Biogen (Nasdaq: BIIB) will present data from its portfolio of investigational therapies for people with neurodegenerative diseases at the Advances in Alzheimer’s and Parkinson’s Therapies (AAT-AD/PD) Focus Meeting in Torino, Italy (March 15-18, 2018). AAT-AD/PD is a new joint meeting between the International Geneva/Springfield Symposium on Advances in Alzheimer’s Therapy and AD/PD™.
Alessandro Padovani M.D., Ph.D., professor of neurology and director of the Institute of Neurology at the Università degli Studi di Brescia, will open the meeting discussing the importance of early identification and treatment of Alzheimer’s disease. His discussion will include Centiloid, a method used to standardize the aducanumab Phase 1b study amyloid PET results as previously measured by the composite Standardized Uptake Value Ratio (SUVR). At 54 weeks, the treatment group receiving the highest dose of aducanumab (10 mg/kg) experienced a 69% reduction from baseline in amyloid plaque as observed on the Centiloid Conversion scale (P<0.001 versus placebo). There was no change from baseline in the placebo arm.
In the Phase 1b long-term extension (LTE), the most commonly reported adverse events were headache, fall, and amyloid-related imaging abnormalities (ARIA). Of the 185 patients dosed with aducanumab in the Phase 1b study, 46 patients experienced ARIA-E (edema). There were no new cases of ARIA-E in patients who continued on the same dose of aducanumab.
“Biogen is working to solve some of medicine’s greatest challenges among the most complex, devastating neurodegenerative diseases,” said Alfred Sandrock, M.D., Ph.D., executive vice president and chief medical officer at Biogen. “As pioneers in neuroscience with 40 years of expertise we remain committed to tackling areas of high unmet medical need such as Alzheimer’s disease and movement disorders including Parkinson’s disease and progressive supranuclear palsy.”
The planned Alzheimer’s disease presentations include:
- The Importance of Early Identification and Treatment of Alzheimer’s disease. Plenary Session; March 15, 2018, 13:00 – 13:30 CET.
- The early diagnosis of Alzheimer’s disease: It’s about time. Biogen Sponsored Symposium; March 16, 2018, 11:45 – 13:25 CET.
- Aducanumab interim analysis from PRIME: A randomized, double-blind, placebo-controlled Phase 1B study in patients with prodromal or mild Alzheimer’s disease. Symposium Session 13; March 16, 2018, 16:45 – 17:05 CET.
The planned movement disorders presentations include:
- Neuromelanin-sensitive MRI as a potential biomarker for Parkinson’s disease. Poster 114; March 15, 2018, 8:00 – 18:00 CET.
- Wearable sensors for quantitative gait characteristics in clinical trials of Parkinson’s disease. Poster 129; March 15, 2018, 8:00 – 18:00 CET.
- Efficacy and safety of BIIB092 in patients with progressive supranuclear palsy: PASSPORT Phase 2 study design. Symposium Session 18; March 17, 2018, 9:45 – 10:05 CET.
Biogen will participate in two panel discussions:
- Forum discussion 2 – AD Phase III Clinical Trials. Panel Discussion; March 16, 2018, 14:25 – 15:25 CET.
- Forum on novel approaches to disease-modifying therapies of Parkinson’s disease (PD) and Lewy Body Disease (LBD). Panel Discussion; March 17, 2018, 14:00 – 15:00 CET.
The “Importance of Early Identification and Treatment of Alzheimer’s disease” Plenary Session will be webcast live. To access the live webcast, please visit the Investors section of Biogen’s website at www.biogen.com/investors. An archived version of the webcast will be available following the presentation.
At Biogen, our mission is clear: we are pioneers in neuroscience. Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. Founded in 1978 as one of the world’s first global biotechnology companies by Charles Weissman, Heinz Schaller, Kenneth Murray, and Nobel Prize winners Walter Gilbert and Phillip Sharp, today Biogen has the leading portfolio of medicines to treat multiple sclerosis; has introduced the first and only approved treatment for spinal muscular atrophy; and is focused on advancing neuroscience research programs in Alzheimer’s disease and dementia, multiple sclerosis and neuroimmunology, movement disorders, neuromuscular disorders, pain, ophthalmology, neuropsychiatry, and acute neurology. Biogen also manufactures and commercializes biosimilars of advanced biologics.
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This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 about additional results from the Phase 1b study of aducanumab, the potential clinical effects of aducanumab and/or BIIB092, the identification and treatment of Alzheimer’s disease as well as clinical studies on Parkinson’s disease and progressive supranuclear palsy. These statements may be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “possible,” “potential,” “will” and other words and terms of similar meaning, and are based on our current beliefs and expectations. You should not place undue reliance on these statements or the scientific data presented. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval.
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