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SCHLIEREN, SWITZERLAND – September 8, 2015 – Neurimmune announced today that the first patient has been enrolled in the global Phase 3 program for the investigational treatment aducanumab. The Phase 3 program, being conducted by Neurimmune’s collaborator, Biogen, includes the placebo-controlled studies ENGAGE and EMERGE, which are designed to evaluate the efficacy and safety of aducanumab in slowing cognitive impairment and the progression of disability in people with early Alzheimer’s disease. The commencement of the global Phase 3 studies has triggered a US$60 million milestone payment to Neurimmune, as part of a collaborative development and license agreement initiated with Biogen in 2007.
“The start of the Phase 3 studies of aducanumab for early Alzheimer’s disease marks a major milestone in the development of our company and it validates the ability of Neurimmune’s RTM™ technology platform for the generation of investigational human antibodies in one of the most difficult-to-treat human diseases,” said Professor Roger M Nitsch, MD, Co-Founder and President of Neurimmune. “We are excited about the important progress in the development of aducanumab and the opportunity to systematically determine its effects on slowing the decline of brain function in early Alzheimer’s disease. The consistent progress of our successful collaboration with Biogen, a global leader in the field of innovative therapeutics for brain diseases, is extremely pleasing.”
ENGAGE and EMERGE will assess the efficacy and safety of aducanumab in approximately 2,700 people with early Alzheimer’s disease. The studies are identical in design and eligibility criteria. Each study will be conducted in more than 20 countries in North America, Europe and Asia. For more information about the Phase 3 studies, including information about participating, visit www.clinicaltrials.gov (NCT02477800, NCT02484547).
Aducanumab is an investigational compound being developed for the treatment of Alzheimer’s disease. Aducanumab is a human recombinant monoclonal antibody derived from a de‑identified library of B cells collected from healthy elderly subjects with no signs of cognitive impairment, and cognitively impaired elderly subjects with unusually slow cognitive decline, using Neurimmune’s proprietary Reverse Translational Medicine™ (RTM™) technology platform. The RTM™ technology platform allows the generation of recombinant monoclonal human antibodies with unique therapeutic properties.
Aducanumab is thought to target aggregated forms of beta amyloid, including soluble oligomers and insoluble fibrils deposited into the amyloid plaque in the brain of AD patients. Interim Phase 1b clinical data demonstrated that aducanumab reduced amyloid from the brains of patients with early stages of Alzheimer’s disease in a dose- and time-dependent manner. The global ENGAGE and EMERGE Phase 3 studies are designed to primarily determine the effect of aducanumab on brain function in early Alzheimer’s disease.
Neurimmune out-licensed the rights for aducanumab to Biogen under a collaborative development and license agreement in 2007.
Neurimmune is a biopharmaceutical company dedicated to the development of unique classes of human therapeutic antibodies for the treatment and prevention of important human diseases with a high unmet medical need. Established in 2006 as a spin-off of the University of Zurich, Switzerland, Neurimmune has rapidly grown into a leader in the field of recombinant human monoclonal antibody therapeutics. As one of the few biotech start-ups with the ability to operate without the need for venture capital financing, within its first 9 years, Neurimmune succeeded in sustainably financing its operations by securing significant milestone payments and research funding for its programs. Neurimmune pursues an out-licensing model with its candidate human monoclonal antibody programs, and is dedicated to forging successful collaborations with world leaders in the biopharmaceutical industry.
The Neurimmune pipeline comprises high-potential biopharmaceutical drug candidates at both preclinical and clinical development stages. These therapeutic antibodies are designed to selectively target disease‑related protein epitopes, as well as specific target conformations. Examples include misfolded or post‑translationally modified forms of disease-associated proteins, such as amyloid and neurofibrillary tangles in Alzheimer’s disease, as well as physiological conformations of functional epitopes involved in enzyme activities related to major disease.
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