Dubbed the LIDS trial (NCT05276063), the primary endpoint of the study was the percentage of subjects who were proptosis responders at week 24. Credit: Shutterstock /Garna Zarina

Michigan late-stage biopharma, Sling Therapeutics, said a Phase IIb/III LIDS trial of its oral small molecule therapy designed to treat thyroid eye disease (TED) met its primary endpoint.

A trial of the company’s lead therapeutic candidate linsitinib found that it was able to significantly reduce the rate of proptosis, the bulging of the eyes, whilst maintaining a consistent safety profile and avoiding potential adverse events (AEs) commonly associated with TED treatment such as tinnitus or hearing loss.

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The LIDS trial (NCT05276063), enrolled and randomised 90 patients to receive either linsitinib 150mg twice daily, linsitinib 75mg twice daily, or placebo for 24 weeks.

The primary endpoint was proptosis responder rate (PRR) at week 24, defined as at least a two-millimetre reduction in proptosis from baseline. PRR was statistically significant and clinically meaningful at the 150mg twice daily dose, with a PRR of 52% at week 24.

Ryan Zeidan, president and CEO of Sling Therapeutics, said: “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.

“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 III registrational trial later this year.”

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Only 3% of the 900 patients in the trial developed hyperglycaemia as an AE. Other treatment-emergent AEs included diarrhoea (20.7%), headache (20.7%), nausea (20.7%), fatigue (17.2%) and muscle spasms (10.3%).

Raymond Douglas, chief scientific officer at Sling Therapeutics, said: “In this trial, patients demonstrated significant improvement in disease with no drug-related hearing impairments or significant hyperglycaemia.

“Side effects are the largest barriers for current medical treatments, making linsitinib an important potential new therapy for patients with TED. As a practising 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.”

The company is meeting with regulatory authorities to discuss a confirmatory Phase III trial design, which is on track to commence in 2025, with complete results from the Phase IIb/III trial set to be released at an upcoming conference.

Meanwhile in the market of TED Viridian Therapeutics’s stock has jumped after a Phase III trial of veligrotug met all endpoints and was well tolerated in patients. At the same time, US-based Acelyrin has reported positive Phase II data for its monoclonal antibody lonigutamab in TED but was met with a bleak response by the biotech markets.