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.”