California-based biopharma company Alumis is taking its immunology candidate, envudeucitinib, to Phase III in a type of lupus, despite the drug missing its goals across the general population in a Phase IIb trial.
During the mid-stage LUMUS study (NCT05966480), Alumis pitted three different doses of envudeucitinib against placebo in 408 adult patients with systemic lupus erythematosus (SLE) over a 48-week period. The trial set out to measure if the oral tyrosine kinase 2 (TYK2) inhibitor would have any impact on overall disease activity, while reducing patient steroid use and maintaining safety and tolerability.
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In this study, envudeucitinib failed to meet both its primary and secondary endpoints, as the drug did not have a significant effect on global or skin-related disease activity across the general study population.
However, envudeucitinib did have an impact on a subset of patients with high interferon gene signatures, noted Alumis’ CMO, Dr Jörn Drappa, who added that the magnitude of effect within this group was “highly compelling”. According to a paper published in Curr Opin Immunol, around half of the SLE patient population have chronically elevated type 1 interferon levels.
Now, with mixed results in hand, Alumis plans to soldier on with the drug’s development in SLE. Envudeucitinib was proven to be safe and tolerable, with no new safety signals observed.
If envudeucitinib were to secure approval in SLE, it could become one of the first oral targeted therapies to reach a market GlobalData projects will be worth $5.9bn across the seven major markets in 2034 (7MM: US, France, Germany, Italy, Spain, UK, and Japan).
Executives tout envudeucitinib’s potential despite Phase IIb miss
While envudeucitinib’s miss within the general SLE population will be disappointing news for Alumis, the company’s CEO, Martin Babler, believes there could also be a notable opportunity for the drug in conditions like cutaneous lupus erythematosus (CLE) and Sjögren’s disease due to the drug’s positive data in patients with high interferon gene signatures.
However, investors do not appear to be enamoured with the drug’s potential, as Alumis’ stock value plunged 56% after the results debuted, from $21.81 at market close on 31 August to $9.47 at the same time on 1 September.
Now, Alumis will look ahead to initiating its Phase III study on envudeucitinib in SLE by convening with regulators to discuss development. The biopharma will also continue to work on its New Drug Application (NDA) for envudeucitinib in moderate-to-severe plaque psoriasis – which it hopes to submit in the final quarter of 2026 after the drug secured a Phase III win back in January 2026.
