The company announced it has received FDA IND clearance for linsitinib and prepares to initiate Phase 2b clinical trial.
Sling Therapeutics Inc. today announced the debut of the company with $35 million to develop an oral small molecule for thyroid eye disease (TED). TPG’s The Rise Fund led the Series A that will enable the company to execute a Phase 2b study.
According to a news release, the partners already have IND clearance from the FDA. The funds will support a Phase 2b clinical trial evaluating the company’s investigational drug, linsitinib, for the treatment of TED.
Ryan Zeidan, PhD, president and CEO of Sling Therapeutics, said the company will be launched with a clinical development program that is based on an extensive amount of data with over 800 patients having received linsitinib in cancer clinical trials, which allows us to accelerate development of linsitinib in TED.
“Linsitinib will be the first oral IGF-1R inhibitor to enter late-stage clinical trials for TED and we have the potential to bring a convenient orally administered drug to patients,” Zeidan said in the news release. “We are pleased to have received IND clearance from the FDA and are initiating a Phase 2b study.”
Zeidan added in the release that the goal is to significantly reduce the treatment burden for patients and the healthcare system compared to currently marketed products.
The company noted in the release that TED is a debilitating autoimmune disease that affects about 20,000 people in the US each year and has a similar prevalence in Europe. The immune system mistakenly attacks the muscle and fat tissue behind the eyes, causing inflammation and scar tissue to form. 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, double vision, and a profound reduction in quality of life. TED predominantly affects women, and most frequently affects people with hyperthyroidism due to Graves’ disease.
Linsitinib, which was in-licensed from Astellas Pharma to Sling Therapeutics, is designed to inhibit the insulin-like growth factor I receptor (IGF-1R). 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 in TED. Independent data from a model of TED in patient fibroblast cells suggest that linsitinib is at least as potent as currently available treatment.
The U.S. Food and Drug Administration (FDA) cleared an Investigational New Drug (IND) application for linsitinib for the treatment of TED, and Sling Therapeutics is initiating a Phase 2b clinical trial. The company is also exploring additional potential indications beyond TED, including in rare and autoimmune diseases.
Peter Bojo, a principal at TPG Life Sciences Innovation, and Lucian Iancovici, MD, managing director at TPG Life Sciences Innovation, will be joining the Board of Directors on behalf of The Rise Funds and are working closely with management to launch the company.
Zeidan was previously the chief development officer at Millendo Therapeutics and held various positions at Celgene and Novartis where he led research and development activities for late-stage assets, including rare diseases, oncology, and vaccines.
According tot eh news release, Sling Therapeutics is a biopharmaceutical company focused on late-stage development of an oral small molecule for the treatment of thyroid eye disease (TED).
Also joining the Sling Therapeutics management team is Robin Schmidt as chief operating officer. She has more than 25 years of experience in clinical trial strategy and execution across large pharma, biotech and CROs. She is the former vice president of clinical operations at Millendo Therapeutics.
Catherine Radovich will serve as vice president of clinical operations with more than 25 years’ experience in clinical trial execution and data delivery with large pharma, biotech, academic, and CROs. She previously served as the director of clinical operations at Millendo Therapeutics and is the former director of the administrative program at the Michigan Institute for Clinical and Health Research.
Ronald Dadino is vice president of CMC and Manufacturing. He has more than 35 years of experience in the development, manufacturing, and commercialization of pharmaceutical products.