17th Sep 2025 09:06
(Alliance News) - AstraZeneca PLC on Wednesday reported mixed updates from its late-stage pipeline, with a lupus treatment hitting its main goal in a phase III trial, while a chronic obstructive pulmonary disease candidate fell short.
The Cambridge, England-based pharmaceutical firm said subcutaneous Saphnelo achieved its primary endpoint in the TULIP-SC phase III trial, showing a statistically significant and clinically meaningful reduction in disease activity in patients with systemic lupus erythematosus. Lupus is an autoimmune condition.
The safety profile was consistent with that of the intravenous version, which is already approved in more than 70 countries.
AstraZeneca said the subcutaneous formulation could expand access to the medicine, as around half of lupus patients receiving a biologic today use a self-administered option. Regulatory review of the interim results is underway, with full findings due to be presented at the American College of Rheumatology annual meeting in late October.
Susan Manzi, principal investigator of the study, said the data "reinforce the efficacy and safety" of Saphnelo and highlight the potential for a more convenient treatment option. Sharon Barr, AstraZeneca's executive vice president of BioPharmaceuticals R&D, added that the company hopes to "establish remission as an achievable treatment goal for more patients" and is working with regulators to secure approval for the new administration route.
By contrast, AstraZeneca said its Fasenra failed to meet the primary endpoint in the phase III Resolute trial for COPD, despite showing numerical improvement. The study tested Fasenra in patients with frequent exacerbations and elevated eosinophil counts, but results did not reach statistical significance.
The company stressed that the safety and tolerability profile was consistent with Fasenra's existing approvals. The biologic is already used as a maintenance treatment for severe eosinophilic asthma in over 80 countries, as well as for eosinophilic granulomatosis with polyangiitis in adults.
Barr said COPD remains "a complex, heterogeneous disease" and noted AstraZeneca will continue advancing other approaches in its pipeline, while further analysing the Resolute dataset to share findings with the scientific community.
COPD is one of the most common chronic respiratory conditions globally, affecting an estimated 391 million people, and is among the leading causes of mortality globally.
Shares in AstraZeneca were down 0.5% at 11,286.12 pence in London on Wednesday morning.
By Eva Castanedo, Alliance News reporter
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