Primary Results of the Phase 1b Proof-of-Concept Study of NI006 to be presented at the ESC Heart Failure Congress 2023
Primary Results of the Phase 1b Proof-of-Concept Study of NI006 to be presented at the ESC Heart Failure Congress 2023
Zurich, Switzerland, May 17, 2023 – Neurimmune announced today that primary results of its Phase 1b proof-of-concept study of NI006, a recombinant human antibody to deplete amyloid deposits in ATTR cardiomyopathy, will be presented online and in Prague at Heart Failure 2023, a scientific congress of the European Society of Cardiology (ESC), on May 20, 4:40 pm CEST. Dr. Pablo Garcia-Pavia from the Hospital Universitario Puerta de Hierro and CNIC in Madrid, Spain, will present during the session for Late-Breaking Clinical Trials: Chronic Heart Failure and Cardiomyopathies.
Amyloid transthyretin cardiomyopathy (ATTR-CM) is increasingly recognized as a treatable cause of heart failure. Progressive ATTR amyloid depositions characterize the disease, leading to progressive heart failure and a high rate of fatality if left untreated. Despite recent advances in slowing disease progression, there is no treatment available to deplete cardiac ATTR amyloid and revert cardiac dysfunction.1,2,3
NI006 is designed to target the pathology of transthyretin amyloid cardiomyopathy by enabling depletion of amyloid fibrils in the heart.4 This Phase 1 study investigated safety, tolerability, pharmacology and efficacy at 12 months of NI006 treatment in ascending doses.
In 2022, Neurimmune entered into an exclusive global collaboration and license agreement with Alexion, AstraZeneca’s Rare Disease group, for NI006. Neurimmune is responsible for completion of the Phase 1b clinical study on behalf of Alexion, with Alexion incurring certain trial costs. Following the Phase 1b trial, Alexion will be responsible for further clinical development, manufacturing, and commercialization as ALXN2220 (NI006).
1 Garcia-Pavia et al., Eur Heart J 2021; 42(16):1554.
2 Kittleson et al., Circulation 2020; 142(1):e7.
3 Kittleson et al., J Am Coll Cardiol 2023; 81(11):1076.
4 Michalon 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, Parkinson’s disease, amyotrophic lateral sclerosis, frontotemporal dementia, dementia with Lewy bodies and ATTR cardiomyopathy. Neurimmune discovered aducanumab, a human monoclonal antibody that removes amyloid beta from brains of patients with Alzheimer’s disease, and licensed it to Biogen. With its Reverse Translational Medicine™ technology, Neurimmune also discovered the anti-miSOD1 antibody AP-101 for ALS and the anti-ATTR antibody NI006 for ATTR cardiomyopathy, programs being currently evaluated in clinical trials. Neurimmune has three additional antibody programs in preclinical development and has recently expanded the spectrum of its treatment modalities by adding a small molecule program and programs involving vectorized expression of human antibody genes.
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