Kailera Biotech Launches with $400M for Advanced Weight-Loss Drugs

Eli Lilly's successful development of a dual-target metabolic drug for obesity has set a high standard in the industry, prompting other companies to develop similar approaches. Kailera Therapeutics is the latest to enter this competitive field, having secured $400 million to build a pipeline of obesity treatments. Operating from San Diego, California, and Waltham, Massachusetts, Kailera focuses on creating drugs that emulate natural peptides, activating bodily receptors to induce metabolic changes.

Kailera's lead program targets GLP-1 and GIP receptors, the same metabolic targets addressed by Eli Lilly’s Zepbound, a drug approved by the FDA for long-term weight management in November last year. Kailera’s portfolio, comprising four drugs for metabolic disorders, was acquired from Jiangsu Hengrui Pharmaceuticals, a China-based company. In May, Kailera obtained exclusive global rights to these molecules, excluding greater China where Hengrui retains rights. The foremost candidate, KAI-9531, is a once-weekly injectable that acts on both GLP-1 and GIP receptors. Phase 2 trials in China under Hengrui revealed promising results for this drug in treating obesity and type 2 diabetes.

The Phase 2 obesity study included 249 participants who were randomly assigned one of four doses of the injectable drug or a placebo over a 24-week double-blind period. Results, presented at the American Diabetes Association Scientific Sessions in June, demonstrated a dose-dependent increase in weight loss. At the highest dose of 6 mg, 53.1% of participants lost 15% or more of their body weight compared to baseline. Adverse effects reported included nausea, diarrhea, decreased appetite, and vomiting. These gastrointestinal issues were classified as mild to moderate, aligning with typical side effects of weight management drugs.

While it’s challenging to directly compare results across different clinical trials, Kailera's lead program appears competitive with other dual-target drugs. For instance, Zepbound’s pivotal study showed an average 18% weight loss in patients compared to a placebo group. Viking Therapeutics, based in San Diego, reported a 13.1% placebo-adjusted weight loss after 13 weeks of treatment with its once-weekly GLP-1 and GIP agonist VK2735. Viking plans a larger Phase 3 study and an oral version of their drug to begin Phase 2 testing by the year’s end.

Roche is also targeting GLP-1 and GIP with CT-388, an injectable peptide from its $2.7 billion acquisition of Carmot Therapeutics. Phase 1 results revealed an 18.8% placebo-adjusted weight loss at 24 weeks. Additionally, an oral drug from the same acquisition showed promising Phase 1 results during the summer.

Besides injectables, Kailera’s pipeline includes oral therapies. The deal with Hengrui brought in two small molecule programs, KAI-7535 and KAI-9531. Kailera’s fourth offering is an injectable drug targeting GLP-1, GIP, and the glucagon receptor. Metsera, based in New York, is developing a similar program. Metsera’s advanced drug hits only GLP-1 but offers the advantage of a monthly injection. Recently, Metsera announced Phase 1 results showing a 7.5% reduction in body weight by day 36 and plans to start a Phase 2b trial by the end of the year, with preliminary data expected in the first half of 2025.

Kailera’s Series A funding round, announced on Tuesday, was co-led by Atlas Venture, Bain Capital Life Sciences, and RTW Investments, with participation from Lyra Capital. The company is led by CEO Ron Renaud, formerly the chief executive of Cerevel Therapeutics. Renaud expressed optimism about Kailera’s potential to surpass current market leaders in metabolic treatments, aiming to develop next-generation therapies for chronic weight management and significantly improve patients' quality of life.