CAMBRIDGE, Mass., Oct. 03, 2018 —
- Data to be presented from the BIIB092 program for progressive supranuclear palsy and BIIB054 program for Parkinson’s disease highlight Biogen’s commitment to furthering movement disorders research
- Biogen’s Phase 2 PASSPORT study of BIIB092 for PSP has completed enrollment and BIIB092 has received fast track designation by the U.S. Food and Drug Administration for PSP
Biogen Inc. (Nasdaq:BIIB) announced it will present data from its movement disorders portfolio at the upcoming International Congress of Parkinson’s Disease and Movement Disorders (MDS) in Hong Kong (Oct. 5-9, 2018). Data being presented are from Biogen’s research programs evaluating potential treatments for progressive supranuclear palsy (PSP) and Parkinson’s disease (PD) as part of its larger neurology pipeline.
“The data being presented at MDS are a testament to Biogen’s commitment to its goal of delivering innovative therapies for people living with complex, neurodegenerative conditions like PSP and PD,” said Kate Dawson, M.D., vice president of late-stage clinical development at Biogen. “PSP and PD both have significant unmet need, especially for disease modifying therapies, so we look forward to advancing the clinical development programs to help better understand these challenging conditions.”
Biogen PSP presentations will focus on safety data from the Phase 1 long-term extension study and baseline demographics from the Phase 2 PASSPORT study. The company’s BIIB092 program has recently met milestones, including recruitment completion for the Phase 2 PASSPORT study and fast track designation by the U.S. Food and Drug Administration for PSP. PSP is a rare neurodegenerative disease, considered to be a primary tauopathy, characterized by rapidly progressing physical impairments, such as difficulty speaking, swallowing and walking, as well as cognitive/behavioral impairments, such as apathy and dementia.
PD presentations will feature an overview of the design of the BIIB054 SPARK Phase 2 study, which is the most advanced program in Biogen’s PD pipeline. PD is the second most common neurodegenerative disease after Alzheimer’s disease. Motor symptoms of PD include bradykinesia, muscular rigidity, rest tremor and postural and gait impairment.1
Biogen’s presentations highlight:
- Safety analysis of an open-label extension study of BIIB092 in participants with PSP – POSTER, Abstract #43 – Saturday, Oct. 6, 13:45 – 15:15 HKT
- PASSPORT, an ongoing Phase 2 study in patients with PSP– baseline characteristics – POSTER, Abstract #8 – Saturday, Oct. 6, 13:45 – 15:15 HKT
- Prevalence and characteristics of patients with progressive supranuclear palsy (PSP) in US health insurance claims data –POSTER, Abstract #795 – Sunday, Oct. 7, 13:45 – 15:15 HKT
- Burden of progressive supranuclear palsy: a systematic literature review – POSTER, Abstract #921 – Sunday, Oct. 7,13:45 – 15:15 HKT
- Effect of PD medication on disease progression as measured by rate of change in MDS_UPDRS and DaT SBR in PPMI study – POSTER, Abstract #11– Saturday, Oct. 6, 13:45 – 15:15 HKT
- Design and status of the BIIB054 SPARK trial – POSTER, Abstract #39 – Saturday, Oct. 6, 13:45 – 15:15 HKT
- Quantitative assessment of appendicular bradykinesia in PD using wearable sensors – POSTER, Abstract #1131 – Sunday, Oct. 7, 13:45 – 15:15 HKT
- Effects of LDOPA on quantitative gait parameters measured with wearable sensors – POSTER, Abstract #1137 – Sunday, Oct. 7, 13:45 – 15:15 HKT
About Biogen 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. One of the world’s first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp, and today 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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Biogen Safe Harbor This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, about the Phase 1 long-term extension study and Phase 2 study of BIIB092 and the Phase 2 study of BIIB054; the potential clinical effects of BIIB092 and BIIB054; the potential benefits, safety and efficacy of BIIB092 and BIIB054; the identification and treatment of PSP; the potential of Biogen’s commercial business and pipeline programs, including BIIB092 and BIIB054; and risks and uncertainties associated with drug development and commercialization. These statements may be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will” and other words and terms of similar meaning. 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. You should not place undue reliance on these statements or the scientific data presented.
These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation uncertainty of success in the development and potential commercialization of BIIB092 and/or BIIB054; the risk that we may not fully enroll our clinical trials or enrollment will take longer than expected; unexpected concerns may arise from additional data, analysis or results obtained during our clinical trials; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of our drug candidates, including BIIB092 and/or BIIB054; the occurrence of adverse safety events; unexpected costs or delays; we may encounter other unexpected hurdles; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; and product liability claims. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in our most recent annual or quarterly report and in other reports we have filed with the Securities and Exchange Commission. These statements are based on our current beliefs and expectations and speak only as of the date of this press release. We do not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
1 Kalia LV, Lang AE. Parkinson’s disease, Lancet. 2015 Aug 29;386(9996):896-912
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