Linsitinib for thyroid eye disease shows proptosis reduction, safety in phase 2b/3 trial

Key takeaways:

• The trial achieved its primary endpoint of proptosis reduction with linsitinib 150 mg.
• There were no drug-related hearing impairments, significant hyperglycemia or menstrual changes.

Linsitinib, an oral small molecule under development for the treatment of thyroid eye disease, demonstrated proptosis reduction and safety in the phase 2b/3 LIDS trial, according to a press release from Sling Therapeutics.

“In this trial, patients demonstrated a significant improvement in disease with no drug-related hearing impairments, significant hyperglycemia or menstrual changes — a point worth noting as the majority of people living with TED are women,” Raymond Douglas, MD, PhD, chief scientific officer at Sling Therapeutics and professor at Cedars-Sinai Medical Center, told Healio. “It makes sense to start a new patient’s treatment with an oral therapy that shows an early response that increases over time.”

The randomized, double-masked, placebo-controlled study evaluated the safety, pharmacokinetics and efficacy of linsitinib in 90 patients with active moderate to severe thyroid eye disease (TED) who were randomly assigned 1:1:1 to receive linsitinib 150 mg twice a day, linsitinib 75 mg twice a day or placebo for 24 weeks. Linsitinib, which is designed to inhibit the insulin-like growth factor-1 receptor (IGF-1R) target, has an established safety profile in 15 clinical trials in multiple disease areas in more than 900 patients, the release said.

The trial achieved its primary endpoint of proptosis reduction at week 24 with a statistically significant proptosis responder rate of 52% in patients in the 150 mg dose arm. Additionally, linsitinib showed a positive safety profile overall and was well tolerated in areas of interest for the IGF-1R target, including no drug-related hearing impairment or menstrual cycle changes and a 3% rate of hyperglycemia.

Sling Therapeutics is on track to initiate a confirmatory phase 3 trial later this year.

“I believe this therapy will allow a broader number of physicians, including ophthalmologists, to be able to treat patients with TED directly rather than referring them to an oculoplastic surgeon,” Douglas told Healio.

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