Sling Therapeutics announces topline efficacy and safety data from Phase 2b/3 LIDS trial on linsitinib

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Late-stage biopharmaceutical company Sling Therapeutics has announced topline efficacy and safety data from the Phase 2b/3 LIDS trial on linsitinib in patients with active, moderate to severe thyroid eye disease (TED).¹ Linsitinib, which is Sling’s lead product candidate, is an oral small molecule that works by inhibiting the validated IGF-1R target when taken twice daily, according to a news release.

“The positive data from this trial establish the clinical significance of linsitinib and represent the first ever successful clinical trial of an oral small molecule for the treatment of TED,” said Ryan Zeidan, PhD, president and CEO of Sling Therapeutics, in the release. “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. We are excited to continue our clinical program and are on track to initiate our confirmatory Phase 3 registrational trial later this year.”

The Phase 2b/3, randomized, double-masked, placebo-controlled study was designed to evaluate the safety, pharmacokinetics, and efficacy of linsitinib, and had a primary endpoint of the percentage of subjects who were proptosis responders at week 24, defined as at least a 2 mm reduction in proptosis from baseline. This particular trial enrolled 90 patients randomized 1:1:1, who received either linsitinib 150mg BID, linsitinib 75mg BID, or placebo for the full 24 weeks. The global trial was conducted in 35 sites in 5 countries. Additionally, linsitinib has previously been involved more than 900 patients in 15 clinical trials in multiple trials in multiple disease areas. Through said trials, linsitinib was found to have an established safety profile.¹

The trial met its primary endpoint with statistical significance for the 150mg BID dose, with a proptosis responder rate of 52% (p=0.01). Llinsitinib also validated the safety profile seen in previous oncology studies, as well as demonstrated a favorable safety profile on key adverse events of interest for the IGF-1R target. These events include hearing impairment, hyperglycemia, and menstrual cycle changes. No QTc prolongation was observed in any patient that participated in rigorous ECG monitoring in the study.¹

“TED is a debilitating auto-immune disorder with limited options available for patients today. Patients must currently choose between an invasive orbital surgery or eight infusions over 24 weeks, which can be inconvenient and time-consuming and pose serious potential risks,” said Raymond Douglas, MD, PhD, Professor at Cedars-Sinai Medical Center and KOL and lead investigator in previous TED trials, as well as Chief Scientific Officer at Sling Therapeutics, in the release. “In this trial, patients demonstrated significant improvement in disease with no drug-related hearing impairments or significant hyperglycemia. These side effects are the largest barriers for current medical treatments, making linsitinib an important potential new therapy for patients with TED. As a practicing physician, it makes sense to start a new patient’s treatment journey with an oral therapy that shows an early response that increases over time.”

Sling will be engaging with regulatory authorities to discuss its confirmatory Phase 3 trial design, on track to begin in 2025. Full results from the Phase 2b/3 trial are also forthcoming.¹

Reference

1. Sling Therapeutics announces positive topline results from Phase 2b/3 LIDS clinical trial of oral small molecule linsitinib in patients with thyroid eye disease. News release. Sling Therapeutics. January 14, 2025. Accessed January 17, 2025. https://www.slingtx.com/2025/01/14/sling-therapeutics-announces-positive-topline-results-from-phase-2b-3-lids-clinical-trial-of-oral-small-molecule-linsitinib-in-patients-with-thyroid-eye-disease/