Shares of Alumis (ALMS) fell approximately 2% on Tuesday after the company reported that its Phase IIb LUMUS trial of envudicitinib in systemic lupus erythematosus (SLE) failed to meet its primary and key secondary endpoints in the overall patient population.
At the Wells Fargo 21st Annual Healthcare Conference, CEO Martin Babler and CSO Jörn Drappa outlined how the results have reshaped the company's clinical strategy. Drappa said that while the overall trial missed its endpoints, patients testing positive for a type 1 interferon signature showed robust and consistent responses across multiple measures — including BICLA, SRI-4, CLASI skin scores, joint counts, and remission/LLDAS criteria. BICLA improved by roughly 30 percentage points versus placebo in that biomarker-positive group. In contrast, the interferon-signature-negative cohort showed no benefit, with active treatment sometimes appearing worse than placebo due to an unusually high placebo response rate.
Alumis had anticipated an 80/20 split between interferon-signature-positive and -negative patients, but the LUMUS trial enrolled approximately 60% positive and 40% negative. The one-year dose-ranging study tested three doses of envudicitinib against placebo in moderate-to-severe SLE patients, with the primary BICLA endpoint assessed at week 48.
In a separate strategic shift, Babler confirmed that Alumis has moved its brain-penetrant TYK2 inhibitor A-005 away from multiple sclerosis and into Parkinson's disease. The decision followed identification of a proprietary biomarker linked to Parkinson's pathology and additional market assessment. "We were ready to move with MS, but then based on some new information and additional market assessment, realized that the possibility to create significant value in the short to medium term on MS was a lot harder," Babler said. Toxicology work for the Parkinson's indication is complete, and healthy-volunteer formulation studies are underway. A new clinical molecule is expected to enter the clinic in 2025.
On the psoriasis front, Alumis plans to file an NDA by the end of 2024 for envudicitinib in a growing oral-market segment. Babler pointed to Johnson & Johnson's July launch data for anifrolumab as evidence that the market is expanding as anticipated, saying Alumis enters with a "very strong, highly competitive drug."
Alumis currently carries a market capitalization of approximately $1.44 billion. Shares are up roughly 157% over the past year, having traded between $3.76 and $31.35 over the 52-week period. The company holds a current ratio of 6.74 and has burned through roughly $352 million in levered free cash flow over the trailing twelve months. An FDA meeting was previously targeted for late 2024 or early 2025.
