Alumis (NASDAQ:ALMS) executives highlighted recent clinical progress for the company’s TYK2 inhibitor programs and previewed multiple upcoming catalysts during remarks at the Leerink Partners Global Healthcare Conference. CEO Martin Babler and CFO John Schroer discussed phase III psoriasis results for envudeucitinib, the company’s plans for regulatory filing, a pending phase IIb lupus readout, and development strategy for a broader TYK2 “franchise” that also includes a brain-penetrant compound, A-005.
Psoriasis phase III: top-line efficacy and upcoming AAD details
Babler described Alumis as a “precision immunology company” that originated from genomic work that pointed to TYK2 as a meaningful target in immunology. He said Alumis’ thesis has been that stronger TYK2 inhibition should translate into better clinical outcomes than “first-generation TYK2 inhibitors,” referencing genetic observations that individuals with TYK2 mutations that down-regulate kinase function can show stronger protective effects than heterozygous carriers.
Babler also said Alumis has quality-of-life and itch data from the studies that have not yet been disclosed and are expected to be presented at the American Academy of Dermatology (AAD) meeting. He noted that AAD’s website lists a late-breaking presentation involving envudeucitinib.
Safety and the “more inhibition” thesis
On safety, Babler said envudeucitinib’s phase III safety profile was “very consistent” with the company’s phase II experience, including longer-term extension data. He acknowledged that event counts can be higher in a six-month dataset than in a 12-week dataset, but maintained that safety was consistent across the trials Alumis has conducted.
Addressing whether higher TYK2 inhibition could worsen tolerability, Babler argued that genomics suggest TYK2 downregulation does not produce a notable phenotype, and he emphasized that selectivity across the broader kinome may contribute to safety outcomes. He also said Alumis was the only TYK2 program that did not have to dose-reduce from phase I into later-stage studies due to safety issues, and he said that has “borne out” through phase III so far.
Regulatory timeline and what the filing will include
Babler said Alumis plans to submit a New Drug Application in the second half of this year. He explained that the phase III program includes a withdrawal component intended to support durability and maintenance claims, and that the “complete data set” for that work is expected by the end of the second quarter or early third quarter.
He said the submission package is expected to include:
- Phase III efficacy data, including the withdrawal portion
- Safety data
Babler also noted that Alumis has a phase II extension such that, by the time of launch, the company expects to have three-year safety data, which he said it hopes to include in labeling.
Commercial strategy: scaling vs. partnering and a broader TYK2 franchise
When asked about launch planning and whether Alumis might commercialize alone or partner, Babler said the company has internal capabilities to prepare for launch activities now, but framed the decision primarily around the broader opportunity of building a TYK2 franchise spanning roughly 20 potential indications. He said the probability of Alumis developing and launching around 20 TYK2 indications globally as a single company is “extremely slim,” making partnering considerations central. He said the company is weighing whether to wait for lupus data before engaging in broader partnering discussions.
Lupus phase IIb: rationale and trial design choices
Babler said Alumis is “really excited” about lupus for envudeucitinib, citing three main reasons: genomic support that he said resembles psoriasis; data from deucravacitinib showing clinically meaningful and statistically significant responses across doses in lupus; and validation of the interferon pathway via anifrolumab, which he described as one of only two approved lupus drugs.
He detailed several design elements intended to address lupus trial challenges, including placebo response in a waxing-and-waning disease. Babler said Alumis enriched enrollment for systemic lupus erythematosus (SLE) patients with a skin component, chose BICLA as an endpoint to better measure skin manifestations, and implemented an adjudication panel to confirm active disease at randomization and first dosing. He also described efforts to limit concomitant steroid impact through a taper plan that, if not followed, would render a patient a non-responder. In addition, he said the company has emphasized investigator training and uses a “crawler” to flag inconsistencies in trial data in near real time, allowing sites to be queried and re-educated as needed.
On what would constitute success, Babler said an oral drug with efficacy “as good as the anifrolumab data” would meet a baseline bar, given an existing benchmark in lupus. He reiterated his view that greater TYK2 inhibition could drive better outcomes, while noting uncertainties when comparing across doses and pharmacokinetic profiles in the class.
Separately, Babler said Alumis is refining a once-daily formulation for envudeucitinib, describing it as a lifecycle extension rather than something expected at launch. He said the company has achieved a once-daily formulation but is working to resolve a remaining aspect of the profile, and he emphasized that patients may prefer twice-daily dosing without a food effect over once-daily dosing with fasting requirements.
For A-005, Babler said the compound has shown strong brain penetration, describing a one-to-one ratio from blood to brain. He said the company is considering an imaging study in multiple sclerosis (MS) designed to help identify the best dose for central nervous system (CNS) disease. He also mentioned interest in other neuroinflammatory components of neurodegenerative diseases, including Alzheimer’s, Parkinson’s, and ALS, while noting the need to evaluate A-005 within the overall franchise strategy.
About Alumis (NASDAQ:ALMS)
Our mission is to significantly improve the lives of patients by replacing broad immunosuppression with targeted therapies. Our name, Alumis, captures our mission to enlighten immunology, and is inspired by the words “allumer”-French for illuminate-and “immunis”-Latin for the immune system. We are a clinical stage biopharmaceutical company with an initial focus on developing our two Tyrosine Kinase 2 (TYK2) inhibitors: ESK-001, a second-generation inhibitor that we are developing to maximize target inhibition and optimize tolerability, and A-005, a central nervous system (CNS) penetrant molecule.
