Amycretin has some intriguing results in obesity

Amycretin, an experimental Novo Nordisk obesity pill that targets both amylin and GLP-1 receptors, spurred significant weight loss in a Phase 1 study, the company announced yesterday. Over three months, a daily dose resulted in 10.4% loss in weight; those who took two pills lost 13.1% of their body weight. By comparison, the people taking placebo experienced only 1.1% weight loss. Animal studies suggest that targeting amylin could mean less nausea and muscle loss than GLP-1, but that has yet to be proven in clinical trials.

"This is one of the most promising biologies that we've seen in a number of years," Martin Lange, Novo's head of development, told STAT. "Obviously GLP-1, specifically the longer-acting GLP-1s, have changed the field of obesity and diabetes. And when we combine the GLP-1 and the amylin biology, there is a potential to see even further weight loss."

obesity

The impact of GLP-1 drugs in kids

Saxenda, also a Novo Nordisk drug, resulted in a 5.8% BMI decrease in children aged 6 to 12 — compared to a 1.6% decrease in the placebo group. This suggests Saxenda could help young children, but it also raises concerns about the use of the medicine in young people, particularly when it comes to gastrointestinal side effects and mental health. This could be particularly problematic in children with eating disorders.

"You're talking about a child 7 years of age. If you get them into the normal range or desirable range for BMI, one can expect that child on average to live another 70, 80 years to be on a GLP-1 or similar medication for that length of time," an expert in this space told STAT's Elaine Chen and Elizabeth Cooney. "I mean, we just don't know what the long-term consequences of that are."

autoimmune Disease

The future of autoimmune drugs in hives

Dupixent, a blockbuster from Sanofi and Regeneron, treated patients with chronic spontaneous urticaria in a Phase 3 trial — showing a significant decrease in itch severity and hives compared to placebo.

The study, Liberty-Cupid Study C, found that 30% of Dupixent-treated patients were hive- and itch-free after six months, versus 18% on placebo, with similar safety profiles between the groups. These results come after the FDA rejected Dupixent's application last year, requesting additional data following a failed trial.

diabetes

Lilly releases new data on weekly insulin

From STAT's Elaine Chen: Eli Lilly reported more data on its weekly insulin, efsitora alfa. In a Phase 3 trial of type 1 patients, the drug met the primary endpoint of non-inferior A1C reduction compared with a daily insulin called degludec.

But efsitora also led to a higher rate of hypolgycemic events, or cases of dangerously low blood sugar — 14.03 events per patient year of exposure, compared with 11.59 events among patients on degludec. Additionally, 10% of patients on efsirotra experienced severe hypoglycemia, versus 3% of patients on degludec.

While Lilly's weekly insulin has shown in previous trials that it works in type 2 patients without causing a significant increase in hypoglycemic events, the new data raise questions about the safety of its use in type 1 patients.

This is similar to what's been seen with Novo Nordisk's weekly insulin, icodec. The FDA recently rejected Novo's drug, in part due to questions around its use in type 1 patients.

In an interview, Paul Owens, vice president of global brand development for insulins and glucagon at Lilly, wouldn't say what the company's plans and timeline for regulatory submissions are, "but we remain confident in the potential of a once weekly insulin compared to daily insulin."

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