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Sanofi to present Phase 2 detailed results of its brain-penetrant BTK inhibitor in relapsing multiple sclerosis

Sanofi to present Phase 2 detailed results of its brain-penetrant BTK inhibitor in relapsing multiple sclerosis

Sanofi to present Phase 2 detailed results of its brain-penetrant BTK inhibitor in relapsing multiple sclerosis

*Sanofi to host virtual scientific session April 23 from 8:00-9:00 am EST/ 2:00 – 3:00 pm CET



PARIS – April 17, 2020 – Sanofi will host a scientific session to present detailed data from their Phase 2b trial evaluating its investigational BTK (Bruton’s tyrosine kinase) inhibitor (SAR442168), an oral, brain-penetrant, selective small molecule. In February, that the study’s primary endpoint was met, demonstrating that the BTK inhibitor significantly reduced disease activity associated with multiple sclerosis (MS) as measured by magnetic resonance imaging.

“During these unprecedented times we remain committed to sharing results that allow us to advance the understanding of multiple sclerosis and the impact our potential brain-penetrant BTK inhibitor could have on the lives of people living with this disease,” said John C. Reed, M.D. Ph.D. Sanofi’s Global Head of Research & Development.  “Our virtual session will provide the opportunity for an important scientific exchange and a forum for sharing the recent clinical results obtained with our brain-penetrant BTK inhibitor for multiple sclerosis.”

Sanofi is hosting this scientific session as a result of the cancellation of the live American Academy of Neurology (AAN) annual meeting due to the COVID-19 pandemic. The virtual scientific session will be held on April 23 from 8:00-9:00am EST/2:00-3:00pm CET; to register, click . No pre-registration available for the event.

Audio webcast and conference call will be open to healthcare professionals and healthcare media. It will include presentations followed by Q&A session and live access to the speakers including: Daniel Reich, MD, PhD, Senior Investigator at NIH and Chief of the Translational Neuroradiology Section in the National Institute of Neurological Disorders and Stroke; Ross Gruber, PhD, Principal Scientist at Sanofi Genzyme; and Anthony Traboulsee, MD, Professor and Research Chair of the MS Society of Canada at the University of British Columbia in Vancouver, Canada

Topics to be highlighted which were planned to be presented at AAN:

  • BTK inhibitor mechanism of action and preclinical data
  • Phase 2b trial design
  • Phase 2b efficacy and safety results

            

In the US and Europe, there are approximately 1.2 million people diagnosed with MS, an unpredictable, chronic disease that attacks the central nervous system. Despite current treatments, many people with MS continue to accumulate disability, and one in four suffer from progressive forms of the disease with limited or no treatments available.

The efficacy and safety of Sanofi’s BTK inhibitor has not been confirmed by any regulatory authority.

 



About Sanofi

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.



 



With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.



 



Sanofi, Empowering Life



 





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Sanofi Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi’s ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the  ultimate outcome of such litigation,  trends in exchange rates and prevailing interest rates, volatile economic and market conditions, the impact of global disruptions, including pandemics, cost containment initiatives and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2019. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.



 

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