Alumis’ TYK2 drug fails in key lupus study

An article from Dive Brief Alumis’ TYK2 drug fails in key lupus study Though Alumis still sees a path forward in lupus, the result made its drug the latest TYK2 blocker to struggle in conditions beyond psoriasis and psoriatic arthritis. Published Sept. 1, 2026 Gwendolyn Wu Senior Reporter Share Copy link Email LinkedIn X/Twitter Facebook Print License Add us on Google Dive Brief: An experimental drug Alumis has been testing in a form of lupus failed a mid-stage study, but the company will press forward after observing positive signs in a subgroup of trial participants.

According to Alumis, the drug, envudeucitinib, missed all of its main and secondary objectives in systemic lupus erythematosus. Still, “robust” responses were seen in trial volunteers with “high interferon gene signature,” meaning certain genes controlled by interferons are overexpressed. A majority of people with moderate-to-severe SLE fit this description, Alumis said.

Alumis will meet with regulators to discuss a path toward a Phase 3 trial. Company shares plummeted by nearly 55% on the results, though, nearly erasing all of Alumis’ stock gains this year. The company's market value had soared following positive results in psoriasis in January.

Dive Insight: Envudeucitinib is part of a popular class of medicines known as TYK2 inhibitors, which are seen as potentially powerful oral alternatives to the injectable treatments often used to treat autoimmune conditions. Bristol Myers Squibb brought the first of these medicines, Sotyktu, to market in psoriasis and psoriatic arthritis. But Sotyktu hasn’t yet sold as well as the company hoped, and drugmakers following in Bristol Myers footsteps are hoping newer TYK2 blockers might be more impactful.

Both Alumis and Takeda Pharmaceuticals — which spent $4 billion on a TYK2 blocker from Nimbus Therapeutics — have shown that these next-generation versions might be more potent against psoriasis. But they haven’t yet proven that TYK2 blockers can be useful elsewhere. There’s skepticism to overcome, too, as multiple other TYK2 inhibitors have struggled against lupus and inflammatory bowel disease.

In its study, Alumis enrolled 408 lupus patients and tested three different doses of envudeucitinib against a placebo over 48 weeks. Envudeucitinib missed statistical significance on a few different assessments of disease activity and treatment responses. But the drug was still well-tolerated and was associated with fewer adverse events than a placebo, Alumis’ Chief Medical Officer Jörn Drappa said on a conference call.

However, envudeucitinib’s impact on people with a high interferon gene signature was similar to what was observed in testing of Sotyktu and makes continued development in lupus worth pursuing, Alumis said. Still, the results were “disappointing,” wrote Leerink Partners analyst Thomas Smith. And though trials in lupus have been “notoriously challenging,” use of TYK2 blockers outside of psoriasis and psoriatic arthritis is “likely to be viewed as a show-me story,” Stifel analyst Alex Thompson added, in a separate note.

Alumis still intends to file for U.S. approval of envudeucitinib in psoriasis by the end of 2026. “We do not foresee significant changes to our overall development timeline,” Martin Babler, Alumis’ CEO, said on Tuesday’s call.

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