Alumis Announces New Phase 3 Data Demonstrating Envudeucitinib Rapidly and Durably Improved Psoriasis Burden Across Scalp, Itch, and Quality of Life Measures
Patients switching from placebo or apremilast achieved responses comparable to continuous treatment at Week 48.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Alumis (ALMS) announced new Phase 3 envudeucitinib results showing improvements in scalp psoriasis, itch and quality of life across the ONWARD program. At Week 48, complete skin clearance reached 54%, over 80% maintained clear or almost clear scalp skin, and nearly 80% sustained clinically meaningful itch reduction.
In ONWARD1/2, approximately one-third achieved clinically meaningful itch reduction by Week 2. By Week 16, about 40% had complete itch resolution and approximately 60% had minimal or no itch. Approximately 50% reported minimal to no psoriasis impact on daily activities by Week 12; more than 70% maintained that outcome in ONWARD3 at 48 weeks. Patients switching from placebo or apremilast achieved responses comparable to continuous treatment at Week 48. No new safety signals emerged with long-term ONWARD3 exposure. Alumis remains on track to submit a new drug application in 4Q 2026 for moderate-to-severe plaque psoriasis.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Moderate pointComplete skin clearance reached 54% at Week 48 in ONWARD3.
- Moderate pointScalp clearance: over 80% in ONWARD3 maintained clear or almost clear scalp skin at 48 weeks.
- Moderate pointEarly itch relief: approximately one-third in ONWARD1/2 achieved clinically meaningful reduction as early as Week 2.
- Moderate pointComplete itch resolution reached about 40% at Week 16 in ONWARD1/2.
- Moderate pointMinimal or no itch reached approximately 60% at Week 16 in ONWARD1/2.
- Moderate pointDurable itch relief: nearly 80% in ONWARD3 sustained clinically meaningful reduction through Week 48.
- Moderate pointQuality of life: approximately 50% in ONWARD1/2 achieved minimal to no daily impact by Week 12.
- Moderate pointDurable quality of life: more than 70% in ONWARD3 maintained minimal to no daily impact at 48 weeks.
- Moderate point. Forward-looking: it has not happened yet and may not happen.Alumis remains on track for a 4Q 2026 new drug application for moderate-to-severe plaque psoriasis.
2 minor points
- Minor pointPatients switching from placebo or apremilast achieved responses comparable to continuous treatment at Week 48.
- Minor pointLong-term ONWARD3 exposure showed no new safety signals; treatment was generally well tolerated across ONWARD.
Negative
- None.
Key Figures
- Scalp clear or almost clear
- Over 80%
- ONWARD3, 48 weeks; ss-PGA 0/1
- Clinically meaningful itch reduction
- Approximately one-third
- ONWARD1/2, as early as Week 2; includes patients with moderate-to-severe scalp disease
- Complete itch resolution
- About 40%
- ONWARD1/2, Week 16; NRS 0
- Minimal or no itch
- Approximately 60%
- ONWARD1/2, Week 16; NRS 0/1
- Sustained itch reduction
- Nearly 80%
- ONWARD3, through Week 48
- DLQI score of 0 or 1
- Approximately 50%
- ONWARD1/2, by Week 12
- Maintained DLQI score of 0 or 1
- More than 70%
- ONWARD3, at 48 weeks
- NDA submission timing
- 4Q 2026
- Company said submission for envudeucitinib in plaque psoriasis remained on track
Previous Clinical trial Reports
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Overall trial population missed the primary BICLA endpoint and key secondary endpoints.
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Reported ONWARD1/2 psoriasis efficacy, including skin-clearance outcomes and superiority to placebo and apremilast.
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Reported ONWARD3 48-week PASI 90 and PASI 100 skin-clearance rates in 773 patients.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
tyk2 inhibitor medical
pasi medical
dlqi medical
nda regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
– Results build on ONWARD3 highest complete skin clearance (
– Patients switching from placebo or apremilast achieved rapid responses, comparable to those on continuous treatment at Week 48
– On track to submit an NDA for envudeucitinib in moderate-to-severe plaque psoriasis in 4Q 2026
SOUTH SAN FRANCISCO, Calif., Oct. 09, 2026 (GLOBE NEWSWIRE) -- Alumis Inc. (Nasdaq: ALMS), a late-stage biopharmaceutical company developing next-generation targeted therapies for patients with immune-mediated diseases, today announced new envudeucitinib data from the ONWARD Phase 3 clinical program—ONWARD1, ONWARD2, and the long-term extension ONWARD3. The results, presented at the 26th Annual Fall Clinical Dermatology Conference, reinforce the potential of envudeucitinib to become a leading oral therapy for patients with moderate-to-severe plaque psoriasis. Envudeucitinib is an investigational, next-generation oral TYK2 inhibitor precision-engineered for maximal 24-hour target inhibition.
New data across key measures of disease burden build on envudeucitinib’s high-threshold skin clearance across the ONWARD program, including a
“For people living with psoriasis, achieving early and sustained relief in difficult-to-treat areas like the scalp and reduction of burdensome symptoms like itch are outcomes that can meaningfully improve quality-of-life,” said Mark Lebwohl, MD, Dean for Clinical Therapeutics at the Icahn School of Medicine at Mount Sinai. “The consistency of these findings across the ONWARD3 program—alongside high-threshold skin clearance and a favorable tolerability profile—is highly encouraging and underscores the clinical relevance of targeted TYK2 inhibition designed for maximal 24-hour target coverage.”
Fall Clinical Data* Highlights:
- High-rate of scalp clearance: Over
80% of patients in ONWARD3 maintained clear or almost clear scalp skin (scalp-specific Physician Global Assessment [ss-PGA] 0/1) at 48 weeks. - Rapid, robust and sustained itch relief: In ONWARD 1/2, approximately one-third of patients—including those with moderate-to-severe scalp disease (ss-PGA ≥3)—achieved clinically meaningful itch reduction (≥4-point NRS improvement) as early as Week 2. By Week 16, about
40% reached complete itch resolution (NRS 0) and approximately60% reported minimal or no itch (NRS 0/1). In ONWARD3, nearly80% of patients sustained clinically meaningful itch reduction through Week 48. - Early, durable quality-of-life improvements: Approximately
50% of patients in ONWARD 1/2 achieved a Dermatology Life Quality Index (DLQI) score of 0 or 1 by Week 12, reflecting minimal to no impact of psoriasis on daily activities. In ONWARD3, more than70% of patients maintained DLQI 0/1 at 48 weeks. - Rapid crossover convergence: Patients switching from placebo or apremilast achieved rapid improvements across primary and key secondary endpoints, comparable to those continuously treated at Week 48
*ONWARD3: N=1,509, data reported from non-responder imputation analysis in 773 patients from envudeucitinib arms who received up to 48 weeks of continuous treatment (24 weeks in ONWARD1/2 and up to 24 weeks in ONWARD3). ONWARD1/2: N=1771 (envudeucitinib n=459, 433; placebo n=230, 211, apremilast n=223, 215, respectively).
Treatment with envudeucitinib was generally well tolerated in the ONWARD program. No new safety signals were observed with long-term exposure in ONWARD3.
“The dataset presented at Fall Clinical further demonstrates envudeucitinib’s highly competitive clinical profile, reinforcing the strength of our precision engineering approach and its potential to become a leading therapy in the oral psoriasis market,” said Martin Babler, Chief Executive Officer of Alumis. “With our fourth-quarter 2026 NDA submission firmly on track, our organization is focused on regulatory execution and building the foundation designed to bring this next-generation therapy to patients.”
About the Phase 3 ONWARD Clinical Program
The Phase 3 ONWARD clinical program includes two parallel global, multicenter, randomized, double-blind, placebo- and active-comparator-controlled 24-week trials—ONWARD1 (NCT06586112) and ONWARD2 (NCT06588738)—evaluating the efficacy and safety of envudeucitinib in adults with moderate-to-severe plaque psoriasis. More than 1,700 patients were enrolled and randomized 2:1:1 to receive envudeucitinib 40 mg twice daily, placebo, or apremilast.
Patients completing Week 24 of ONWARD1 or ONWARD2 were eligible to enter the ONWARD3 (NCT06846541) study, an ongoing long-term extension study assessing durability, maintenance of response, and long-term safety. In ONWARD3, all patients received open-label envudeucitinib treatment for the first 24 weeks, regardless of their treatment assignment in ONWARD1 and 2. To assess durability and maintenance of response, the first 200 patients achieving PASI 75 at Week 24 in ONWARD3 could enter a 24-week randomized withdrawal period (RWP), in which they were randomized to receive either blinded envudeucitinib or placebo, and reassigned to open-label envudeucitinib upon loss of response or completion of the RWP, whichever occurred first. Patients not entering the randomized withdrawal period continued to receive open-label envudeucitinib treatment. ONWARD3 is designed to provide up to 96 weeks of long-term safety and efficacy data.
About Envudeucitinib
Envudeucitinib is a next-generation, highly selective, oral allosteric inhibitor of tyrosine kinase 2 (TYK2) precision-engineered for maximal 24-hour TYK2 inhibition to correct immune dysregulation across a range of diseases driven by IL-23, IL-17, and Type I interferon. It is the only TYK2 inhibitor shown to deliver maximal target inhibition over 24 hours in humans, with clinical data demonstrating sustained TYK2 blockade in patients with psoriasis while minimizing off-target binding and effects. Envudeucitinib has been administered with or without food, with no fasting requirement. Alumis has reported positive results from its Phase 3 ONWARD program of envudeucitinib in moderate-to-severe plaque psoriasis and plans to file an NDA in moderate-to-severe plaque psoriasis in the fourth quarter of 2026.
About Plaque Psoriasis
Plaque psoriasis is a chronic, immune-mediated disease driven by dysregulated IL-23 and IL-17 pathways that cause painful, itchy, scaly patches. It affects more than 8 million adults in the U.S. and often involves high-impact areas such as the scalp, face, hands, feet, and nails, significantly disrupting daily life. According to the National Psoriasis Foundation, about one in four patients has moderate-to-severe disease, based on quality-of-life impact and body surface area involved. Many remain inadequately controlled on current oral and topical treatments, underscoring the need for more effective, safe, and durable oral options that address the full burden of disease.
About TYK2 in Immune-Mediated Disease
Tyrosine kinase 2 (TYK2) is a key immune-signaling enzyme that regulates pathways across innate and adaptive immunity, including the IL-23/IL-17 axis and Type I interferon signaling that drive many high-burden immune-mediated diseases. Selective TYK2 inhibition has been widely validated as an effective, safe, and well-tolerated therapeutic approach. Genomic analyses conducted by Alumis highlight TYK2’s broad therapeutic potential, showing that it contributes to the pathogenesis of roughly 20 immune-driven conditions - including psoriasis, lupus, Sjögren’s disease, cutaneous lupus erythematosus, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. Additional evidence supports a genetic rationale for TYK2 inhibition in neuroinflammatory and neurodegenerative diseases where targeting TYK2 may offer a novel approach to treatment.
About Alumis
Alumis is a late-stage biopharma company developing next-generation targeted therapies with the potential to significantly improve patient health and outcomes across a range of immune-mediated diseases. Leveraging its proprietary data analytics platform and precision approach, Alumis is developing a pipeline of oral tyrosine kinase 2 inhibitors, consisting of envudeucitinib for the treatment of systemic immune-mediated disorders, such as moderate-to-severe plaque psoriasis and systemic lupus erythematosus, and A-005 for the treatment of neuroinflammatory and neurodegenerative diseases, such as Parkinson’s disease. In addition, the pipeline includes several preclinical programs identified through this precision approach. For more information, visit www.alumis.com or follow us on LinkedIn or X.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of federal securities laws, including the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements generally may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and similar expressions intended to identify forward-looking statements. All statements contained in this press release other than statements of historical facts are forward-looking statements, including without limitation statements regarding: Alumis’ plans to submit an NDA for envudeucitinib in the fourth quarter of 2026; the therapeutic potential of TYK2 inhibition across immune-mediated diseases and the potential multi-indication opportunity for envudeucitinib; the advancement of Alumis’ clinical pipeline; the potential for envudeucitinib to be a leading oral therapy in plaque psoriasis; and Alumis’ future plans, strategy, prospects and anticipated milestones, as well as the assumptions underlying any of the foregoing. Forward-looking statements are based on Alumis’ current expectations, estimates, assumptions and projections as of the date of this press release and are subject to significant risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such statements. Readers are cautioned that actual results, timing, safety, efficacy, performance or events and circumstances may differ materially from those expressed or implied in Alumis’ forward-looking statements due to a variety of risks and uncertainties including, without limitation, whether regulatory authorities accept for filing Alumis’ planned NDA submission as well as determine that envudeucitinib demonstrates an acceptable safety and efficacy profile and grant regulatory approval in moderate-to-severe plaque psoriasis; the potential for envudeucitinib to be developed in additional indications; the timing and results of clinical trials; Alumis’ ability to obtain regulatory approval of and ultimately commercialize its product candidates, Alumis’ ability to obtain sufficient funding and achieve anticipated development objectives, and Alumis’ ability to obtain, maintain and enforce intellectual property protection for its programs and product candidates. Additional information regarding these and other risks and uncertainties are contained under the heading “Risk Factors” and elsewhere in Alumis’ filings with the Securities and Exchange Commission (SEC), including its most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and subsequent filings with the SEC. Alumis explicitly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.
Alumis Contact Information Teri Dahlman, Red House Communications teri@redhousecomms.com
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What complete skin clearance result did Alumis report for envudeucitinib in ONWARD3?
Envudeucitinib achieved a 54% complete skin clearance response rate at Week 48. This was measured using PASI 100, meaning complete clearance on the Psoriasis Area and Severity Index.
When does Alumis plan to submit envudeucitinib for approval in plaque psoriasis?
Alumis remains on track to submit a new drug application in 4Q 2026 for envudeucitinib in moderate-to-severe plaque psoriasis.
Which patients were included in Alumis's ONWARD3 48-week analysis?
The reported ONWARD3 analysis used 773 patients from the envudeucitinib arms who received up to 48 weeks of continuous treatment. This comprised 24 weeks in ONWARD1/2 and up to 24 weeks in ONWARD3. The analysis used non-responder imputation, which counts missing responses as nonresponses; total ONWARD3 enrollment was 1,509.
How did Alumis define clinically meaningful itch reduction in the ONWARD trials?
Clinically meaningful itch reduction meant a ≥4-point improvement on the itch Numeric Rating Scale. Complete itch resolution was a score of 0, while minimal or no itch was a score of 0 or 1.