ZURICH, Oct. 22, 2019 /PRNewswire/ -- Neurimmune welcomes the news that Biogen plans regulatory filing for aducanumab in Alzheimer's disease based on a new analysis of a larger data set from Phase 3 studies. Neurimmune discovered aducanumab together with a team of researchers at the University of Zurich. In 2007 Neurimmune and Biogen entered into a collaborative development and license agreement for aducanumab's development and commercialization.
"Today's news marks a substantial advancement in neuroscience. This is long-awaited progress in finding a treatment for Alzheimer's disease," said Roger Nitsch, CEO and President of Neurimmune. "For decades, patients, families and caregivers have been hoping for a scientific breakthrough leading to clinical benefit."
For the first time, large late-stage clinical study results showed that removal of amyloid in the brain can translate into clinically meaningful effects on both cognition and function in patients with Alzheimer's disease. Aducanumab - the antibody mediating amyloid removal - was among the first human antibodies Neurimmune developed through its Reverse Translational Medicine platform. This technology translates antibody-encoding genetic information obtained from human white blood cells into therapeutic antibodies.
"This continues to be a fascinating journey, from a small team of passionate scientists experimenting in the university lab, to prototyping by a startup biotech company, to creating a world-wide multidisciplinary collaboration of thousands of dedicated researchers, antibody manufacturing experts, clinical investigators and study nurses," said Roger Nitsch. "Today, we are moving a meaningful step closer toward our joint goal of delivering a treatment for Alzheimer's disease."
Neurimmune's team of scientists and clinical experts is committed to delivering innovative therapies by focusing on science-driven discoveries and early clinical development of new drug candidates. The company's entrepreneurial business model permits a high degree of independent decision making. It relies on strategic collaborations with selected industry partners for late-stage clinical development and commercialization, with those collaborations providing independent financing to fund Neurimmune's business operations and research and development engine.
Aducanumab (BIIB037) is an investigational human monoclonal antibody studied for the treatment of early Alzheimer's disease. Neurimmune licensed aducanumab to Biogen under a collaborative development and license agreement. Since 2017 Biogen and Eisai have collaborated on the development and commercialization of aducanumab globally.
EMERGE and ENGAGE were Phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel-group studies designed to evaluate the efficacy and safety of aducanumab. The primary objective of the studies was to evaluate the efficacy of monthly doses of aducanumab as compared with placebo in reducing cognitive and functional impairment as measured by changes in the CDR-SB score. Secondary objectives were to assess the effect of monthly doses of aducanumab as compared to placebo on clinical decline as measured by MMSE, ADAS-Cog 13 and ADCS-ADL-MCI.
Neurimmune is a biopharmaceutical company translating B-cell derived genetic information of human immune repertoires into transformative antibody therapeutics. Neurimmune develops drug candidates for CNS and protein aggregation diseases including Alzheimer's and Parkinson's diseases, amyotrophic lateral sclerosis, frontotemporal dementia and dementia with Lewy bodies. Neurimmune's most advanced drug candidate in clinical Phase 3 development is aducanumab for the treatment of Alzheimer's disease. Four additional drug candidates from Neurimmune are in clinical Phases 2 and 1; four further programs are in pre-clinical development, and over ten programs are in research discovery stages. Besides recombinant human monoclonal antibodies discovered through the Reverse Translational Medicine platform, Neurimmune has recently expanded the spectrum of its treatment modalities by a small chemical molecule and by programs around vectorized expression of human antibody genes.