Five months after Corxel Pharmaceuticals reeled in hundreds of millions of dollars to support further development of its oral GLP-1 drug prospect, the company now has more reason to put the money to work.
Tuesday, Corxel revealed that its small molecule GLP-1 drug, CX11, was associated with weight loss of up to 11.5% in a U.S. phase 2 trial of adults with obesity or who were overweight with at least one comorbidity.
The study enrolled 246 participants and tested four different dosing approaches with the oral GLP-1 alongside placebo. The trial met its primary endpoints assessing weight loss from baseline versus placebo.
At 36 weeks, the drug showed weight loss of up to 11.5%, Corxel said in a June 23 release, with “no evidence of a slowing trajectory.”
The biotech further touted the tolerability and safety profile seen in the study, with CX11 nausea rates ranging from 33-34%, vomiting from 12-16%, diarrhea from 4-12% and constipation from 2-12%. The biotech reported no severe cases of any of these side effects. Overall, the discontinuation rate from gastrointestinal adverse events was 5%, and the company said there was “no hepatic safety signal observed.”
Corxel licensed the ex-China rights to the drug from Vincentage in late 2024. Just last month, Vincentage touted weight loss of 12.4% over a year seen in a China phase 3 study, setting that company up for a regulatory push in its home country.
In a Tuesday statement, Corxel Chief Medical Officer Bo Liang, M.D., Ph.D., said the U.S. phase 2 results are “consistent with the competitive profile established in the China Phase 3 program.”
“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,” Liang added.
Now, Corxel is gearing up to put its series D cash to work. With the China phase 3 and U.S. phase 2 results in hand, the biotech is planning to advance the candidate into pivotal global phase 3 studies for weight management.
As Corxel ushers its asset into the next phase of development, the biotech is undoubtedly keeping an eye on the rest of the oral GLP-1 landscape. Earlier this month, AstraZeneca reported average weight loss of 10.5% after 26 weeks in a phase 2b trial of its oral small molecule GLP-1 receptor agonist dubbed elecoglipron. Like Corxel, AZ is pushing the drug ahead into late-stage development after seeing the data.
Elsewhere, Structure Therapeutics’ aleniglipron has been associated with weight loss of up to 15.3% from baseline after 44 weeks, which CEO Raymond Stevens, Ph.D., described as the “highest weight loss observed for an oral GLP-1RA to date.” That company is also prepping its own phase 3 push.
The companies are all chasing Eli Lilly and Novo Nordisk with their marketed offerings, while further back in development are candidates from Ambrosia and BrightGene, among others.