Novo Nordisk is facing generics of its GLP-1 drug in India, Atrogi is testing a new weight loss approach, and there’s new data on Structure’s lead drug.
Indian patent on semaglutide expires tomorrow
Novo Nordisk is facing a massive wave of generic competitors to its injectable formulations of GLP-1 agonist semaglutide, used to treat diabetes and obesity, as a key patent in India is due to expire on Friday. The Indian diabetes medicine market is a massive, rapidly expanding sector driven by over 100 million patients, making it one of the largest in the world.
A Reuters report suggests that around 40 generic manufacturers are poised to launch dozens of copycat semaglutide formulations within the next few weeks, including Sun Pharma, Dr Reddy’s, Zydus, and Lupin.
Some analysts are predicting prices will be set at a 60% to 70% discount to Novo’s branded products, sold as Wegovy for weight loss and Ozempic for type 2 diabetes, and the availability of cheaper alternatives could also affect Novo’s main rival in the category, Eli Lilly, and its dual GIP/GLP-1 agonist Mounjaro (tirzepatide).
Jefferies has predicted that the availability of lower-priced generics could help drive a big expansion in the Indian semaglutide market, currently limited by affordability issues, to a value of more than $1 billion, according to a BBC article. Meanwhile, India’s huge generic drugs sector will now be poised to serve the needs of other markets as semaglutide patents expire elsewhere.
Atrogi starts trial of its ‘exercise-in-a-tablet
Swedish startup Atrogi has started dosing patients in the first human trial of its novel approach to weight loss, which promises to deliver fat loss, muscle gain, and improved metabolism with a single tablet, that will examine its physiological effects.
The drug, called ATR-258, is a GRK-selective long-acting beta2-agonist suitable for once-daily oral dosing that was shown in a recent scientific paper to stimulate growth of skeletal muscle in a manner similar to exercise, whilst avoiding cardiovascular risks associated with other beta-agonist medicines. The study, published in Cell, also included phase 1 safety testing results, which showed that it was well-tolerated in healthy patients as well as those with type 2 diabetes.
Atrogi’s new eight-week study will enrol around 10 overweight male volunteers and will measure ATR-258’s effects on muscle physiology using biopsies, scanning, and molecular biomarkers. The company aims to develop the drug as a companion to weight-loss therapies targeting GLP-1 and other incretins, which are known to lead to a loss of muscle mass. Results are due before the end of this year, according to the study’s listing on the clinicaltrials.gov registry.
Structure Therapeutics claims best weight loss with oral GLP-1
Structure Therapeutics has reported that its oral GLP-1 agonist aleniglipron achieved 16% weight loss in the phase 2 ACCES II trial after 44 weeks’ treatment, which it maintains is the best result seen with an oral GLP-1 and is in the same ballpark as injectable therapies. There was a 1.1% weight gain for the placebo group in the study.
The biotech is now planning to start a phase 3 trials programme for aleniglipron in the latter half of this year, as it tries to catch up with the leaders in the oral GLP-1 category. Novo already has FDA approval for its pill formulation of Wegovy, while Lilly is expecting a decision from the US regulator on its orforglipron candidate in the next few weeks.
