Building out its metabolic franchise, Novo Nordisk A/S is buying privately held Montreal-based Inversago Pharma Inc. for up to $1.075 billion, gaining lead asset INV-202, an oral cannabinoid 1 (CB1) inverse agonist. The candidate has demonstrated weight loss potential in a phase Ib trial and is currently in a phase II for diabetic kidney disease. Novo Nordisk’s interest in INV-202 is to explore its potential for obesity and obesity-related complications.
Investors have known for some time that the GLP-1 receptor agonist class offers tremendous promise for treating the underserved obesity population worldwide, but news from Novo Nordisk A/S on cardiovascular outcomes data sent a shiver throughout the space on Aug. 8. Top-line results from the Select trial comparing subcutaneous once-weekly Wegovy (semaglutide) 2.4 mg with placebo showed the treatment reduced major adverse cardiovascular events by a statistically significant 20%.
South Korean pharmaceutical company Hanmi Pharmaceutical Co. Ltd. may have found its footing after its misstep with Sanofi SA in 2020 for efpeglenatide, its glucagon-like peptide-1 (GLP-1) receptor agonist. On July 31, Hanmi announced that the once-dropped drug would be developed to treat obesity in the Korean population, submitting an IND application to the MFDS on July 28 to examine the once-a-week injection efpeglenatide in a phase III trial.
To bolster its obesity treatment pipeline, Eli Lilly and Co. is buying Versanis Bio Inc. in a massive cash deal that could reach $1.92 billion. The total amount of the deal includes an up-front payment and development and sales milestone payments. Privately held Versanis, of Boston, brings to Lilly its lead asset bimagrumab, a monoclonal antibody that’s enjoying a resurgence since a failure in treating sarcopenia.
Sino Biopharmaceutical Ltd. formed a partnership with Gmax Biopharm International Ltd. to develop obesity candidate GMA-106. As part of the $57 million deal, Sino Biopharm acquired greater China rights to develop and commercialize the drug, in exchange for up-front and milestone payments to Gmax.
Mixing a trendy drug for a global health problem like obesity with a demand that far exceeds the supply cooks up a recipe too good for counterfeiters to ignore. That’s the problem patients are facing with Novo Nordisk A/S’ semaglutide products, Ozempic and Wegovy, which have been in short supply all over the world since early last year due to significant, and unexpected, demand for weight management.
Swiss biopharma startup Aphaia Pharma AG is taking the concept of “location, location, location” to its extreme. The company started dosing patients in a phase II trial of its lead candidate, Aph-012, in late April, 2023. The trial is a randomized, double-blind, placebo-controlled, multicenter proof-of-concept study to evaluate Aph-012’s ability to improve glucose tolerance in individuals with prediabetes, as measured by a pathological oral glucose tolerance test. In another phase II trial, Aph-012 is being tested as a weight loss drug for individuals with a BMI between 30 and 40. Aph-012’s active ingredient? Glucose. But delivered exactly to the right place.
Positive phase III results from Surmount-2 of Eli Lilly and Co.’s Mounjaro (tirzepatide) showed overweight and obese type 2 diabetes patients receiving the highest dose lost up to 34.4 pounds, with the majority achieving at least a 5% decrease in overall body weight. The results will help the Indianapolis-based company complete its rolling supplemental NDA with the U.S. FDA targeting an approval for obese and overweight adults with weight-related co-morbidities.
In collaborating with Novo Nordisk A/S, privately held Aspect Biosystems Ltd. entered its biggest ever deal that could bring in more than $2.6 billion while advancing its 3D, bioprinted tissue therapeutics technology. The two companies will collaborate to develop up to four diabetes and/or obesity products, a Novo specialty, using implantable bioprinted tissues to replace, repair or supplement human biological functions. The initial target will be type 1 diabetes.
Metabolic health is at an odd juncture. With the advent of glucagon-like peptide (GLP-1) agonists, pharmacologically induced weight loss has matured into a viable therapeutic option at long last. GLP-1R agonists, which are also called incretin mimetics and GLP-1 analogs, are likely to continue their success across multiple areas of medical care. Already, the class has transformed diabetes care, making a splash in weight management, and it may yet do the same for other indications.
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