Sling Therapeutics Initiates Enrollment in Phase 2b LIDS Clinical Trial Evaluating Linsitinib in Thyroid Eye Disease

- First oral IGF-1R inhibitor to enter late-stage clinical trials for thyroid eye disease –

- Global study being conducted in the U.S., Canada, UK, and Europe -

ANN ARBOR, MI, USA I July 25, 2022 I Sling Therapeutics, Inc., a biopharmaceutical company focused on late-stage development of an oral small molecule for the treatment of thyroid eye disease (TED), today announced the initiation of enrollment in the global Phase 2b LIDS clinical trial evaluating the safety, pharmacokinetics and efficacy of linsitinib, a small molecule insulin-like growth factor I receptor (IGF-1R) inhibitor, in the treatment of active, moderate to severe TED.

"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," said Ryan Zeidan, Ph.D., President and Chief Executive Officer of Sling Therapeutics. "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."

TED is a debilitating autoimmune disease that affects about 20,000 people in the U.S. per year and has a similar prevalence in Europe. Dysfunction in the IGF-1R signaling pathway leads to a prevalence of thyroid-stimulating hormone receptor autoantibodies (TSHR-Abs) that drive excess fibrous tissue growth behind the eyes. The inflammation can push the eyes forward or cause the eyes and eyelids to become red and swollen. As the disease progresses it can lead to pain, eye bulging, and double vision. TED predominantly affects women, and most frequently affects people with hyperthyroidism due to Graves' disease.

"When the body's immune system mistakenly attacks the muscle and fat tissue behind the eyes, it can cause inflammation and scar tissue formation that has a profound impact on the quality of life for people suffering from TED," said Raymond Douglas, M.D., Ph.D., board-certified aesthetic and reconstructive oculoplastic surgeon in Beverly Hills, California. "As one of the lead scientists in the development of the only currently approved treatment for TED, I am excited to see this study advance with the hope of providing additional options for patients."

"Dysfunction in the IGF-1R signaling pathway that drives excess fibrous tissue growth is well known and understood," said George J. Kahaly, M.D., Ph.D., professor of medicine and endocrinology/metabolism at the Johannes Gutenberg University Medical Center in Mainz, Germany. "I have experienced many of the challenges with current treatment options that place a burden on patients, caregivers, and physicians while serving as chair of the ORPHAN referral expert center for TED. There is a need for a more convenient drug therapy."

The randomized, double-mask, placebo-controlled Phase 2b LIDS clinical trial is designed to enroll 75 adult participants in the U.S., Canada, UK, and Europe with 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. The primary endpoint is the percentage of participants who are proptosis responders. Researchers will also evaluate the change from baseline in proptosis and in the Graves' Ophthalmopathy Quality of Life (GO-QoL) questionnaire overall score. Additional secondary endpoints include the percentage of participants who are diplopia responders, CAS categorical responders, and overall responders.

For more information about the Phase 2b LIDS clinical trial visit https://clinicaltrials.gov/ct2/show/NCT05276063.

About Sling Therapeutics

Sling Therapeutics, Inc., is a biopharmaceutical company focused on late-stage development of an oral small molecule for the treatment of thyroid eye disease (TED). The company is advancing the evaluation of its lead product candidate, linsitinib, in a Phase 2b clinical trial based on extensive preclinical and clinical data. Linsitinib offers the potential of a convenient oral small molecule that could significantly reduce the treatment burden for people living with TED. For more information visit https://slingtx.com/.

SOURCE: Sling Therapeutics

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