Innovent's Tepezza rival one step closer to Chinese approval after phase 3 eye disease win

Innovent Biologics is hoping that a phase 3 win for its thyroid eye disease (TED) treatment will provide a first shot at the Chinese equivalent of a market that has already been conquered by Amgen’s Tepezza in the U.S.

Like Tepezza, Innovent’s candidate IBI311 targets the insulin-like growth factor 1 receptor (IGF-1R). The candidate hit the primary endpoint of the phase 3 Restore-1 trial by showing a greater reduction in eyeball protrusion—known as proptosis—than placebo.

The percentage of subjects with a reduction in proptosis of 2 mm or more in one eye without the equivalent increase in proptosis in the other eye was 85.8% among the IBI311 group, compared with just 3.8% among those who received placebo. The candidate also showed “significant” improvement on key secondary endpoints for the trial, including overall response rate, percentage of subjects with a clinical activity score of 0 or 1, and mean change in proptosis from baseline, Innovent said in a Feb. 20 release.

No serious adverse events occurred, added the biotech, which plans to release detailed results from the study at future medical conferences or in journals.

Lei Qian, vice president of clinical development at Innovent, said the company plans to submit a new drug application to Chinese regulators “as soon as possible” based on the results.

TED occurs in 16 out of every 100,000 women and 2.9 in every 100,000 men, according to Innovent. The condition is clearly a tempting target, with Horizon Pharma’s Tepezza quickly securing blockbuster sales. Horizon noticed a drop off in uptake in the drug’s third year on the market, with Amgen making this a top priority when it acquired the biotech in October 2023.

Still, as the only approved treatment for TED in the U.S., Tepezza garnered sales of $1.66 billion in its first full year on the market and $1.97 billion in 2022 before stalling out.

Amgen also sees an international opportunity for Tepezza. The drug is under review in Japan and the company will file this year for approval in Europe. A subcutaneous version of the treatment is also in development.

"There are no targeted drugs approved in the field of TED in China so far, while the treatment costs of overseas targeted drugs are beyond many patients' reach,” Qian explained in Innovent’s release this morning.

The clinical success of IBI311’s comes a month after mazdutide, a GLP-1/glucagon receptor agonist that Innovent licensed from Eli Lilly, demonstrated weight loss abilities in a phase 3 trial. Qian aligned these recent wins with the Chinese approval of its hypercholesterolemia injection Sintbilo in August 2023 as proof of the strength of Innovent’s late-stage strategy.

“With the approval of Sintbilo, the NDA acceptance of mazdutide and the endpoints met in phase 3 study of IBI311, Innovent is strategically establishing its innovative commercial and late-stage portfolio in the fields of cardiovascular and metabolic diseases, endocrinology and ophthalmology,” Qian added.

Innovent isn’t the only biotech looking to stake out a piece of TED territory. Last month, Kriya Therapeutics announced plans to get a gene therapy into the clinic for the condition next year, while Lassen Therapeutics has already dosed the first patient in a phase 1 trial of an interleukin-11 receptor targeted at TED.