$600m round will help Kailera push obesity drug into phase 3
Ron Renaud, president and chief executive of Kailera.
Kailera Therapeutics has raised an eye-watering $600 million in Series B financing to take its lead drug for weight loss into pivotal trials, in a further sign of the insatiable investor appetite for obesity-related stocks.
The US start-up is developing dual GLP-1 and GIP agonist KAI-9531 in partnership with China's Hengrui Pharma, and has said it intends to start phase 3 trials of the obesity candidate before the end of this year. In China, where the drug is known as HRS9531, is already being prepared for a regulatory filing.
The once-weekly injectable has a similar mechanism of action to Eli Lilly's Zepbound (tirzepatide), which made nearly $5.7 billion in sales in the first half of the year, but according to Kailera could deliver "potentially best-in-class weight loss."
Zepbound is growing fast on the back of data showing it is more effective at reducing weight than its main rival in the obesity category, Novo Nordisk's GLP-1 agonist Wegovy (semaglutide), but there are dozens of new weight-loss candidates coming through the pipeline with a mission to supplant the two market leaders.
Kailera has said it plans to evaluate both higher doses and longer duration of treatment in global clinical trials as it contemplates taking on Novo Nordisk and Lilly in the obesity market.
The Series B was led by new investor Bain Capital, with buy-in from a lengthy list of new and existing investors, and comes just over a year after Kailera burst onto the scene with a $400 million first round.
In a statement, Kailera said it recently completed end-of-phase 2 meetings with the FDA and is now planning two phase 3 trials of KAI-9531 in adults living with obesity or overweight with comorbidities, with and without type 2 diabetes, as well as an additional study in very obese individuals living with a body mass index (BMI) of 35 or higher.
The new funding will also go towards a follow-up obesity programme, small-molecule GLP-1 agonist KAI-7535, which has shown efficacy in a Chinese phase 2 study. Lilly and Novo Nordisk are also trying to bring oral weight-loss drugs to market and have reported positive phase 3 results with their respective candidates in the last few weeks.
"We are excited to welcome our new investors and extend sincere appreciation to our current investors for their continued confidence in our vision," said Ron Renaud, president and chief executive of Kailera.
"With an increasing global population affected by obesity and limited options for those living with higher BMIs, the need for effective treatment options has never been greater."
Kailera has become closely watched in the weight-loss category as a potential buyout candidate, given that it already has a phase 3-ready candidate and follow-up options. Last month, Pfizer reached a deal to buy another company in that mould, Metsera, in a $4.9 billion deal.
