Higher doses of a Viking Therapeutics pill that targets two receptors led to greater weight loss without worsening safety or tolerability, according to Phase 1 results presented during the ObesityWeek conference. Meanwhile, an injectable version of this Viking drug is on track to Phase 3 testing.
In a Phase 3 study, Eli Lilly’s tirzepatide led to a 94% reduction in the risk that obese or overweight prediabetes patients progress to type 2 diabetes. Lilly was already planning to expand use of the blockbuster metabolic disorders drug to sleep apnea and heart failure.
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Roche reported its oral GLP-1 agonist led to an average 6.1% weight loss at four weeks, according to preliminary results from part of a Phase 1 study. The small molecule comes from Roche’s $2.7 billion acquisition of Carmot Therapeutics last year.
Skye Bioscience’s nimacimab blocks CB1, the same receptor targeted by an obesity drug candidate now in the hands of Novo Nordisk. But Skye contends its Phase 2-ready antibody drug has several advantages over the small molecule that joined Novo’s pipeline in a deal valued at $1 billion.
Eli Lilly says its capital commitment to its new Indiana site is the largest manufacturing investment in the company’s history. The site will make tirzepatide, the active pharmaceutical ingredient in both Zepbound and Mounjaro.
Novo Holdings’ $16.5 billion planned acquisition of Catalent is facing another delay. Just weeks after Novo decided to resubmit its application to the FTC, the agency is seeking more information about the deal. This move has triggered a second 30-day delay in the antitrust review process.
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Amgen is confident its injectable obesity drug would have a differentiated profile compared to medications now on the market from Novo Nordisk and Eli Lilly and it’s now preparing for Phase 3 testing. But an oral obesity drug in Amgen’s pipeline will not advance beyond Phase 1.
Blockbuster Novo Nordisk drug Ozempic now has clinical trial results showing statistically significant reductions in the risk of kidney disease progression. The company said these results support the expansion of the drug’s label to chronic kidney disease.
The weight loss achieved by Viking Therapeutics’ obesity drug tops results posted by Eli Lilly’s Zepbound in its pivotal test. But Viking still needs to show its results can hold up in a larger Phase 3 clinical trial.
Preliminary Phase 2 results show 83% of those treated with Boehringer Ingelheim and Zealand Pharma drug survodutide met the main goal of improvement in the fatty liver disease MASH. Boehringer contends this drug has best-in-class potential in a competitive field that includes an Eli Lilly drug that recently posted positive Phase 2 results.
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Eli Lilly reported 74% of patients treated with tirzepatide achieved resolution of metabolic dysfunction-associated steatohepatitis, or MASH. However, the Phase 2 results showed only “clinically meaningful” improvement in resolving liver fibrosis, a key measure of the drug's potential competitiveness in a crowded field of contenders.
After Novo Holdings acquires Catalent, it will sell three of the contract manufacturing giant’s sites to Novo Nordisk. Those facilities already make Novo Nordisk’s GLP-1 drugs for metabolic conditions, and they will help the company meet projected demand for these products in years to come.
Fractyl Health will use the IPO proceeds for pivotal testing of a medical device and surgical procedure intended to address root causes of diabetes and obesity. The Fractyl pipeline also includes a gene therapy for these conditions.
Roche’s Carmot Therapeutics acquisition brings three clinical-stage assets that the companies say could be best-in-class drugs for metabolic disorders. In addition to standalone use, Roche sees the Carmot molecules as part of potential combinations with its own drug candidates.
Novo Nordisk's planned expansion will more than double the footprint of its France production site, bringing new capacity for manfacturing GLP-1 drugs for metabolic conditions. The location is already one of the company’s largest for making diabetes products.