A once-a-day, low-impact oral GLP-1 pill known as CX11 has passed its efficacy test on US patients to advance to the first North American Phase 3 trial. It’s already cleared its first Phase 3 study in China.
CX11, a small molecule GLP-1 receptor agonist (GLP-1 RA) from biopharmaceutical company Corxel, was administered to US patients with obesity or excess weight over the course of 36 weeks.
The trial, featuring 246 adults with at least one comorbidity, was randomized 1:1:1:1:1, with people receiving either CX11 120 mg, CX11 160 mg, CX11 200 mg (slow titration), CX11 200 mg (fast titration), or a placebo each day for those 36 weeks.
After the trial, the patients who received CX11 had lost up to 11.5% of their body weight. What’s more, the weight loss was steady but persistent throughout the lengthy study, with no signs of plateaus or a tapering off of the drug’s efficacy by week 36.
CX11 also had good tolerability as it passed through the gastrointestinal tract, with a very low rate of adverse reactions like vomiting. Just 12-16% across the dosing cohorts reported vomiting, which is around half the number that existing injected medications like Wegovy report (nearly 25%).
For those who experienced nausea, vomiting, diarrhea, or constipation, there were no severe cases, and most were transient, disappearing once the patient adjusted to the medication. Further testing found no evidence of any dose having a negative impact on the liver.
There was also a very small discontinuation rate (5%).
“We are delighted with these positive US Phase 2 results, which are consistent with the competitive profile established in the China Phase 3 program,” says Bo Liang, MD, Chief Medical Officer of Corxel.
“Together, these datasets reinforce our confidence in CX11 and our conviction to offer patients around the world an effective and highly tolerable option with dosing flexibility,” he adds. “As we look forward to advancing into pivotal global Phase 3 studies for CX11, we are also enthusiastic about the potential of our other cardiometabolic programs in development, including CX12, our internally discovered small molecule amylin RA product.”
CX12 is currently at the pre-clinical stage in the company’s pipeline.
While patients have an increasing number of options when it comes to GLP-1 RAs, the first wave of these medications has not been one-size-fits-all. Specific manufacturing conditions, cold storage, supply chain issues, and cost have been a few of the challenges.
An oral pill that can be taken with or without food, that doesn’t require refrigeration – while delivering comparable weight loss to injectables without the same degree of adverse effects – is a winning formula on paper.
The results of the drug’s first Phase 3 trial, which enrolled 840 obese or overweight Chinese adults, were released earlier this year.
At 52 weeks, CX11 – or VCT220 as it’s known on the mainland – the participants in the 120 mg and 160 mg cohorts experienced a mean body weight reduction of -12.2% and -12.4%, respectively.
Vincentage Pharma – which has the rights to the drug in China – is said to be in the process of applying for its domestic release, where it will challenge Eli Lilly’s orforglipron (Foundayo) for oral GLP-1 RA market share.
While an obesity-focused Phase 3 trial in the US is needed before CX11 can be submitted to the US Food and Drug Administration (FDA) for approval, its imminent Chinese market release has it well positioned to compete with Lily’s oral pill Stateside in the not-too-distant future.
Foundayo – a CX11-adjacent pill that can be taken at any time of the day without food or water restrictions – was approved by the FDA in April.
Source: Corxel
Fact-checked by Mike McRae
