A Hengrui Pharma obesity drug designed to hit two targets led to an average of nearly 18% weight loss in a pivotal study, paving the way for a regulatory submission in China, where the trial was conducted and the company is based. These results are also encouraging for biotech startup Kailera Therapeutics, which holds rights to develop and commercialize this drug candidate in the rest of the world.
Hengrui’s peptide drug, HRS9531, is engineered to bind to and activate the GLP-1 and GIP receptors — the same two targets hit by blockbuster Eli Lilly’s chronic weight management drug, Zepbound. Both drugs are administered as weekly injections, so Hengrui needs to show differentiation on efficacy and tolerability. The preliminary Phase 3 results reported Tuesday suggest Hengrui’s drug are competitive.
The Phase 3 trial enrolled 567 participants with an average weight at baseline of 93 kg (about 205 pounds). Patients were randomly assigned to receive one of three doses or a placebo administered weekly for 48 weeks. The preliminary results show 6 mg of HRS9531, the highest of the three doses tested, led to an average of 19.2% loss in body weight; 17.7% when adjusting for the placebo responses.
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Hengrui said up to 88% of participants who received its drug achieved at least 5% weight loss and 44.4% of participants achieved at least 20% weight loss. There was no plateau to this weight loss, indicating that continued dosing could lead participants to lose more.
Comparisons across clinical trials come with all sorts of caveats. For example, Lilly’s key test of Zepbound in obesity was larger and enrolled participants with a higher average starting weight. But results from this study showed the highest of three Zepbound doses led to 20.9% weight loss measured at week 72.
Gastrointestinal problems are common for these drugs that work by mimicking gut hormones. In clinical trials, these side effects have led participants to stop treatment. Hengrui did not disclose discontinuation rates in its study. On the assessments of safety and tolerability, the company only said its drug’s safety profile was consistent with other GLP-1 drugs. Hengrui said full Phase 3 results will be shared at an upcoming scientific conference. If the drug receives regulatory approval in China, it will compete head to head against Zepbound, which is already approved in the country.
“Based on these robust and encouraging clinical results, we are accelerating our efforts to advance this highly promising candidate,” Hong Chen, head of metabolism department I of Hengrui Pharma, said in a prepared statement. “We look forward to filing for market approval in China as soon as possible to bring HRS9531 to patients struggling with obesity and overweight.”
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HRS9531 was discovered and developed by Hengrui. Kailera, which maintains operations in San Diego and Waltham, Massachusetts, launched last fall revealing $400 million in financing and rights to Hengrui’s drug outside of greater China. Under Kailera, the Hengrui drug goes by the code name KAI-9531. In the joint Hengrui and Kailera announcement, Kailera CEO Ron Renaud said his company’s global clinical development program for the drug will evaluate higher doses and longer duration of treatment.
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