Roche is expanding its scope to a promising but competitive new obesity target, committing $1.65 billion up front to partner on a clinical-stage Zealand Pharma molecule with the potential to be a standalone treatment and part of drug combinations for weight loss.
The deal announced Wednesday calls for the companies to share in the development and commercialization of the Zealand drug, petrelintide. The partners will co-commercialize the drug in the U.S. and Europe; Roche is gaining commercialization rights in the rest of the world. Milestone payments could bring Copenhagen-based Zealand up to $3.6 billion more, plus royalties from sales.
Petrelintide is part of an emerging class of drugs that bind to and activate the amylin receptor. The once-weekly injectable Zealand drug is a peptide engineered to be a long-acting version of amylin, a hormone in the body that plays a role in regulating blood sugar and appetite. Activating the amylin receptor is intended to restore sensitivity to leptin, a hormone that signals satiety. Rather than suppressing appetite, Zealand says its drug is helps patients feel full faster.
Zealand and other companies developing amylin drugs aim to spark weight loss comparable to GLP-1 drugs while offering better tolerability. Gastrointestinal side effects are common with GLP-1 drugs, leading many patients to stop treatment. Also, the weight loss from these drugs includes muscle as well as fat. Targeting amylin is hoped to preserve muscle.
In a 16-week Phase 1 clinical trial, Zealand reported petrelintide led to an average 8.3% loss in body weight for the highest of three doses tested versus 1.7% average weight loss for the placebo group. All gastrointestinal adverse events were mild, except for two moderate nausea and vomiting events reported in one participant who discontinued treatment.
In December, Zealand began a Phase 2 test that will evaluate five target doses of petrelintide for 42 weeks in patients with obesity or overweight without type 2 diabetes. The company expects to complete enrollment in the 480-patient study in the first half of this year. That’s also the timeline for starting a separate mid-stage test enrolling patients with obesity or overweight with type 2 diabetes.
Roche entered the obesity drug chase with its $2.3 billion Carmot Therapeutics acquisition in 2023. Lead program CT-388 is a peptide designed bind to and activate both GLP-1 and GIP, the same receptors hit by Eli Lilly obesity drug Zepbound. But the Carmot drug is engineered with “biased signaling” that de-emphasizes pathways that could diminish tolerability and efficacy.
CT-388, administered as a once-weekly injection, is currently in mid-stage clinical development. Zealand engineered petrelintide in a way that enables it to be co-formulated and co-administered with other peptide drugs. Roche is interested in additional testing of CT-388 with petrelintide to see if the combination offers better efficacy and tolerability.
“We share the vision to develop petrelintide as a future foundational therapy,” Roche Pharmaceuticals CEO Teresa Graham said in a prepared statement. “By combining petrelintide with our pharmaceuticals portfolio and with our diagnostics expertise in cardiovascular and metabolic diseases, we are aiming to transform the standard of care and positively impact patients’ lives.”
In a note sent to investors, William Blair analyst Andy Hsieh said the Roche/Zealand partnership represents the highest total financial consideration in the obesity field with the largest upfront payment for a single asset. The deal is more than money. Roche is taking on the responsibility of manufacturing and supplying petrelintide, including future capital expenses required for commercialization. Manufacturing challenges contributed to GLP-1 drug shortages that were only recently resolved. Hsieh said the importance of securing manufacturing capabilities is evident in the multi-year contract announced this week that calls for CordenPharma to provide development and manufacturing services for Viking Therapeutics’ obesity drugs.
“Taken together, with Roche’s clinical development prowess and global commercial infrastructure, we now hold a more bullish view on the prospect of petrelintide emerging as an important therapeutic intervention for chronic weight management,” he said.
Amylin has become a hot target for companies aiming to develop the next generation of obesity drugs. Last week, AbbVie joined the field by securing global rights to an engineered peptide Gubra developed to hit the amylin and calcitonin receptors. This once-weekly injection is currently in Phase 1 testing.
Novo Nordisk has two contenders in the amylin chase. Amycretin is a single peptide engineered to bind to and activate the amylin and GLP-1 receptors. Meanwhile, CagriSema is a combination of two peptides, one for the GLP-1 receptor and the other for amylin. On Monday, Novo Nordisk reported CagriSema met the goal of a Phase 3 test in patients with obesity and type 2 diabetes. But these results disappointed investors who were hoping for stronger differentiation from Lilly’s Zepbound. Other companies in earlier stages of development with amylin receptor-targeting drugs include Metsera and Viking.
Photo: Giuseppe Aresu/Bloomberg, via Getty Images
