Kailera secures $600M in funding to advance dual-targeted obesity drug into global Phase 3 testing
Kailera Therapeutics executives say their lead drug candidate could become the best drug in an obesity drug class currently dominated by Eli Lilly and Co.'s blockbuster product, and the biotech has raised $600 million for a Phase 3 clinical trial to prove it.
The Series A round announced Tuesday comes nearly a year after Kailera, based in Waltham, Mass., and San Diego, emerged with four metabolic disorder drug candidates licensed from Jiangsu Hengrui Pharmaceuticals. The most advanced of these, KAI-9531, is a modified peptide that activates GLP-1 and GIP receptors—the same goal Eli Lilly's obesity drug Zepbound achieves.
China's Hengrui retains the rights to KAI-9531 in its home country, where the drug's development code is HRS9531. In July, Kailera and Hengrui reported preliminary results from a Phase 3 trial in China showing that patients who received the drug once-weekly injections lost an average of 19.2% in weight compared with placebo. These results were for the 6 mg dose, the highest of the three doses tested. Weight loss measured at 48 weeks did not plateau, suggesting that patients lost more weight as they continued taking the drug.
China's Phase 3 program did not disclose data on drug discontinuation, which is important because gastrointestinal side effects are one of the main reasons patients stop taking obesity drugs. The companies said only that emergent adverse events from the gastrointestinal treatment in the study were mild to moderate and consistent with the drug's safety and tolerability profile in Phase 2 testing.
Due to differences in clinical trial design and patient populations, cross-trial comparisons require attention. Zepbound's Phase 3 trial enrolled obese and overweight patients but without type 2 diabetes, and those who received the high 15 mg dose achieved an average placebo-adjusted weight loss of 17.8% measured at 72 weeks. In studies evaluating the drug in people with type 2 diabetes, results showed a placebo-adjusted mean weight loss of 11.6% at 72 weeks. The discontinuation rate at the high dose in both studies was 6.7%; most discontinuations occurred within the first few months of treatment due to gastrointestinal side effects.
For KAI-9531, Kailera plans to conduct two global Phase 3 studies enrolling obese or overweight adults with and without type 2 diabetes. The company also plans to conduct a third study enrolling adults with a body mass index of 35 or higher. A BMI of 30 or higher is considered the baseline for obesity. Kailera plans to begin these studies by the end of this year.
“With the global population affected by obesity increasing and those with higher body mass index having limited options, the need for effective treatment options has never been greater,” Kailera President and CEO Ron Renaud said in a prepared statement. “With this funding, we will accelerate the progress of our pipeline, including our lead program, KAI-9531, which has the potential to deliver significant weight loss for patients with obesity.”
Kailera's new Series B funding will also support global clinical testing of KAI-7535, an oral small molecule GLP-1 receptor agonist in mid-stage development for obesity and type 2 diabetes. In addition, the funds will support other projects authorized by Hengrui. KAI-4729 is an injectable drug designed to activate three targets (GLP-1, GIP, and glucagon receptors) and is currently in early clinical development to treat obesity and type 2 diabetes. KAI-9531 is an orally available small molecule designed to activate GLP-1 and GIP receptors and is currently in mid-stage clinical development for the treatment of obesity and type 2 diabetes. Kailera said that in addition to its current product line, it also has certain rights to license new formulations of the product, as well as rights of first refusal on select assets within Hengrui's metabolic disease portfolio.
Metabolic disorder drugs remain popular targets for deals. Last month, Pfizer agreed to pay $4.9 billion to acquire Metsera, a clinical-stage biotech developing obesity drugs that can be injected monthly or over longer periods of time. Last week, Novo Nordisk acquired Akero Therapeutics, whose lead drug candidate has the potential to treat patients with the most severe stages of fatty liver disease MASH, for $4.7 billion.
Kailera's latest funding round was led by new investor Bain Capital Private Equity. Other new investors include Adage Capital Management LP, Canada Pension Plan Investment Board, Invus, Janus Henderson Investors, Perseverance Capital, Qatar Investment Authority (QIA), Royalty Pharma, Surveyor Capital (a Citadel company), accounts advised by T. Rowe Price Associates, Inc. and an undisclosed large mutual fund. Kailera's early investors Atlas Venture, Bain Capital Life Sciences, RTW Investments and Sirona Capital also participated in the Series B round.
Photo: Peter Dazeley, Getty Images
