FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of April 2026
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
I CAN PhIII interim analysis met primary endpoint
21 April 2026
Ultomiris demonstrated
statistically significant and clinically meaningful reduction of
proteinuria in adults with immunoglobulin A nephropathy
in
I CAN Phase III trial
Ultomiris delivered rapid reduction in proteinuria as early as week
10
Results show potential for terminal C5 complement inhibition with
Ultomiris as a disease-modifying treatment option for
IgAN
Positive high-level results from a prespecified interim analysis of
the I CAN Phase III trial showed that Ultomiris (ravulizumab) met its primary endpoint,
demonstrating a statistically significant and clinically meaningful
reduction of proteinuria, based
on 24-hour urine protein creatinine ratio
(UPCR), at
week 34 in adults with immunoglobulin A nephropathy (IgAN) who are
at risk of disease progression. The
primary endpoint of change from baseline in estimated glomerular
filtration rate (eGFR) will be measured at week
106.
IgAN is a rare, inflammatory
disease of the kidneys that can lead to chronic
kidney disease (CKD) and progress to end-stage kidney
disease (ESKD). It begins when the body develops abnormal IgA
proteins resulting in immune complexes that are deposited in the
kidneys causing damage. The deposition of these complexes activates
the complement system, leading to terminal complement-driven
inflammation. This results in damage and loss of essential parts of
the kidney, including cells in the glomeruli, the part of the
kidneys that filters and cleans the blood. Over time, this damage
impacts the ability of the kidneys to function
properly.1
More than 560,000 people are diagnosed with IgAN in the US, EU5 and
Japan, of which more than 60 percent are eligible for IgAN
treatment.2-5
Jonathan Barratt, MD, Mayer Professor of Renal Medicine, University
of Leicester, United Kingdom, and I CAN trial investigator,
said: "Many people living with IgAN continue to progress to
kidney failure, ultimately requiring dialysis or a transplant -
outcomes that can place profound burden on patients' daily lives -
despite advances in care. The interim I CAN results demonstrate
that blocking terminal complement activation, a central driver
of kidney inflammation in IgAN, with Ultomiris may play a promising role in reducing
proteinuria. We look forward to
understanding the full clinical impact of Ultomiris in treating this disease following study
completion at two years."
Marc Dunoyer, Chief Executive Officer, Alexion, AstraZeneca Rare
Disease, said: "These
positive data demonstrate that C5 complement inhibition
with Ultomiris results in a rapid and clinically meaningful
reduction in proteinuria as early as week 10 and underscores its
potential as a disease-modifying approach in
IgAN. We
look forward to filing these data with regulatory authorities in
key regions, while in parallel, advancing this Phase III trial
towards completion."
The safety profile observed in this trial was consistent with the
known profile of Ultomiris, with no new safety concerns
identified.
The company will seek accelerated approval in key markets
and will
present these results at a forthcoming medical
meeting.
Notes
Immunoglobulin A Nephropathy (IgAN)
Immunoglobulin A nephropathy (IgAN) is a rare, inflammatory disease
of the kidneys that can lead to chronic kidney disease (CKD) and
progress to end-stage kidney disease (ESKD). It begins when the
body develops abnormal IgA proteins resulting in immune complexes
that are deposited in the kidneys causing damage. The deposition of
these complexes activates the complement system, leading
to terminal complement-driven inflammation. This results
in damage and loss of essential parts of the kidney, including
cells in the glomeruli, the part of the kidneys that filters and
cleans the blood. Over time, this damage impacts the ability of the
kidneys to function properly, resulting in chronic kidney disease
that can progress to end-stage kidney disease.1
The signs and symptoms of IgAN can include blood in the urine
(haematuria), foamy urine (proteinuria), swelling in hands and feet
(oedema) and high blood pressure (hypertension).6 Most
people with IgAN do not experience symptoms in the early stages of
the disease, and therefore, it often goes undetected until it has
progressed. At diagnosis, irreversible kidney damage may have
already occurred.5,7 Approximately
half of people with IgAN who have elevated protein levels in urine
or reduced kidney function are at-risk of progression to ESKD, or
kidney failure, within 10 years of diagnosis.8
I CAN (ALXN1210-IgAN-320)
I CAN (ALXN1210-IgAN-320) is a global, Phase III, randomised,
double-blind, placebo-controlled trial evaluating the efficacy and
safety of Ultomiris in adults with immunoglobulin A nephropathy
(IgAN) who
are at risk of disease progression. Participants were on stable
concomitant IgAN treatment(s) consistent with standard of care for
at least three months prior to screening.9
Participants were randomised 1:1 to receive
either Ultomiris or placebo, administered intravenously for a
total of 106 weeks. Patients in the treatment arm received a
loading dose of Ultomiris on Day 1, followed by regular weight-based
maintenance dosing of Ultomiris beginning on Day 15 and then every eight
weeks through the 106-week blinded treatment period. Patients who
completed the randomised control period had the option to enter an
open-label access period.9
The primary endpoints are change from baseline in proteinuria based
on 24-hour urine protein creatinine ratio (UCPR) at week 34 and
change from baseline in estimated glomerular filtration rate (eGFR)
at week 106, assessed at the interim analysis and final analysis,
respectively. Key secondary endpoints for the final analysis
include reduction in 24-hour UPCR ≥ 50% from baseline at week
34, change from baseline in proteinuria based on 24-hour UPCR at
week 10, time to sustained ≥ 30% eGFR decline up to week 106
and time
to first occurrence of composite kidney event up to week
106. The
trial was designed to enrol approximately 510 participants from 28
countries across North America, South America, Europe, Asia and
Australia.9
Ultomiris
Ultomiris (ravulizumab),
the longest-acting C5 complement inhibitor, provides immediate,
complete and sustained complement inhibition. The medication works
by inhibiting the C5 protein in the terminal complement cascade, a
part of the body's immune system. When activated in an uncontrolled
manner, the complement cascade over-responds, leading the body to
attack its own healthy cells. Following a loading
dose, Ultomiris is
administered intravenously every eight weeks in adults, or every
four or eight weeks in paediatric patients (based on body
weight).
Ultomiris is
approved in the US, EU, Japan and other countries for the treatment
of certain adults with paroxysmal nocturnal haemoglobinuria (PNH)
and is also approved for certain children with PNH in the US, EU
and other countries.
Ultomiris is
also approved in the US, EU, Japan and other countries for the
treatment of certain adults and children with atypical haemolytic
uraemic syndrome (aHUS).
Additionally, Ultomiris is
approved in the US, EU, Japan, China and other countries for the
treatment of certain adults with generalised myasthenia gravis
(gMG).
Further, Ultomiris is
approved in the US, EU, Japan, China and other countries for the
treatment of certain adults with neuromyelitis
optica spectrum disorder (NMOSD).
Ultomiris is
being assessed as a treatment for additional indications as part of
a broad development programme.
Alexion
Alexion, AstraZeneca Rare Disease, is focused on serving patients
and families affected by rare diseases and devastating conditions
through the discovery, development and delivery of life-changing
medicines. A pioneering leader in rare disease for more than three
decades, Alexion was the first to translate the complex biology of
the complement system into transformative medicines, and today it
continues to build a diversified pipeline across disease areas with
significant unmet need, using an array of innovative modalities. As
part of AstraZeneca, Alexion is continually expanding its global
geographic footprint to serve more rare disease patients around the
world. It is headquartered in Boston, US.
AstraZeneca
AstraZeneca (LSE/STO/NYSE: 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 and
follow the Company on Social Media @AstraZeneca.
Contacts
For details on how to contact the Investor Relations Team, please
click here.
For Media contacts, click here.
References
1. Cheung CK, et al. The pathogenesis
of IgA nephropathy and implications for
treatment. Nat Rev
Nephrol. 2025;21(1):9-23.
doi:10.1038/s41581-024-00885-3. Epub 2024 Sep
4.
2. DeCongelio M, et al. The incidence
and prevalence of immunoglobulin A nephropathy in the United
States. Clin
Nephrol.
2025;103(1):19-25.
3. Buisker J, et al. The prevalence of
immunoglobulin A nephropathy in the European Union and the impact
of the COVID-19 pandemic: an estimation approach utilizing the
kidney biopsy frequency. Clin Kidney
J. 2025;
18(4):sfaf068.
4. Sugiyama H, et al. Japan Renal
Biopsy Registry and Japan Kidney Disease Registry: Committee Report
for 2009 and 2010. Clin Exp
Nephrol. 2013;17(2):
155-173.
5. Kidney Disease: Improving Global
Outcomes (KDIGO) IgAN and IgAV Work Group, et al. KDIGO 2025
Clinical Practice Guideline for the Management of Immunoglobulin A
Nephropathy (IgAN) and Immunoglobulin A Vasculitis
(IgAV). Kidney Int. 2025; 108(4S): S1-S71.
6. Rajasekaran A, et al. IgA
Nephropathy: An Interesting Autoimmune Kidney
Disease. Am J Med
Sci. 2021;
361(2):176-194.
7. Stamellou
E, et al. IgA nephropathy. Nat
Rev Dis Primers. 2023;9(1):67.
doi:10.1038/s41572-023-00476-9.
8. Wong K, et al. Effects of rare
kidney diseases on kidney failure: a longitudinal analysis of the
UK National Registry of Rare Kidney Diseases (RaDaR)
cohort. Lancet. 2024;403(10433):1279-1289.
9. ClinicalTrials.gov.
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to
Evaluate the Efficacy and Safety of Ravulizumab in Adult
Participants With Immunoglobulin A Nephropathy (IgAN). NCT
Identifier: NCT06291376. Available here.
Accessed April 2026.
Matthew Bowden
Company Secretary
AstraZeneca PLC
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
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AstraZeneca
PLC
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Date: 21 April 2026
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By: /s/
Matthew Bowden
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Name:
Matthew Bowden
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Title:
Company Secretary
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