Neurimmune Announces the Initiation of a Phase 1 Study of NI006 for the Treatment of ATTR Cardiomyopathy

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Feb 27, 2020, 08:00 ET

ZURICH, Feb. 27, 2020 /PRNewswire/ -- Neurimmune AG, the discoverer of aducanumab and cinpanemab, announced today enrollment of the first patient in a Phase 1 clinical trial to evaluate NI006 in transthyretin amyloid cardiomyopathy (ATTR cardiomyopathy).

NI006 is a human antibody directed against transthyretin amyloid (TTR amyloid) consisting of misfolded and aggregated forms of transthyretin. Neurimmune discovered NI006 by translating genetic information of human memory B cells through its Reverse Translational Medicine™ technology.

The first-in-human, placebo-controlled, multicenter Phase 1 clinical trial is designed to evaluate the safety, tolerability, pharmacokinetics and exploratory efficacy of NI006 in patients with wild-type and hereditary forms of ATTR cardiomyopathy.

"This is the fifth of our recombinant human antibody programs tested in clinical trials in human diseases linked to protein aggregation and misfolding," said Roger Nitsch, Neurimmune's CEO. "Leveraging our expertise in antibodies for Alzheimer's and Parkinson's diseases enabled the discovery of evolutionarily optimized antibodies that selectively bind and remove TTR amyloid fibrils in vivo."

NI006 is a human monocloncal antibody that binds with high affinity to TTR amyloid, but not to the physiological forms of transthyretin. In the recently initiated single and multiple ascending dose study, up to four monthly infusions of NI006 will be assessed in patients with ATTR cardiomyopathy at clinical centres in Europe.

"ATTR cardiomyopathy is characterized by the intramyocardial deposition of TTR amyloid fibrils that increase heart wall thickness and cause heart muscle stiffness leading to ventricular dysfunction," said Christoph Hock, CMO of Neurimmune. "Our goal is to develop NI006 as a novel treatment option for patients with ATTR cardiomyopathy and to improve their heart function by clearing cardiac amyloid."

About Neurimmune

Neurimmune is a biopharmaceutical company translating human immune memory into transformative 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 together with a team of researchers at the University of Zurich and licensed it to Biogen. Aducanumab, in clinical Phase 3, is a human monoclonal antibody that clears beta amyloid from the brain in patients with Alzheimer's disease. Neurimmune has used its Reverse Translational Medicine™ technology to also discover cinpanemab for Parkinson's disease, the anti-tau antibody BIIB076 for Alzheimer's disease, 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 the vectorized expression of human antibody genes.

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