Sling Therapeutics Reports Positive Phase 2b/3 LIDS Trial Results for Linsitinib in Thyroid Eye Disease

Sling Therapeutics, Inc., a biopharmaceutical company based in Ann Arbor, Michigan, has announced encouraging results from its Phase 2b/3 clinical trial of linsitinib, a novel treatment for Thyroid Eye Disease (TED). This condition is a rare and serious autoimmune disorder that can lead to significant eye problems, including inflammation and proptosis—an abnormal protrusion of the eye. The trial's findings suggest that linsitinib, administered orally, offers a promising new approach for managing TED, potentially increasing treatment options for patients and healthcare providers.

Linsitinib is a twice-daily oral medication that specifically targets the insulin-like growth factor-1 receptor (IGF-1R), a critical player in the pathological process of TED. By inhibiting this receptor, linsitinib aims to reduce the inflammation and tissue growth responsible for the eye symptoms associated with the disease. This trial marks the first successful clinical demonstration of an oral small molecule therapy that has shown statistical and clinical significance in reducing TED symptoms.

The recently completed Phase 2b/3 LIDS trial was a randomized, double-masked, placebo-controlled study involving 90 patients with active moderate to severe TED. The primary goal was to assess the percentage of patients who showed a significant reduction in proptosis, defined as a decrease of at least two millimeters from baseline, after 24 weeks of treatment. Participants were divided into three groups, receiving either linsitinib at doses of 150mg or 75mg, or a placebo.

Results showed that the 150mg dose of linsitinib achieved the primary endpoint, with a statistically significant reduction in proptosis observed in 52% of patients at the 24-week mark. Importantly, the medication was well-tolerated, with no significant adverse events related to hearing impairment, hyperglycemia, or menstrual cycle changes, which are common concerns with current therapies. The trial also confirmed the safety profile of linsitinib, with the majority of adverse events being mild or moderate and resolving quickly upon treatment discontinuation.

Raymond Douglas, M.D., Ph.D., a professor at Cedars-Sinai Medical Center and the chief scientific officer at Sling Therapeutics, highlighted the importance of these findings. He noted that current TED treatments often require invasive surgery or lengthy infusion procedures, leading to significant inconvenience and risk for patients. The success of linsitinib in reducing proptosis without severe side effects presents a potentially transformative option for those affected by TED.

Sling Therapeutics plans to engage with regulatory bodies to discuss the design of a confirmatory Phase 3 trial, which is scheduled to begin in 2025. The company aims to present the full results of the Phase 2b/3 trial at an upcoming medical conference, further detailing linsitinib's efficacy and safety profile.

This development represents a significant step forward in the treatment of TED, offering hope for a new oral therapy that could simplify and enhance patient care. By potentially reducing the need for more invasive and burdensome treatments, linsitinib could improve the quality of life for many individuals living with this challenging condition. Sling Therapeutics continues its commitment to advancing the clinical program for linsitinib, with the goal of providing a new standard of care for TED patients worldwide.