Frank Vinluan
Eli Lilly showed a drug that goes after two metabolic targets to treat obesity can successfully shed weight and become a revenue-generating heavyweight. Other companies aspire to improve on the Lilly drug’s approach and Kailera Therapeutics is the newest of them, backed by $400 million to support a pipeline of obesity drug candidates.
Kailera, which splits its operations between San Diego and Waltham, Massachusetts, is joining a growing field of companies developing drugs that mimic peptides in the body, binding to and activating receptors to spark metabolic effects. The company’s lead program goes after GLP-1 and GIP, targets addressed by Lilly’s blockbuster drug Zepbound, which won FDA approval for chronic weight management last November.
Kailera’s portfolio of four metabolic disorder dugs comes from China-based Jiangsu Hengrui Pharmaceuticals. In May, Kailera licensed exclusive rights to develop those molecules globally, except for greater China where Hengrui retains rights. The most advanced program is KAI-9531, a once-weekly injectable dual agonist of the GLP-1 and GIP receptors. Under Hengrui, Kailera said this drug showed “compelling results” in obesity and type 2 diabetes from Phase 2 tests conducted in China.
The Phase 2 test in obesity enrolled 249 participants randomly assigned one of four doses of the once-weekly injectable study drug or a placebo. The double-blind treatment period was 24 weeks. Hengrui presented Phase 2 results in obesity in June, during the American Diabetes Association Scientific Sessions meeting. These results showed a dose-dependent increase in weight loss during the treatment period. At the 6 mg dose — the highest one tested — 53.1% of patients lost 15% or more of their body weight compared to baseline. Adverse events reported from the study included nausea, diarrhea, decreased appetite, and vomiting. Gastrointestinal problems are consistent with other weight management drugs and Hengrui classified the side effects in its study as mild to moderate in severity.
It’s difficult to make cross-trial comparisons, but the results for the drug that is now Kailera’s lead program suggest it’s competitive with others targeting both GLP-1 and GIP. In Zepbound’s pivotal study, patients lost an average 18% of their body weight compared to those who received a placebo. In February, San Diego-based Viking Therapeutics reported Phase 2 data for its once-weekly injectable GLP-1 and GIP agonist, VK2735, showing an average 13.1% placebo-adjusted weight loss after 13 weeks of treatment. A larger and longer Phase 3 study is planned for this molecule. An oral version of the Viking drug is expected to begin a Phase 2 test in obesity by the end of this year.
Roche is going after GLP-1 and GIP with CT-388, an injectable peptide from its $2.7 billion acquisition of Carmot Therapeutics last year. In a Phase 1 test, Roche reported the average placebo-adjusted weight loss at 24 weeks was 18.8%. An oral drug included in that M&A deal posted encouraging Phase 1 data over the summer.
[Paragraph updated to clarify oral drug pipeline.] Kailera’s pipeline also includes oral therapies. The Hengrui deal brought the small molecule KAI7535 and an oral version of KAI-9531. Kailera’s fourth program is an injectable drug that goes after three targets: GLP-1, GIP, and glucagon receptor. New York-based Metsera has a program that also goes after those three targets. Its most advanced program hits only GLP-1, but with a dosing edge of an injection once a month. Last week, Metsera announced Phase 1 results showing 7.5% reduction in body weight measured at day 36. The company, which launched in April backed by $290 million, expects to begin a Phase 2b test of its lead program by the end of this year; preliminary data are expected in the first half of 2025.
Kailera’s Series A financing announced Tuesday was co-led by Atlas Venture, Bain Capital Life Sciences, and RTW Investments. Lyra Capital also participated in the round. The company is led by CEO Ron Renaud, who was most recently the chief executive of Cerevel Therapeutics, a neurological diseases drug developer recently acquired by AbbVie.
“In this period of rapid innovation in the metabolic space, I believe that Kailera is poised to make an impact beyond the current market leaders,” Renaud said in a prepared statement. “We have an incredible opportunity to develop next-generation treatments for chronic weight management, helping people reclaim their health and live their lives to the fullest.”
Photo: Jason Dean, Getty Images