Hengrui Pharma's potential rival El Lilly's Zepbough results in 18% weight loss in key study
The Hengrui Pharma obesity drug aimed at achieving two goals, resulting in an average weight loss of nearly 18% in a pivotal study, paving the way for regulatory submissions that conducted trials in China, which was based on the company. These results are also encouraging for biotech startup Kailera Therapeutics, which has the right to develop and commercialize the drug in other parts of the world.
Hengrui's peptide drug HRS9531 is designed to bind to and activate GLP-1 and GIP receptors – the same as the two targets hit by Blockbuster Eli Lilly's long-term weight management drug Zepbound. Both drugs are used as weekly injections, so Hengrui needs to show differentiation of efficacy and tolerance. Preliminary Phase 3 results reported Tuesday that Hengrui's drug is competitive.
The third phase of the trial recruited 567 participants with an average weight of 93 kg (about 205 pounds). Patients were randomly assigned to receive three doses or one of the placebos taken weekly for 48 weeks. Preliminary results show that 6 mg of HRS9531 is the highest of the three doses tested, resulting in an average weight loss of 19.2%. When adjusting for placebo response, 17.7%.
Hengrui said that as many as 88% of participants who received the drug lost at least 5% of their weight, while 44.4% achieved at least 20% of their weight loss. This weight loss did not stabilize, suggesting that continuing administration may result in more losses in participants.
Comparisons conducted in clinical trials are related to various warnings. For example, Lilly tested Zepbough with a larger key test in obesity and the average starting weight of the participants was higher. But the results of this study showed that in the three zepbound doses at week 72, the weight loss was 20.9%.
Gastrointestinal problems are common for these drugs that work by mimicking the intestinal hormones. In clinical trials, these side effects caused participants to stop treatment. Hengrui did not disclose the shutdown rate in his study. In assessing safety and tolerance, the company only stated that the safety of its drugs is consistent with other GLP-1 drugs. Hengrui said the full-stage results will be shared at the upcoming scientific conference. If the drug is approved by regulators in China, it will compete with Zepbough, which has been approved in the country.
“Based on these powerful and encouraging clinical results, we are accelerating our efforts to promote this highly promising candidate,” said Hong Chen, head of the metabolic department of Hengrui Pharma I, in a prepared statement. “We look forward to applying for market approval in China as soon as possible to bring HRS9531 to obese and overweight patients.”
HRS9531 was discovered and developed by Hengrui. Kailera, which maintained operations in San Diego and Waltham, Massachusetts, launched $400 million in financing and Hengrui's rights to drugs outside of Greater China last fall. Under Kailera, Hengrui's drug is the code name of ki-9531. Kailera CEO Ron Renaud said in a joint announcement between Hengrui and Kailera that his company’s global clinical development program will evaluate higher doses and longer treatments.
Photo: Peter Dazeley, Getty Images
