Executives at Amgen (NASDAQ:AMGN) outlined several upcoming clinical milestones and recent data updates across its inflammation and immunology portfolio, discussing expansion plans for UPLIZNA, new phase II results for daxdilimab in discoid lupus, progress in Sjögren’s syndrome studies for dazodalibep, and the company’s strategy for TEZSPIRE and pipeline TSLP programs.
UPLIZNA: Phase III plans in autoimmune hepatitis and CIDP
Amgen said it plans to initiate phase III studies later this year evaluating UPLIZNA in autoimmune hepatitis (AIH) and chronic inflammatory demyelinating polyneuropathy (CIDP). In explaining the rationale, the company pointed to its broader experience with B-cell depletion and to the role of pathogenic B-cells in both conditions, including autoantibody production and immune dysregulation.
Amgen characterized AIH as a liver inflammation condition that can lead to progressive scarring and loss of liver function, while CIDP was described as a disabling immune-driven neuropathy that damages peripheral nerves and myelin. The company said both diseases share similarities with IgG4-related disease and generalized myasthenia gravis, where UPLIZNA has shown durable clinical benefit.
On population sizing, Amgen estimated the prevalent U.S. CIDP pool at about 35,000 patients, with roughly 7,000 to 10,000 incident cases diagnosed annually. AIH was described as likely larger, though the company said it is difficult to pin down an absolute number. The executive also noted that with “impactful” medicines, physician diagnosis and treatment rates can rise, citing IgG4-related disease as an example.
Daxdilimab: Positive phase II in discoid lupus
Amgen discussed newly announced positive phase II results for daxdilimab in discoid lupus, following a prior phase II study in systemic lupus erythematosus (SLE) that did not show the efficacy the company had hoped for. Daxdilimab was described as a first-in-class molecule that targets ILT-7 (immunoglobulin-like transcript 7 protein), which is involved in plasmacytoid dendritic cell function and interferon production.
The company said discoid lupus is a skin manifestation with pathology driven by plasmacytoid dendritic cells and interferon production in the skin, which it said supports the mechanistic rationale for daxdilimab in that setting.
In the discoid lupus phase II study, Amgen said daxdilimab:
- Met the primary endpoint, a reduction in disease severity index at week 24
- Met a key secondary endpoint based on investigator-assessed global assessment of disease activity
Amgen also referenced a smaller 12-patient phase II study in dermatomyositis where the drug showed clinical benefit. The company said it is still evaluating the data and is “still thinking” about phase III design, including whether to focus specifically on discoid lupus or pursue a broader cutaneous lupus population. Executives also said they are methodically assessing other potential indications where plasmacytoid dendritic cells and interferon production may play a role, but did not provide specifics.
Dazodalibep: Sjögren’s syndrome phase III program and timing
Amgen said enrollment has wrapped in its pivotal studies for dazodalibep, a fusion protein that inhibits CD40 ligand. The company described the CD40/CD40 ligand axis as driving B-cell activation and cytokine production, with evidence it is active in Sjögren’s syndrome. By blocking the pathway, Amgen said it aims to interrupt upstream immune activation tied to autoantibody production and downstream inflammatory cascades.
The company’s phase III program includes two distinct Sjögren’s populations:
- Patients with moderate to severe systemic disease activity
- Patients with high symptomatic burden but low systemic disease activity
Amgen said Sjögren’s syndrome is currently managed largely symptomatically, including oral care, tear replacement, analgesia, and sometimes glucocorticoids and steroids, and emphasized the lack of a definitive therapy. The company referenced its 2024 phase II results, stating it observed improvement in disease activity index and patient-reported outcomes in both groups, which it said supports its confidence heading into phase III.
On regulatory strategy, Amgen said it would need to see how compelling the phase III data are before commenting on a potential approval path based on a single subgroup. The company said it expects phase III results in the second half of this year. Asked about FcRn-directed nipocalimab in Sjögren’s, the executive said it is difficult to compare until data are available, while noting Amgen believes it is the first therapy to show phase II efficacy in both of the studied patient groups.
TEZSPIRE and TSLP: Nasal polyps launch, upcoming readouts, and inhaled program
Amgen addressed TEZSPIRE’s label expansion in chronic rhinosinusitis with nasal polyps (CRSwNP) and positioned TEZSPIRE as an upstream approach versus therapies targeting downstream Th2 cytokines such as IL-4, IL-5, and IL-13. The company described CRSwNP as heterogeneous and often comorbid with asthma and said TEZSPIRE’s targeting of TSLP addresses upstream drivers related to epithelial dysfunction and immune activation, impacting multiple inflammatory pathways and inflammatory cell recruitment, including eosinophils.
Discussing the phase III Waypoint study supporting the CRSwNP approval, Amgen said TEZSPIRE demonstrated statistically significant, clinically meaningful reduction in nasal polyp severity, “almost complete elimination” of the need for surgery, and a large reduction in steroid use versus placebo.
On the overlap between asthma and nasal polyps, Amgen estimated coexistence at around 20% and said the nasal polyps indication can help reach more asthma patients due to shared underlying biology.
Looking ahead, Amgen highlighted ongoing phase III development in COPD and eosinophilic esophagitis (EoE) and said it expects TEZSPIRE to be a “durable growth driver well beyond 2026.” The company said low penetration in severe asthma and the new CRSwNP approval leave significant headroom. While asked about the impact of ultra long-acting biologics in asthma, the executive said those agents will need to demonstrate safety, durability, and meaningful clinical benefit before comparisons can be made.
In EoE, Amgen said it has not formally characterized epidemiology but cited literature suggesting U.S. prevalence of about 1 in 700 people. The company described current care as including proton pump inhibitors, surveillance, and possible steroid use, and said the disease represents a high unmet need. Amgen said the phase III EoE study is enrolled, with data expected in the second half of this year. The executive declined to define what would be clinically significant improvement on the Dysphagia Symptom Questionnaire endpoint ahead of results, emphasizing that interpretation often depends on totality of data and discussions with regulators and clinicians.
Beyond TEZSPIRE, Amgen said it is not pursuing additional TEZSPIRE indications at this time and is focused on execution in current and late-stage programs. The company also discussed AMG 104, an inhaled TSLP antibody fragment tested in phase II. Amgen said delivery mechanisms for inhaled biologics have been proven with other agents and cited encouraging phase I data consistent with TEZSPIRE’s effects. The company said the phase II study is expected to complete in the first half of this year and suggested AMG 104 could potentially be used ahead of injected biologics, depending on data and expert input.
About Amgen (NASDAQ:AMGN)
Amgen Inc (NASDAQ: AMGN) is a global biotechnology company founded in 1980 and headquartered in Thousand Oaks, California. The company focuses on discovering, developing, manufacturing and delivering human therapeutics that address serious illnesses. Amgen’s work centers on biologic medicines derived from cellular and molecular biology, with an emphasis on translating advances in human genetics and protein science into therapies for patients.
Amgen’s commercial portfolio has historically included biologics used in oncology, supportive care, nephrology, bone health and cardiovascular disease.
