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Topline Results from Tofersen Phase 3 Study and its Open Label Extension in SOD1-ALS to be Presented at the American Neurological Association Annual Meeting

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Biogen Inc. (NASDAQ: BIIB) announced the upcoming presentation of topline results from its pivotal Phase 3 VALOR study of tofersen (BIIB067) at the American Neurological Association (ANA) virtual meeting from October 17-19, 2021. The study focuses on the efficacy and safety of tofersen in patients with superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS). Tofersen aims to reduce SOD1 protein production by degrading SOD1 mRNA. The study's findings, presented by Dr. Timothy Miller, could significantly impact treatment strategies for SOD1-ALS.

Positive
  • Upcoming presentation of pivotal Phase 3 VALOR study results.
  • Tofersen represents a potential breakthrough in treating SOD1-ALS.
Negative
  • None.

CAMBRIDGE, Mass., Oct. 14, 2021 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced topline results from its pivotal Phase 3 VALOR study of tofersen (BIIB067), an investigational antisense oligonucleotide (ASO) drug being evaluated for people with superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS), will be presented at the upcoming American Neurological Association (ANA) 2021 virtual meeting, October 17-19, 2021.

ANA Presentation Details:
Sunday, October 17, 2021, 4:20 p.m. ET – Results from the Phase 3 VALOR study and its open-label extension: evaluating the clinical efficacy and safety of tofersen in adults with ALS and confirmed SOD1 mutation, presented by Timothy Miller, M.D., Ph.D., principal investigator of VALOR and ALS Center Director at Washington University School of Medicine, St. Louis.

To access the presentation, please go to the Investors section of Biogen’s website at investors.biogen.com. Following the event, an archived version will be available on the website.

About Tofersen
Tofersen is an antisense asset being evaluated for the potential treatment of SOD1-ALS. Tofersen binds to SOD1 mRNA, allowing for its degradation by RNase-H in an effort to reduce synthesis of SOD1 protein production. Biogen licensed tofersen from Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) under a collaborative development and license agreement.

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 as well as related therapeutic adjacencies. 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. Today Biogen has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, commercializes biosimilars of advanced biologics and is focused on advancing research programs in multiple sclerosis and neuroimmunology, Alzheimer’s disease and dementia, neuromuscular disorders, movement disorders, ophthalmology, immunology, neurocognitive disorders, acute neurology and pain.

We routinely post information that may be important to investors on our website at www.biogen.com. To learn more, please visit www.biogen.com and follow us on social media – Twitter, LinkedIn, Facebook, YouTube.

MEDIA CONTACT:
Ashleigh Koss
+ 1 908 205 2572
public.affairs@biogen.com

INVESTOR CONTACT:
Mike Hencke
+1 781 464 2442
IR@biogen.com   

 


FAQ

What are the results of the Phase 3 VALOR study for tofersen (BIIB067)?

The topline results will be presented at the ANA meeting from October 17-19, 2021.

What is the purpose of the tofersen study?

The study evaluates the clinical efficacy and safety of tofersen in adults with ALS and confirmed SOD1 mutations.

When will Biogen present the VALOR study results?

The results will be presented on October 17, 2021.

What condition does tofersen target?

Tofersen targets superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS).

Who is the principal investigator of the VALOR study?

Dr. Timothy Miller is the principal investigator and ALS Center Director at Washington University School of Medicine.

How does tofersen work?

Tofersen binds to SOD1 mRNA to promote its degradation, thereby reducing SOD1 protein synthesis.

Biogen Inc.

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