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SANOFI

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Sanofi : New long-term data reinforcing promising safety and efficacy profile of brain-penetrant tolebrutinib presented at ECTRIMS 2021 - Form 6-K

10/15/2021 | 02:12pm EST

New long-term data reinforcing promising safety and efficacy profile of brain-penetrant tolebrutinib presented at ECTRIMS 2021

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One-year results from Phase 2b extension study of brain-penetrant tolebrutinib showed 98 percent of patients remained on treatment

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After 48 weeks, mean MRI lesion activity remained low in patients who started on or switched to tolebrutinib 60mg

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Data from in vitro studies in human microglia extended previous observations that BTK-dependent inflammatory signalling can be modulated by tolebrutinib

PARIS - October 13, 2021 - Sanofi's investigational oral Bruton's tyrosine kinase (BTK) inhibitor, tolebrutinib, demonstrated favorable one-year tolerability in a Phase 2b long-term extension study (LTS) in patients with relapsing forms of multiple sclerosis (RMS). The results showed that after 48 weeks of treatment, tolebrutinib reduced multiple sclerosis (MS) disease activity as measured by magnetic resonance imaging (MRI). These data are being presented as ePosters at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) on October 13 - 15, 2021.

"Understanding the ability of a brain-penetrant therapy to slow disability accumulation has the potential to bring new hope to people suffering from difficult-to-treat MS. For nearly two decades, Sanofi has been unwavering in its efforts to accelerate research and treatment options for these patients," says Erik Wallström, M.D., Ph.D., Therapeutic Area Head, Neurology Development at Sanofi.

Ninety-eight percent (122/125) of LTS-treated patients remained in the Phase 2b extension study through Week 48. The extension study was designed to evaluate the safety of tolebrutinib and provided the opportunity to evaluate efficacy parameters and report MRI outcomes. The LTS consisted of Part A, a double-blind treatment period where patients continued the same tolebrutinib dose as administered in the dose-finding study (5, 15, 30 or 60mg/day) and Part B, where all participants switched to the 60mg tablet (5/60mg, 15/60mg, 30/60mg, 60/60mg), which is the dose being tested in the Phase 3 trials.

"Results showed favorable safety and efficacy for tolebrutinib, and nearly all patients remained enrolled at the one-year mark of the long-term extension study," says Anthony Traboulsee, M.D., Professor and Research Chair, MS Society of Canada at University of British Columbia and Phase 2b Extension Study Investigator. "Evaluating the impact BTK inhibitors can have on preventing disability accumulation is critical to addressing the needs of people living with MS. These long-term outcomes of tolebrutinib reinforce its potential as a new treatment option for MS patients."

Safety and Efficacy Outcomes:

Safety data showed continued favorable tolerability of tolebrutinib and no new safety signals. The most frequent AEs were headache (10%), COVID-19 (9%), upper respiratory tract infection (8%) and nasopharyngitis (7%).

At baseline, mean Expanded Disability Status Scale (EDSS) scores across treatment groups ranged from 2.18 to 2.65. Over 48 weeks of treatment, mean EDSS scores remained relatively stable in all treatment groups. For the 60/60mg treatment group, mean (SD) score was 2.65 (1.22) at baseline and 2.45 (1.31) at Week 48.

Patients treated with tolebrutinib 60mg experienced low annualized relapse rate (ARR) of 0.17 (95% CI: 0.10, 0.29) over the 48-week treatment period. The majority of patients (89.5%) were free of relapses during this period. The relapse rate for these patients was 1.23 in the year prior to the Phase 2b study.

MRI Outcomes:

At Week 48 of the extension study, the mean number of new Gd-enhancing lesions/scan remained low (<0.4) in the 60/60mg arm. Patients who switched to 60mg in Part B (Weeks 15-47) of the LTS experienced a reduction in Gd-enhancing lesions, approaching values observed in the 60/60mg treatment arm.

The company also presented data on the effect of tolebrutinib on human microglia that support its capacity to modulate neuroinflammatory processes directly within the central nervous system (CNS). Results from this study extended upon previous findings in mouse microglial cells to show that BTK-dependent inflammatory signalling in human microglia and tri-cultures can be modulated using tolebrutinib in vitro. This research contributes to an improved understanding of BTK signalling in neuroinflammation and how BTK inhibitors target the neuroinflammation believed to contribute to disability progression in people with MS. Tolebrutinib is the only BTK inhibitor in development for MS which has been shown to directly modulate microglia, based on publicly available information.

About tolebrutinib

Tolebrutinib is an investigational brain-penetrant Bruton's tyrosine kinase inhibitor that achieves CSF concentrations needed for targeting B lymphocytes and microglial cells, modulating neuroinflammation. Tolebrutinib is being evaluated in Phase 3 clinical trials for the treatment of relapsing forms of MS (RMS), non-relapsing secondary progressive MS (nrSPMS), and primary progressive MS (PPMS), and its safety and efficacy have not been confirmed by any regulatory authority worldwide. For more information on tolebrutinib clinical trials, please visit www.clinicaltrials.gov.

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.

Media Relations Contact

Sally Bain

Tel.: +1 (781) 264-1091

Sally.Bain@sanofi.com

Investor Relations Contacts Paris

Eva Schaefer-Jansen

Arnaud Delepine

Nathalie Pham

Investor Relations Contacts North America

Felix Lauscher

Tel.: +33 (0)1 53 77 45 45

investor.relations@sanofi.com

https://www.sanofi.com/en/investors/contact

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, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties 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, 2020. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

Disclaimer

Sanofi SA published this content on 15 October 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 15 October 2021 18:11:07 UTC.


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