Dive Brief:
- An experimental obesity drug from Boehringer Ingelheim and Zealand Pharma succeeded in a mid-stage liver disease study, the latest evidence new weight loss medicines could also help people with metabolic dysfunction-associated steatohepatitis, or MASH.
- Summary results disclosed Monday show that up to 83% of trial participants treated with the companies’ drug, survodutide, experienced a significant improvement in their disease without worsening liver scarring, compared to about 18% of those given placebo. The drug met its secondary study goals, notably demonstrating a benefit on liver scarring, the companies said.
- Boehringer and Zealand didn’t provide many other details, leaving unanswered questions about the magnitude of survodutide’s effect. The companies also didn’t describe safety findings in depth, although they noted treatment “did not show unexpected safety or tolerability issues” at any of the three doses tested. Data will be presented at an upcoming medical meeting.
Dive Insight:
In recent years, drugs known as incretins have become the industry’s most coveted products, proving able to treat diabetes, help people to lose weight and even protect heart health.
Clinical trial results like those from Boehringer and Zealand are now indicating incretins may play a role treating MASH, a disease estimated to affect millions of people and one of the leading causes of liver transplants.
MASH is caused by a toxic build-up of liver fat, and often develops alongside other metabolic diseases like diabetes. While it has long been a top drug target, it’s proven difficult for companies to crack. Several promising prospects have failed in advanced testing and the first to reach regulators — a medicine from Intercept Pharmaceuticals — was rejected last year.
A newer crop of medicines has followed. A MASH drug from Madrigal Pharmaceuticals could win regulatory approval by mid-March, for example. Other medicines from Akero Therapeutics and 89bio have shown some promise, too, though study results haven’t been as clear.
Yet they could be undercut by incretins. Earlier this month, Eli Lilly said tirzepatide, the drug it sells as Zepbound for weight loss, met its goal in a Phase 2 MASH study. At the time, Raymond James analyst Steven Seedhouse described the findings as the “best any [MASH] drug has ever shown in Phase 2 or Phase 3.”
Boehringer and Zealand’s drug, survodutide, may be another competitor. The drug, which the two companies are also developing for obesity, works somewhat differently than tirzepatide or Novo Nordisk’s Wegovy. Like those drugs, survodutide activates an insulin-regulating hormone called GLP-1. But the drug also targets a receptor controlling the hormone glucagon, which could be useful for treating MASH because it increases the liver’s metabolic rate.
The summary results disclosed so far are “roughly in line” with what Lilly reported, which may “lead to some pressure on [MASH]-focused companies,” Leerink Partners analyst Thomas Smith wrote in a client note.
But he and Jefferies analyst Michael Yee highlighted several caveats that make the findings harder to interpret. While comparing drugs across trials is difficult, Boehringer’s study had “less stringent” goals than the endpoints used by Lilly and others, Yee wrote. The company also enrolled a healthier study population, while its bar for declaring a liver scarring improvement is lower than in other trials, he added.
Fuller safety data are also needed to properly assess the results, Smith wrote.
Three Phase 3 studies of survodutide are underway in obesity. Results could come in 2025 and 2026, according to a federal database.