Teprotumumab-TRBW

Sling Therapeutics has closed a $123-million series C round as it advances linsitinib into Phase III testing for thyroid eye disease (TED), putting the oral small-molecule IGF-1R inhibitor on track to challenge infusion-based therapies including Amgen's Tepezza (teprotumumab-trbw) and Viridian Therapeutics' Lumvoa (veligrotug-vvze). The financing, led by Forbion with participation from TPG Life Sciences Innovations and new investor Sectoral Asset Management, comes as Sling begins dosing patients in the pivotal ORBIT trial. ORBIT is enrolling approximately 130 adults with moderate-to-severe active TED who will be randomised to linsitinib 150 mg or placebo twice a day for 24 weeks. The primary endpoint is the proportion of proptosis responders, defined as at least a 2-mm reduction in proptosis in the study eye without a corresponding worsening in the fellow eye. Secondary measures include overall response, Clinical Activity Score (CAS) and quality of life. CEO Ryan Zeidan told FirstWord the financing leaves the company "well supported to continue clinical advancement of linsitinib through our registrational Phase III trial and begin early commercialisation planning." The pivotal study follows the Phase IIb/III LIDS trial, in which linsitinib produced a 52% proptosis responder rate, though that was lower than the 71-83% rates seen in Tepezza's pivotal trials, while Lumvoa achieved a 70% response rate in Phase III. "Response rate is one input into a much broader clinical decision that physicians and patients take on," Zeidan said. "In LIDS, linsitinib met its primary endpoint and reduced proptosis, and it did so with a highly differentiated safety profile in the IGF-1R areas of interest, including hearing loss, hyperglycaemia and menstrual changes... There's a long history of oral medications becoming a preferred choice in legacy injectable markets." "The bigger opportunity," according to the CEO, "is reaching patients who would never get to an IV or a biologic at all, patients who go untreated today." Sling is looking to differentiate linsitinib on durability as well. ORBIT includes a 24-week open-label extension following the placebo-controlled treatment period that could provide data on the persistence of the drug's effects. Zeidan also argues that the convenience of an oral drug goes beyond simply cutting the number of treatment visits. Lumvoa has already narrowed the gap with Tepezza by requiring only five infusions over its treatment course rather than eight. However, intravenous therapy is still typically concentrated among a narrow set of specialists and infusion centres, limiting access for patients outside major metro areas. "A daily oral therapy will be used with oculoplastic surgeons, which is the current prescriber base, but also may extend the base to community ophthalmology and endocrinology," Zeidan said, "meaning patients can be treated closer to home by physicians they may already be seeing. This materially reduces time and travel and simplifies treatment logistics." The financing comes amid growing interest in oral IGF-1R inhibition for TED. Khartis Therapeutics recently emerged from stealth with $95 million to develop a selective oral small-molecule IGF-1R inhibitor for the disease, with plans to move its lead programme toward the clinic in early 2027. Zeidan said the emergence of additional oral IGF-1R programmes "validate[s] the target and the direction of the field," but highlighted Sling's lead in clinical development. "Linsitinib is the only late-stage oral IGF-1R inhibitor in Phase III development," he said. The content above comes from the network. if any infringement, please contact us to modify.