosis (hallmark signs of the disease), as well as exhibited significant impact on key biomarkers.

See here for research details.

Gotcha. So what comes next?

As part of the IND application clearance by the FDA, Tourmaline plans to initiate a phase 2b clinical trial of TOUR006.

Go on …

The study will assess TOUR006  in two doses—20 mg and 50 mg—versus a placebo via subcutaneous injection every 8 weeks.

An estimated 81 participants are expected to be enrolled (27 patients per arm), each diagnosed with moderate to severe TED.

And what’s being measured?

Per the company, the primary endpoint will be proptosis response, measured at Week 20.

When can we expect data?

Be prepared to wait: Tourmaline anticipates reporting topline data in 2025.

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