Sling Therapeutics Inc. in Ann Arbor, a clinical-stage biopharmaceutical company, has closed $123 million in Series C financing to support the development of an oral medication for thyroid eye disease (TED).
TED is a serious, progressive, and vision-threatening rare autoimmune disease that is estimated to affect more than 200,000 people in the U.S.
Sling Therapeutics says it’s developing Linsitinib, the first and only late-stage oral small-molecule therapy for TED. Proceeds from the financing will support the continued clinical advancement of the medication.
The financing was led by Forbion in the Netherlands and included participation from existing investor TPG Life Sciences Innovations in San Francisco and new investor Sectoral Asset Management in Montreal.
“This financing reinforces our conviction in Linsitinib’s potential to transform the treatment landscape for people living with TED as the first and only oral IGF-1R inhibitor in late-stage development,” says Ryan Zeidan, president and CEO of Sling Therapeutics.
“The data generated to date give us confidence in Linsitinib’s potential to meaningfully address important limitations of current TED therapies and offer patients an effective, convenient oral treatment option that could be used earlier and more broadly in the treatment journey. With the support of a high-quality investor syndicate, we are well positioned to advance Linsitinib toward commercialization with urgency and purpose for the TED community.”
Sling has started the global Phase 3 ORBIT pivotal trial for adults with moderate to severe active TED. Alignment on the pivotal Phase 3 study design was secured during a successful End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) earlier this year.
The Phase 3 ORBIT trial builds on Sling’s previously completed Phase 2b/3 LIDS trial, which met its primary endpoint of proptosis (eye bulging) reduction in patients with moderate-to-severe TED and exhibited a differentiated safety profile, particularly in IGF-1R areas of interest such as hearing impairment, glycemic changes, and menstrual cycle changes.
As a result of these data and recognition from the FDA that TED is a serious disease in which patients could benefit from new treatment options beyond what is currently available, Linsitinib was granted Fast Track designation.
Therapies with Fast Track designation receive more frequent interactions with the FDA regarding a designated drug’s clinical development program, alongside eligibility for Rolling Review, Accelerated Approval, and Priority Review, if relevant criteria are met.
For more information about Sling Therapeutics, visit slingtx.com.
In Related News: The first patients have been dosed with Linsitinib in the global Phase 3 ORBIT trial of the medication. The trial is a global, randomized, double-masked, placebo-controlled study evaluating the efficacy and safety of Linsitinib.
“ORBIT represents the next step toward what we believe could be a meaningful advancement in the treatment of TED,” says Zeidan. “Linsitinib has already demonstrated the potential to deliver clinically meaningful improvements in proptosis with a differentiated safety profile, and it does so as an oral therapy — an important distinction in a treatment landscape currently defined by infused biologics.”
ORBIT is expected to enroll approximately 130 participants, randomized 1:1 to receive oral Linsitinib 150 mg or placebo twice daily for 24 weeks. Following the 24-week double-masked placebo-controlled treatment period, patients will be eligible to enroll in a 24-week open-label extension. For more information, visit clinicaltrials.gov (identifier: NCT07753603).
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