Neuren Pharmaceuticals Ltd.’s NNZ-2591 met the primary endpoints in a phase II trial in children with Angelman syndrome, with improvements seen in clinically important aspects of the disease, including communication, behavior, cognition and motor abilities, Neuren CEO Jon Pilcher said during an Aug. 9 conference call.
Armed with $55 million in series A funds and a U.S. government contract, Cambridge, Mass.-based Red Queen Therapeutics Inc. launched operations this week, with plans to advance its novel stapled lipopeptide platform, which creates new antiviral therapies that do not rely on the immune system to work.
Viking Therapeutics Inc. is diving more deeply into developing obesity treatments and investors like an accelerated timetable the company has proposed. On June 25, Viking shares (NASDAQ:VKTX) catapulted 28.3% upward to close at $64.68 each.
Long-acting glucagon-like peptide-1 receptor (GLP-1R) agonists have shown efficacy in obesity treatment but, after discontinuation, a rapid recovery of weight is usually seen, likely due to orexigenic mechanisms involved in weight regain.
Gan & Lee Pharmaceuticals’ long-acting GLP-1 receptor agonist (GLP-1 RA), GZR-18, achieved as much as 17.29% weight loss in a phase IIb trial in obese and overweight Chinese patients. Developed independently by Shanghai-based Gan & Lee, GZR-18 is a once-weekly or potentially biweekly GLP-1 RA being developed to treat adults with type 2 diabetes and for weight management for obese or overweight patients.
Nexthera Co. Ltd. has submitted an IND application to the FDA seeking to conduct a phase I/IIa trial with NT-101, a noninvasive eye drop treatment for wet age-related macular degeneration (AMD).
Following an advisory committee’s recommendation in May against approval, the U.S. FDA issued a complete response letter (CRL) to Novo Nordisk A/S for its once-weekly insulin icodec injection for diabetes, which is on the market as Awiqli in several other countries.
Amylyx Pharmaceuticals Inc.’s acquisition of GLP-1 receptor antagonist avexitide for $35.1 million from Eiger Biopharmaceuticals Inc. could bring the firm “to the forefront of the obesity and diabetes drug landscape in a unique way,” said H.C. Wainwright analyst Andrew Fein. Co-CEO and co-founder Justin Klee said the deal came after Amylyx checked out “hundreds of assets” over the last few years, and its closing brought added attention to phase III-ready, first-in-class avexitide.
The obesity market is hot with Novo Nordisk A/S generating $6.3 billion in sales from its semaglutide-containing drugs, Ozempic, Saxenda, Rybelsus and Wegovy, in the first quarter of 2024 and Eli Lilly and Co. bringing in $2.3 billion for its tirzepatide-containing drugs, Zepbound and Mounjaro, in the same quarter. It appears unlikely the market will be a two-horse race for much longer though.
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