Amgen's dazodalibep hits primary endpoint in first Phase 3 Sjögren's trial
核心洞察
Amgen's dazodalibep met the primary objective of the first of two pivotal Phase 3 trials in Sjögren's syndrome (搜索), producing a statistically significant and clinically meaningful improvement in disease activity at 48 weeks.
Amgen reported no imbalance in blood clots or opportunistic infections, a concern for drugs targeting the CD40-CD40L (搜索) pathway, with side effects generally mild to moderate.
Full OASIZ 301 data will be presented at a future medical meeting, leaving open how dazodalibep compares with Novartis' ianalumab and Bristol Myers Squibb (搜索)'s Sotyktu in the same indication.
Amgen's experimental drug dazodalibep met the primary objective of the first of two Phase 3 trials in Sjögren's syndrome (搜索), the company said Tuesday, reporting a statistically significant and clinically meaningful improvement on a widely used measure of disease activity after 48 weeks of treatment.
Amgen did not disclose specific efficacy figures. The company said positive effects were observed as early as four weeks after treatment and persisted through the evaluation period. Detailed findings will be presented at a future medical meeting.
Safety profile in the CD40-CD40L class
Investigators did not observe an imbalance in the rate of blood clots or opportunistic infections in the Phase 3 study, a potential concern for drugs with dazodalibep's mechanism. Amgen said side effects were generally mild to moderate, and study discontinuations were infrequent and balanced across study arms.
Dazodalibep interferes with a key communication channel between immune cells. Blocking the CD40-CD40L (搜索) pathway is intended to blunt the hyperactive immune response and the formation of tissue-damaging autoantibodies in Sjögren's syndrome (搜索). In earlier Phase 2 testing, participants experienced a reduction in symptoms and disease activity.
An indication without approved disease-modifying options
Sjögren's syndrome (搜索) has been a difficult target for drugmakers. No approved treatments can alter the course of the condition, in which the immune system attacks moisture-producing glands and causes chronic dry eyes and mouth, pain, inflammation and other health problems. Patients also face a higher risk of lymphoma (搜索).
"These topline results provide further support for dazodalibep as an emerging treatment for improving systemic disease activity and represent an important advance for the field," said Ghaith Noaiseh, the study's lead investigator and an immunology professor at the University of Kansas Medical Center, in a statement provided by Amgen.
Second pivotal trial due in the fourth quarter
The results announced Tuesday come from the first of two pivotal studies in Sjögren's syndrome (搜索). The second trial, in patients who have a high symptom burden, is expected to produce data in the fourth quarter. The two Phase 3 trials involve distinct patient populations, and Amgen will need victories in both to win regulatory approval, William Blair analyst Matt Phipps wrote in a note.
Dazodalibep has changed hands several times. It was originally discovered by AstraZeneca, which spun it into a startup, Viela Bio (搜索), that Horizon Therapeutics (搜索) acquired in 2021. Amgen bought Horizon two years later, inheriting dazodalibep along with multiple other prospects. The drug is now among the more closely watched assets in Amgen's pipeline.
Competitive positioning still unclear
Without detailed findings, it is not yet clear how dazodalibep stacks up against other emerging competitors. Novartis has an experimental therapy called ianalumab that could be cleared by regulators this quarter. Bristol Myers Squibb (搜索) is also due to report Phase 3 data testing its drug Sotyktu, a marketed treatment for psoriasis, in Sjögren's syndrome (搜索).
The study specifics Amgen eventually presents will "help inform positioning" against ianalumab, Leerink Partners analyst David Risinger wrote in a note to clients. Risinger added that his team and other analysts have "very low expectations" for the Bristol Myers study. Phipps wrote that he was "encouraged" by the announcement given his team had viewed the dazodalibep program as "relatively high risk."