Neurimmune today announced it has initiated a Phase 2 follow-on study to evaluate the pharmacodynamics and safety of cliramitug (formerly ALXN2220, NI006) for transthyretin amyloid cardiomyopathy (ATTR-CM) in patients who were previously enrolled in the proof-of-concept study NI006-101 (NCT04360434). Cliramitug is an investigational human monoclonal antibody designed to deplete amyloid deposits in ATTR-CM.1,2
The Phase 2, single-arm, multicenter study NI006-102 (NCT07213583) will evaluate the pharmacodynamic effects and safety of re-treatment with cliramitug in patients who were previously treated with cliramitug. The study will explore changes in cardiac amyloid load, cardiac structure and function, and clinical function.
“The initiation of this Phase 2 follow-on study marks an important step up in our collaboration with Alexion, enabling us to broaden our understanding of the long-term treatment effects of cliramitug,” said Christoph Hock, MD, Chief Medical Officer of Neurimmune. “Our joint objective with our partner Alexion, AstraZeneca Rare Disease, is to develop a potential first-in-class therapeutic to deplete cardiac amyloid in patients affected by ATTR-CM, driven by our profound dedication to improving patient long-term outcomes.”
ATTR-CM is a systemic and potentially life-threatening disease caused by the deposition of misfolded transthyretin (TTR), which presents with progressive heart failure. Despite advances in slowing disease progression, there is no available treatment option designed to deplete TTR from the heart to revert cardiac dysfunction.
Alexion is currently conducting the pivotal Phase 3 DepleTTR-CM clinical study (NCT06183931) to assess the efficacy of cliramitug by evaluating its effect on all-cause mortality and clinically important cardiovascular events. In the previous Study NI006-101, treatment with cliramitug for more than a year was not associated with apparent drug-related serious adverse events, and surrogate markers of cardiac amyloid load indicated cardiac ATTR depletion along with improvement of cardiac biomarkers and function.2
In 2022, Neurimmune entered into an exclusive global collaboration and license agreement with Alexion for cliramitug. Neurimmune is responsible for the Phase 2 follow-on study (NI006-102), on behalf of Alexion. Alexion is responsible for further clinical development, manufacturing, and commercialization of cliramitug.
1Garcia-Pavia et al., N Engl J Med 2023; 389(3):239.
2Michalon et al., Nat Commun 2021; 12(1):3142.
About Neurimmune
Neurimmune is a biopharmaceutical company translating human immune memory into antibody therapeutics. Neurimmune develops drug candidates for CNS and related protein aggregation diseases including Alzheimer’s disease, amyotrophic lateral sclerosis and ATTR cardiomyopathy. With its Reverse Translational MedicineTM technology, Neurimmune discovered the anti-ATTR antibody cliramitug (formerly ALXN2220, NI006) for ATTR cardiomyopathy, the anti-SOD1 antibody AP-101 for ALS and the anti-NogoA antibody NG004 for spinal cord injury, programs being currently evaluated in clinical trials.
Contact for Media
John Capodanno (US)
john.capodanno@dentonsglobaladvisors.com
Martin Meier-Pfister (Switzerland)
media@neurimmune.com
