REG - AstraZeneca PLC - Saphnelo met primary endpoint in TULIP-SC

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17/09/2025 07:05

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RNS Number : 6051Z  AstraZeneca PLC  17 September 2025

17 September 2025

Saphnelo self-administration TULIP-SC Phase III trial meets primary endpoint
in patients with systemic lupus erythematosus based on an interim analysis

Subcutaneous administration of first-in-class biologic Saphnelo demonstrates
statistically significant and clinically meaningful reduction in disease
activity

Positive high-level results from a pre-specified interim analysis of the Phase
III TULIP-SC trial in patients with systemic lupus erythematosus (SLE) showed
that the subcutaneous (SC) administration of AstraZeneca's Saphnelo
(anifrolumab) demonstrated a statistically significant and clinically
meaningful reduction in disease activity compared to placebo.(1) The  safety
profile observed in the interim analysis was consistent with the known
clinical profile of Saphnelo administered as an intravenous (IV)
infusion.(2-4)

 

The TULIP-SC trial evaluated the efficacy and safety of the subcutaneous
administration of Saphnelo compared to placebo in participants with moderately
to severely active, autoantibody-positive SLE, with both treatment groups
receiving standard therapy (oral corticosteroids, antimalarials, and/or
immunosuppressants).(5)

 

Affecting over 3.4 million people globally, SLE can impact any organ, leading
many patients to experience debilitating symptoms, irreversible organ damage
and poor health-related quality of life.(6-11) While oral corticosteroids are
often used to provide relief from symptoms of SLE patients, they are
associated with adverse events and short-term benefits without targeting the
underlying drivers of the disease, preventing patients from experiencing
adequate disease control and achieving remission.(12-14) Recent updates to
clinical guidelines elevate the importance of treating to target remission or
low disease activity and minimising the use of oral corticosteroids.(15,16)

 

Susan Manzi, MD, MPH, Professor of Medicine and Chair of the Medicine
Institute at Allegheny Health Network, Professor of Medicine at Drexel
University College, Philadelphia and principal investigator of the TULIP-SC
trial, said: "Today's results for subcutaneous anifrolumab reinforce the
efficacy and safety of this therapy and provide the opportunity for this
important biologic to reach a wider group of patients in a more flexible and
convenient way. Despite guidelines recommending earlier intervention and
biologic treatments, too many people with systemic lupus erythematosus rely on
oral corticosteroids, which contribute to irreversible organ damage."

 

Sharon Barr, Executive Vice President, BioPharmaceuticals R&D,
AstraZeneca, said: "Today's news takes us one step closer in making the
clinically meaningful benefits of Saphnelo accessible for more patients with
systemic lupus erythematosus. The TULIP-SC results are especially important
because approximately half of systemic lupus erythematosus patients today
taking a biologic are already treated with a self-administered subcutaneous
option. With Saphnelo, we hope to establish remission as an achievable
treatment goal for more patients and we are actively working with regulatory
authorities to bring this new administration option to patients as soon as
possible."

 

The reduction in disease activity in TULIP-SC was measured using the British
Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA) at week
52.(5) The BICLA requires improvement in all organs with disease activity at
baseline with no new flares.(5)

 

The TULIP-SC interim results are under regulatory review and will be presented
during the American College of Rheumatology (ACR) Convergence 2025 annual
meeting, 24-29 October 2025.

 

Saphnelo IV infusion is approved for the treatment of moderate to severe SLE
in more than 70 countries worldwide including the US, EU and Japan with
regulatory reviews ongoing in other countries. To date, more than 38,000
patients globally have been treated with Saphnelo.(17)

Notes

 

Financial considerations

AstraZeneca acquired global rights to Saphnelo through an exclusive license
and collaboration agreement with Medarex, Inc. in 2004. The option for Medarex
to co-promote the product expired on its acquisition by Bristol-Myers Squibb
(BMS) in 2009. Under the agreement AstraZeneca will pay BMS a low to mid-teens
royalty for sales dependent on geography.

 

Systemic lupus erythematosus

SLE is an autoimmune disease in which the immune system attacks healthy tissue
in the body.(18 )It is a chronic and complex disease with a variety of
clinical manifestations that can impact many organs and can cause a range of
symptoms, including pain, rashes, fatigue, swelling in joints and fevers.(9)

( )

Over 3.4 million people globally are affected by SLE, and it is among the
leading causes of death in young women in the US.(7,19)( )Living with SLE can
be painful, debilitating, have a profound impact on patients' mental and
financial well-being, and disproportionately affects women in their prime, and
those of Asian, Black or Hispanic racial/ ethnic
backgrounds.(6,7,11,20,21)

 

An estimated 50% of people with SLE have irreversible organ damage within five
years of diagnosis due to long-term corticosteroid use and disease
activity.(13,21,22) Even a small reduction in daily steroid use (for example 1
mg/day) can lower the risk of organ damage.(23)

 

TULIP-SC

TULIP-SC is a Phase III, multicentre, randomised, double-blind,
placebo-controlled study to evaluate the efficacy and safety of a subcutaneous
administration of anifrolumab versus placebo in participants with moderately
to severely active, autoantibody-positive SLE while receiving standard
therapy.(5)

 

Patients recruited were aged 18 to 70 years and must have been taking either
one or any combination of the following: oral corticosteroids, antimalarial,
and/or immunosuppressants. In the trial, 367 participants on standard therapy
were randomised 1:1 to receive 120mg subcutaneous dose of anifrolumab or
placebo administered once weekly via an accessorised prefilled syringe. A
planned interim analysis was conducted when the first 220 participants reached
week 52. The trial also includes an open-label extension period of 52 weeks
for participants who completed the 52-week treatment period.(5)

 
Saphnelo

Saphnelo (anifrolumab) is a first-in-class, fully human monoclonal antibody
that binds to subunit 1 of the type I interferon (IFN) receptor, blocking the
activity of type I IFN.(2,22) Type I IFNs, such as IFN-alpha, IFN-beta and
IFN-kappa, are cytokines involved in regulating the inflammatory pathways
implicated in SLE.(24-29)

 

Saphnelo continues to be evaluated in diseases where type I IFN plays a key
role, including Phase III trials in cutaneous lupus erythematosus, myositis,
systemic sclerosis and lupus nephritis.(30-33)

 

AstraZeneca in Respiratory & Immunology

Respiratory & Immunology, part of AstraZeneca BioPharmaceuticals, is a key
disease area and growth driver to the Company.

 

AstraZeneca is an established leader in respiratory care with a 50-year
heritage and a growing portfolio of medicines in immune-mediated diseases. The
Company is committed to addressing the vast unmet needs of these chronic,
often debilitating, diseases with a pipeline and portfolio of inhaled
medicines, biologics and new modalities aimed at previously unreachable
biologic targets. Our ambition is to deliver life-changing medicines that help
eliminate COPD as a leading cause of death, eliminate asthma attacks and
achieve clinical remission in immune-mediated diseases.

 

AstraZeneca (https://www.astrazeneca.com/)

AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical
company that focuses on the discovery, development, and commercialisation of
prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals,
including Cardiovascular, Renal & Metabolism, and Respiratory &
Immunology. Based in Cambridge, UK, AstraZeneca's innovative medicines are
sold in more than 125 countries and used by millions of patients worldwide.
Please visit astrazeneca.com (http://www.astrazeneca.com/)  and follow the
Company on social media @AstraZeneca
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Matthew Bowden

Company Secretary

AstraZeneca PLC

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