Sling Therapeutics has commenced subject enrolment in the international Phase IIb LIDS clinical trial of linsitinib to treat active, moderate to severe thyroid eye disease (TED).
The double-mask, randomised, placebo-controlled trial will enrol 75 adults in the US, Canada, UK, and Europe.
Individuals with a clinical diagnosis of Graves’ disease or autoimmune Hashimoto’s thyroiditis linked to active, moderate to severe TED will be part of the trial.
The trial will analyse the safety, pharmacokinetics and efficacy of orally twice a day dose of linsitinib in TED patients for 24 weeks.
The percentage of subjects who are proptosis responders is the primary endpoint of the trial.
Furthermore, the variation in proptosis and the Graves’ Ophthalmopathy Quality of Life (GO-QoL) questionnaire overall score from baseline will be assessed.
The percentage of subjects who are diplopia, CAS categorical and overall responders will be included as other secondary endpoints.
Linsitinib is a small molecule insulin-like growth factor I receptor (IGF-1R) inhibitor.
Sling Therapeutics president and CEO Ryan Zeidan said: “This is a significant milestone for patients and families who are impacted by TED because we believe linsitinib offers the potential to significantly reduce the treatment burden.
“The rapid initiation of our late-stage clinical trial in TED was made possible by the extensive preclinical and clinical development data in hand for linsitinib, including pre-clinical studies, toxicology studies, and pharmacokinetic and safety data collected from the over 800 oncology patients who have received linsitinib.”
A debilitating autoimmune disease, TED mainly impacts women and chiefly affects hyperthyroidism patients due to Graves’ disease.