Sciwind Biosciences Co. Ltd.’s injectable glucagon-like peptide-1 (GLP-1) analog, ecnoglutide (XW-003), achieved positive top-line results in a phase III trial in Chinese adults with type 2 diabetes. A long-acting, cAMP signaling biased GLP-1 analog, ecnoglutide is being developed for treating type 2 diabetes and obesity. GLP-1 receptor agonists are increasingly gaining attention in the obesity therapy area.
Given what CEO Raymond Stevens called a space that’s “evolving extremely rapidly,” Structure Therapeutics Inc. chose – rather than wait for next year’s 12-week data – to unblind the eight-week obesity findings with GSBR-1290, an oral glucagon-like peptide-1 (GLP-1) agonist for which the firm also provided a phase IIa update in patients with type 2 diabetes.
Biomea Fusion Inc.’s diabetes treatment produced enhanced glycemic control at week 26 courtesy of its 200-mg cohort. It’s the latest advance for the company’s candidate that also has strong prospects in treating leukemia. Top-line data from the ongoing phase II Covalent-111 study of BMF-219, a covalent menin inhibitor for regenerating insulin-producing beta cells, demonstrated that about 40% of participants, four of 11 patients, in the 200-mg cohorts showed a durable reduction, 1% or more, in the amount of blood sugar attached to the type 2 diabetes (T2D) patients’ hemoglobin. The data came from participants who had received the last dose in a four-week treatment.
The same mechanism of action deployed by Eli Lilly and Co.’s obesity drug Mounjaro (tirzepatide) helped lure Roche Holding AG to the buyout of Carmot Therapeutics Inc., as the pharma giant agreed to pay $2.7 billion up front for the privately held outfit, promising another $400 million if milestones are met.
Astrazeneca plc will pay up to $2 billion for Eccogene Co. Ltd.’s oral weight loss candidate, ECC-5004, as big and small pharma players alike work to gain ground in the burgeoning obesity market where Eli Lilly and Co. scored the latest U.S. FDA approval of Zepbound (tirzepatide).
Orsobio Inc., already in the clinic with three candidates, has completed its $60 million series A financing. The company, CEO Mani Subramanian told BioWorld, has taken its time to find the right programs, put them together and only raised capital when it saw the programs had legs. Even the series A is a measured step, as Subramanian called the financing “modest.”
A year-and-a-half after Eli Lilly and Co.’s Mounjaro (tirzepatide) gained U.S. FDA approval for adults with type 2 diabetes, the GLP-1 and GIP dual agonist was cleared for chronic weight management in adults who are obese or overweight and who also have one related condition.
Novo Nordisk A/S’ semaglutide is making headlines again this week, with a phase IIIb testing the ubiquitous GLP-1 agonist on kidney outcomes halted early for efficacy. The independent data monitoring committee for the trial, dubbed Flow, concluded results from an interim analysis met prespecified efficacy criteria. Final data will read out in the first half of 2024.
Safety concerns overrode benefit when the U.S. FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted unanimously, 19-0, Sept. 21 that the potential risks of Intarcia Therapeutics’ ITCA-650 outweighed the compliance and A1C-lowering benefits the twice-yearly implantable exenatide-device combination product could provide for adults with type 2 diabetes.
A Sept. 21 U.S. FDA advisory committee meeting will either be a “Hail Mary” or a last gasp of life for ITCA-650, a twice-yearly implantable exenatide-device combination product intended to improve glycemic control in adults with type 2 diabetes.
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