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.
Neuren Pharmaceuticals Ltd.’s NNZ-2591 met the primary endpoints in a phase II trial in children with Pitt Hopkins syndrome, with improvements seen in communication, social interaction, cognition and motor abilities, according to top-line results.
Neuren Pharmaceuticals Ltd.’s NNZ-2591 met the primary endpoints in a phase II trial in children with Pitt Hopkins syndrome, with improvements seen in communication, social interaction, cognition and motor abilities, according to top-line results.
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