Sling Therapeutics has announced positive data from clinical trials of a potential new treatment option for moderate to severe thyroid eye disease (TED).
Linsitinib, Sling’s lead product candidate, is an oral small molecule, taken twice daily, in clinical development for TED. It works by inhibiting the validated IGF-1R target and has an established safety profile through treatment of more than 900 patients across 15 clinical trials in multiple disease areas.
Dr Ryan Zeidan, Sling’s President and Chief Executive Officer, said the data establish linsitinib’s clinical significance and “represent the first ever successful clinical trial of an oral small molecule for the treatment of TED”.1
“We believe linsitinib can be a potential new treatment option that could enable a broader number of physicians across multiple therapeutic disciplines to treat patients diagnosed with TED.”
The LIDS Phase 2b/3, randomised, double-masked, placebo-controlled study was designed to evaluate the safety, pharmacokinetics, and efficacy of linsitinib in patients with active, moderate to severe TED.
Ninety patients were randomised 1:1:1 and received either linsitinib 150 mg twice a day, linsitinib 75 mg twice a day, or placebo for 24 weeks. The primary endpoint of the study – the percentage of subjects who were proptosis responders at week 24, defined as at least a 2 mm reduction in proptosis from baseline – was met with statistical significance for the 150 mg dose. Importantly, the trial demonstrated a favourable safety profile on key adverse events of interest.
A Phase 3 registrational trial is planned for later this year.
We believe linsitinib can be a potential new treatment option that could enable a broader number of physicians across multiple therapeutic disciplines to treat patients diagnosed with TED
Reference
- Sling Therapeutics, Sling Therapeutics announces positive topline results from Phase 2b/3 LIDS clinical trial of oral small molecule linsitinib in patients with thyroid eye disease (media release, 14 Jan 2025) available at: prnewswire.com/news-releases/sling-therapeutics-announces-positive-topline-results-from-phase-2b3-lids-clinical-trial-of-oral-small-molecule-linsitinib-in-patients-with-thyroid-eye-disease-302350327.html [accessed Jan 2025].
