Sling Therapeutics, Inc., a biopharmaceutical company, announced the initiation of enrollment in the global Phase 2b LIDS clinical trial for evaluating linsitinib, an oral small molecule insulin-like growth factor I receptor (IGF-1R) inhibitor, in the treatment of active, moderate to severe thyroid eye disease (TED). This trial is significant as linsitinib is the first oral IGF-1R inhibitor to enter late-stage clinical trials for TED, offering a potential reduction in the treatment burden for patients.
TED is a debilitating autoimmune disease affecting approximately 20,000 people annually in the U.S., with a similar prevalence in Europe. It is characterized by dysfunction in the IGF-1R signaling pathway, leading to the growth of excess fibrous tissue behind the eyes, causing inflammation, eye bulging, and double vision. The disease predominantly affects women and is most common in individuals with hyperthyroidism due to Graves’ disease.
The Phase 2b LIDS clinical trial is a randomized, double-mask, placebo-controlled study designed to enroll 75 adult participants across the U.S., Canada, UK, and Europe. Participants must have a clinical diagnosis of Graves’ disease or autoimmune Hashimoto’s thyroiditis associated with active, moderate to severe TED. Linsitinib will be administered orally twice daily for 24 weeks, with the primary endpoint being the percentage of participants who are proptosis responders. Secondary endpoints include changes in proptosis, the Graves’ Ophthalmopathy Quality of Life (GO-QoL) questionnaire overall score, and the percentage of participants who are diplopia responders, CAS categorical responders, and overall responders.
This trial represents a hopeful advancement in providing additional treatment options for TED patients, addressing the need for more convenient drug therapies. For more information about the Phase 2b LIDS clinical trial, visit https://clinicaltrials.gov/ct2/show/NCT05276063.
