Kailera Therapeutics’ bet on Hengui Pharma’s oral glucagon-like peptide 1 receptor agonist (GLP-1RA) appears to be paying off following two late-stage wins in obesity and type 2 diabetes (T2D) – teeing it up for approval in China, and potentially poising it to become a Foundayo (orforglipron) market rival.
The small molecule weight loss pill, HRS-7535, met its primary endpoint in both the Phase III HARBOR-1 (NCT06904105) and OUTSTAND-2 (NCT06589765) trials conducted by Hengrui in China, which enrolled adults with obesity and T2D, respectively.
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In HARBOR-1, HRS-7535 offered weight loss from baseline of 10.9% at the high 180mg dose by week 44 based on the efficacy estimand – besting the 2.5% rate observed in patients taking the placebo. This effect appears to have grown through to the end of the trial, as an ad hoc analysis demonstrated that, at week 50, patients given a high dose of the drug achieved 11.1% weight loss from baseline.
However, gastrointestinal treatment-emergent adverse events (TEAEs) were significant among patients in both the low- and high-dose HRS-7535 groups, with around 70% experiencing nausea compared to 16.2% in placebo, and between 66 and 68% enduring vomiting during treatment versus 4.5% for placebo-treated patients. This translated into TEAE-linked discontinuations in 4.1%, 3.1% and 2.7% of patients in the 120mg, 180mg and placebo arms.
Kailera and Hengrui secure Chinese T2D win
Alongside the generally positive results of the HARBOR-1 trial, HRS-7535 also posted success in the Phase II OUTSTAND-2 trial, which pitted the drug against AstraZeneca and Bristol Myers Squibb’s glucose reabsorption blocker, Farixga (dapagliflozin), in patients with T2D that remains uncontrolled despite treatment with metformin therapy.
In the study, researchers found that HRS-7535 was non-inferior to Farixga at the 30, 60 and 90mg dose levels at week 32 – triggering a significant 1.68% reduction in the key diabetes biomarker, HbA1c, at the highest dose, compared with the 1.28% drop achieved by the rival drug.
Patients given HRS-7535 also experienced improvements in body weight, blood pressure and lipid profiles, while experiencing no low blood sugar events listed as Grade 3 or worse, and no treatment-linked liver issues.
Taking on the competitive obesity market
This double win will be welcome news for Kailera, which originally acquired the rights to HRS-7535, or KAI-7535, outside of China from Hengrui in 2024. Since then, the company has initiated a global Phase II study (NCT07497880) exploring the oral GLP-1RA’s potential for treating obesity and T2D.
To fund this programme, as well as the late-stage development of its lead candidate, ribupatide, Kailera recently debuted on the Nasdaq exchange – raising $625m in one of the largest biotech IPOs in history.
Now, the biotech is hoping to compete with obesity stalwarts, Eli Lilly and Novo Nordisk, which both have their own oral weight loss offerings in the form of Foundayo (orforglipron) and oral Wegovy (semaglutide) – which are currently battling it out for market share as prescriptions rise.
As the obesity space rapidly evolves away from its focus on weight loss alone, experts previously told Pharmaceutical Technology, sister publication of Clinical Trials Arena, that improving safety, preserving lean muscle mass and better addressing obesity’s linked comorbidities could represent the next frontier or the weight loss market – presenting developers an opportunity to grab and hold onto market share in this increasingly crowded segment.
However, across England, inequalities in obesity persist despite efforts spanning the last half a decade, say GlobalData analysts.
GlobalData is the parent company of Clinical Trials Arena.
