Express 98.6% reduction in recurrence risk! AstraZeneca's Phase 3 clinical results for autoimmune disease therapy are impressive

Today, AstraZeneca announced positive results
from a Phase 3 clinical trial of Ulomiris (ravulizumab), a long-acting complement C5 protein inhibitor developed by its subsidiary Alexion, in the treatment of neuromyelitis optica spectrum disease (NMOSD).
Data analysis showed that Utotris was able to reduce the risk of recurrence in NMOSD patients with anti-AQP4 antibodies by 98.
6% compared to the external placebo arm! Detailed data were presented at
this year's Congress of the European Council for Multiple Sclerosis and Research (ECTRIMS).

NMOSD is a rare, disabling central nervous system (CNS) autoimmune disease that affects up to hundreds of thousands of people
worldwide.
The main symptom is inflammatory lesions
of the optic nerve and spinal cord.
Patients with NMOSD often experience relapses of the disease, and repeated attacks by the immune system on their own tissues can lead to the gradual accumulation of nerve damage and disability
.

Complement protein C5 is at the end of the complement cascade, so targeting this protein can regulate complement signaling
activated by all three different pathways.
In a variety of complement-mediated immune diseases, the complement-mediated immune response attacks the patient's own healthy tissues and cells, causing damage
to different tissues and organs.
Inhibiting the activity of C5 can suppress the autoimmune attack, thereby alleviating the symptoms
of the disease.
Ultomiris has received FDA approval for the treatment of a variety of autoimmune diseases, including paroxysmal nocturnal hemoglobinuria and myasthenia gravis
.

The CHAMPION-NMOSD trial announced this time is an open-label, multicenter, global Phase 3 clinical trial to examine the efficacy and safety of Utomiris in adult NMOSD patients, with a total of 58 patients enrolled
.
This trial used data from the Soliris PREVENT key clinical trial as an external placebo arm
.

Data analysis showed that no identified recurrence (98.
6% reduction in recurrence risk, HR: 0.
014, 95% CI: 0.
000-0.
103, p<0.
0001) was observed after a median of 73 weeks of treatment with Ultomiris.

In addition, at week 48, 100% of patients treated with Ultomiris remained relapse-free, compared to 63%
in the external placebo group.
The trial also met a number of key efficacy endpoints, including the annual recurrence rate as judged in the trial and the clinically generated change in the patient's walking ability compared to baseline, as assessed by the Hauser walking metric
.

In general, the safety and tolerability of Utomiris in trials was good, consistent with
previously observed safety results.
The most common adverse reactions were COVID infection (24%), headache (24%), back pain (12%), joint pain (arthralgia) and urinary tract infection (10%)
.
Among them, the patient's new crown infection was judged to be unrelated
to the treatment of Ultomiris.

Dr.
Gianluca Pirozzi, Head and Senior Vice President of R&D Safety at Alexion, said: "The CHAMPION-NMOSD trial is an excellent example of
innovation.
This is achieved
by designing and executing scientifically rigorous and clinically significant rare disease trials.
By seeking patient input and communicating with regulators, this Phase 3 trial puts patients first, measuring parameters that are important to most patients
.
We are excited
about the importance of this result and Ultomiris' ability to advance the care of the NMOSD patient population.
" ”

Resources:

[1] Ultomiris showed zero relapses in adults with neuromyelitis optica spectrum disorder (NMOSD) with median treatment duration of 73 weeks.
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