Kailera, Hengrui stake claim to oral weight loss category

Hengrui Pharma and partner Kailera have joined the ranks of companies with clinical data in hand for an oral drug for weight loss, reporting weight loss of up to 12.1% in a phase 2 trial with their ribupatide candidate.

Dual GIP and GLP-1 agonist ribupatide (KAI9531) is already in phase 3 testing as a once-weekly injectable for obesity, having produced an impressive weight loss of 23.6% in its phase 2 programme.

The oral version was never likely to achieve that level of efficacy, and the 12.1% reduction seems to be in the same ballpark as the weight loss seen with Novo Nordisk's recently launched oral version of Wegovy (semaglutide) and Eli Lilly's orforglipron, which is currently under regulatory review in the US.

That said, both Wegovy and orforglipron target GLP-1 alone, so there had been an expectation that ribupatide's dual mechanism may deliver more potent results.

The data is still early, however, and Kailera and Hengrui have said that the 12.1% weight loss at 26 weeks was achieved with no sign of a plateauing in effect, while nearly 39% of subjects in the phase 2 trial achieved at least a 15% reduction.

The study, which is being conducted in 166 Chinese adults living with obesity, also showed a reasonably benign side-effect profile with ribupatide, with vomiting – a common complaint with incretin-based weight-loss therapies – reported in 11.4% and 7.5% of participants taking 25 mg and 50 mg doses of the drug, respectively.

Nausea was seen in more than one in five patients at those dose levels, but there were no permanent treatment discontinuations or down-titrations due to gastrointestinal side effects, said the two companies

Armed with the new data, Hengrui has said it will press ahead swiftly with a phase 3 programme for the drug in China, while Kailera is planning a phase 2 international trial this year.

Kailera licensed ribupatide along with other incretin candidates for $110 million upfront in 2024. Its other programmes include a small-molecule GLP-1 agonist, KAI7535, which has also shown efficacy in a Chinese phase 2 study.

The US company's chief medical officer, Scott Wassermann, said the phase 2 data with oral ribupatide are an "important milestone" in the company's efforts to build a franchise around the drug.

"We believe oral ribupatide could help to address the diverse needs of people living with obesity or overweight and meet patients wherever they are in their treatment journey," he added.

"These positive data suggest a potentially game-changing clinical profile for an oral obesity therapy."

Earlier today, another company seeking to break into the oral weight-loss category, AstraZeneca, reported top-line phase 2b results with its oral GLP-1 drug elecoglipron.

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