GlobeNewswire by notified

Roche’s BTK inhibitor fenebrutinib significantly reduced brain lesions in people with relapsing forms of multiple sclerosis

Share
  • Fenebrutinib is an investigational, potent and highly selective oral Bruton’s tyrosine kinase (BTK) inhibitor, the only reversible BTK inhibitor currently in Phase III multiple sclerosis (MS) trials
  • Phase II study met its primary and secondary endpoints by reducing the total number of new gadolinium-enhancing T1 brain lesions and significantly reducing the total number of new or enlarging T2 brain lesions compared to placebo
  • The safety profile of fenebrutinib was consistent with previous and ongoing clinical trials across more than 2,400 people to date

Basel, 17 May 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive results from the Phase II FENopta study evaluating investigational oral fenebrutinib in adults with relapsing forms of multiple sclerosis (RMS). The study met its primary and secondary endpoints, showing oral fenebrutinib significantly reduced magnetic resonance imaging (MRI) markers of MS disease activity in the brain compared to placebo. Additionally, pre-clinical data have shown fenebrutinib to be potent and highly selective, and it is the only reversible inhibitor currently in Phase III trials for MS.

“I am encouraged by this clinical data for fenebrutinib, which is important news for people living with MS,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Fenebrutinib’s mechanism of action which can inhibit both B cells and microglia, has the potential to both reduce MS disease activity, such as relapses, and also impact disease progression.’’

Fenebrutinib significantly reduced the total number of new gadolinium-enhancing T1 brain lesions compared to placebo, the primary endpoint of the trial (p=0.0022). Additionally, fenebrutinib significantly reduced the total number of new or enlarging T2 brain lesions compared to placebo, a secondary endpoint. Furthermore, a higher proportion of patients treated with fenebrutinib were free from any new gadolinium-enhancing T1 brain lesions and new or enlarging T2-weighted brain lesions compared to placebo. T1 lesions, as measured by MRI, are a marker of active inflammation and T2 lesions represent the amount of disease burden or lesion load.

The safety profile of fenebrutinib was consistent with previous and ongoing fenebrutinib clinical trials across more than 2,400 people to date. There were no new safety concerns identified in the FENopta study.

Detailed results will be shared at an upcoming medical meeting. The Phase III fenebrutinib clinical trial programme in RMS and primary progressive MS (PPMS) is ongoing.

About fenebrutinib
Fenebrutinib is an investigational oral, reversible and non-covalent Bruton’s tyrosine kinase (BTK) inhibitor that blocks the function of BTK. BTK, also known as tyrosine-protein kinase BTK, is an enzyme that regulates B-cell development and activation and is also involved in the activation of innate immune system myeloid lineage cells, such as macrophages and microglia. Pre-clinical data have shown fenebrutinib to be potent and highly selective, and it is the only reversible inhibitor currently in Phase III trials for MS. Fenebrutinib has been shown to be 130 times more selective for BTK vs. other kinases. These design features may be important as the high selectivity and reversibility can potentially reduce off-target effects of a molecule and contribute to long-term safety outcomes.

Fenebrutinib is a dual inhibitor of both B-cell and microglia activation. This dual inhibition has the potential to reduce both MS disease activity and progression, thereby addressing the key unmet medical need in people living with MS. The Phase III programme includes two identical trials in RMS (FENhance 1 & 2) with an active teriflunomide comparator and one trial in primary progressive MS (PPMS) (FENtrepid) in which fenebrutinib is being evaluated against OCREVUS® (ocrelizumab). To date, more than 2,400 patients and healthy volunteers have been treated with fenebrutinib in Phase I, II and III clinical programmes across multiple diseases, including MS and other autoimmune disorders.

About the FENoptastudy
The FENopta study is a global Phase II, randomised, double-blind, placebo-controlled 12-week study to investigate the efficacy, safety and pharmacokinetics of fenebrutinib in 109 adults aged 18-55 years with RMS. The primary endpoint is the total number of new gadolinium-enhancing T1 lesions as measured by MRI scans of the brain at 4, 8 and 12 weeks. Secondary endpoints include the number of new or enlarging T2-weighted lesions as measured by MRI scans of the brain at 4, 8 and 12 weeks, and the proportion of patients free from any new gadolinium-enhancing T1 lesions and new or enlarging T2-weighted lesions as measured by MRI scans of the brain at 4, 8 and 12 weeks. The goal of the FENopta study is to characterise the effect of fenebrutinib on MRI and soluble biomarkers of disease activity and progression, and it includes an optional substudy to measure cerebrospinal fluid biomarkers of neuronal injury. Patients who complete the double-blind period are eligible for an open-label extension study. 

About multiple sclerosis
Multiple sclerosis (MS) is a chronic disease that affects more than 2.8 million people worldwide. MS occurs when the immune system abnormally attacks the insulation and support around nerve cells (myelin sheath) in the central nervous system (brain, spinal cord and optic nerves), causing inflammation and consequent damage. This damage can cause a wide range of symptoms, including muscle weakness, fatigue and difficulty seeing, and may eventually lead to disability. Most people with MS experience their first symptom between 20 and 40 years of age, making the disease the leading cause of non-traumatic disability in younger adults.

People with all forms of MS experience disease progression – permanent loss of nerve cells in the central nervous system – from the beginning of their disease even if their clinical symptoms aren’t apparent or don’t appear to be getting worse. Delays in diagnosis and treatment can negatively impact people with MS, in terms of their physical and mental health, and contribute to the negative financial impact on the individual and society. An important goal of treating MS is to slow, stop and ideally prevent disease activity and progression as early as possible.

Relapsing-remitting MS (RRMS) is the most common form of the disease and is characterised by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. Approximately 85% of people with MS are initially diagnosed with RRMS. The majority of people who are diagnosed with RRMS will eventually transition to secondary progressive MS (SPMS), in which they experience steadily worsening disability over time. Relapsing forms of MS (RMS) include people with RRMS and people with SPMS who continue to experience relapses. Primary progressive MS (PPMS) is a debilitating form of the disease marked by steadily worsening symptoms but typically without distinct relapses or periods of remission. Approximately 15% of people with MS are diagnosed with the primary progressive form of the disease. Until the FDA approval of OCREVUS, there had been no FDA-approved treatments for PPMS.

About Roche in Neurosciences
Neuroscience is a major focus of research and development at Roche. Our goal is to pursue ground-breaking science to develop new treatments that help improve the lives of people with chronic and potentially devastating diseases. Roche and Genentech are investigating more than a dozen medicines for neurological disorders, including MS, spinal muscular atrophy, neuromyelitis optica spectrum disorder, Alzheimer’s disease, Huntington’s disease, Parkinson’s disease, acute ischemic stroke, Duchenne muscular dystrophy and Angelman syndrome. Our MS franchise also includes OCREVUS, which has been approved in more than 100 countries globally with 300,000 people treated to date. Together with our partners, we are committed to pushing the boundaries of scientific understanding to solve some of the most difficult challenges in neuroscience today.

About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

In recognising our endeavor to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

Roche Group Media Relations

Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Hans Trees, PhD
Phone: +41 79 407 72 58
Nathalie Altermatt
Phone: +41 79 771 05 25

KarstenKleine
Phone: +41 79 461 86 83
Nina Mählitz
Phone: +41 79 327 54 74

Kirti Pandey
Phone: +49 172 6367262
SileiaUrech
Phone: +41 79 935 81 48

Roche Investor Relations

Dr. Bruno Eschli
Phone: +41 61 68-75284
e-mail: bruno.eschli@roche.com
Dr. Sabine Borngräber
Phone: +41 61 68-88027
e-mail: sabine.borngraeber@roche.com

Dr. Birgit Masjost
Phone: +41 61 68-84814
e-mail: birgit.masjost@roche.com
Dr. Gerard Tobin
Phone: +41 61 68-72942
e-mail: gerard.tobin@roche.com

Investor Relations North America

Loren Kalm
Phone: +1 650 225 3217
e-mail: kalm.loren@gene.com

Attachment

To view this piece of content from www.globenewswire.com, please give your consent at the top of this page.
To view this piece of content from ml-eu.globenewswire.com, please give your consent at the top of this page.

About GlobeNewswire by notified

GlobeNewswire by notified
GlobeNewswire by notified
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://notified.com

GlobeNewswire by notified is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Subscribe to releases from GlobeNewswire by notified

Subscribe to all the latest releases from GlobeNewswire by notified by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire by notified

Nyxoah Strengthens its Executive Leadership Team28.11.2023 22:30:00 CET | Press release

Nyxoah Strengthens its Executive Leadership Team Francis Kim appointed as Chief Regulatory and Quality Officer Mont-Saint-Guibert, Belgium – November 28, 2023, 10:30pm CET / 4:30pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today announced the appointment of Francis Kim as Chief Regulatory and Quality Officer. Francis will be leading Nyxoah’s Global Regulatory and Quality departments. Francis is a highly experienced global regulatory and quality executive in the healthcare industry, having spent more than 25 years in the medical device and life sciences sector. Francis has led Regulatory and Quality departments at Medtronic, Philips, and other companies, including introducing several innovative products and therapies to the market. “Nyxoah is entering the most exciting time in the Company’s history, with data fro

Alvotech Reports Financial Results for First Nine Months of 2023 and Provides Business Update28.11.2023 22:15:00 CET | Press release

Product revenue for the nine months of 2023 increased to $29.8 million, compared to $11.1 million for the same period in 2022Marketing authorization was received for AVT04 in Canada and Japan, the first for a biosimilar to Stelara® (ustekinumab)The European Medicines Agency proposed market authorization for AVT04 in the 30 member states of the European Economic Area, pending a final decision by the European CommissionApprovability of AVT02 and AVT04 in the U.S. now pending satisfactory US Food and Drug Administration (FDA) inspection of Alvotech’s facility in Iceland, currently expected on January 10 – 19, 2024Management will conduct a business update conference call and live webcast on Thursday November 29, 2023, at 8:00 am ET (13:00 pm GMT) Alvotech (NASDAQ: ALVO, or the “Company”), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today reported unaudited financial results for the first nine months of 2023 and pr

RÄTTELSE: Saknad MAR-etikett i tidigare pressmeddelande – ”Anoto ingår ett avtal för 1,1 miljoner USD avseende försäljning av pennor och treåriga mjukvarulicenser med Deutsche Telekom”28.11.2023 19:15:00 CET | Pressemelding

Anoto Group AB (publ) utfärdar en rättelse av pressmeddelandet som publicerades tidigare idag. Rättelsen avser att pressmeddelandet saknade MAR-etikett med hänvisning till EU:s marknadsmissbruksförordning (MAR). Följande information skulle ha varit med i pressmeddelandet: ”Denna information är sådan information som Anoto Group AB (publ) är skyldigt att offentliggöra enligt EU:s marknadsmissbruksförordning. Informationen lämnades genom ovanstående kontaktpersons försorg för offentliggörande den 28 november 2023, kl. 08:00 CEST.” Nedan publiceras det korrekta pressmeddelandet i sin helhet. Stockholm den 28 november 2023 – Anoto Group AB (publ) ("Anoto" eller "Bolaget") meddelar idag att bolaget har tecknat ett upphandlingsavtal som avser försäljning av nya pennor, samt ett treårigt mjukvarulicensavtal med Deutsche Telekom AG (”Deutsche Telekom”). Deutsche Telekom är en av de äldsta kunderna inom Anotos affärssegment Forms och avtalet innebär att ramverket inom vilket Anoto och Deutsche T

CORRECTION: Missing MAR label in previous press release – “Anoto enters into a USD 1.1 million agreement for the sale of pens and three-year software licenses with Deutsche Telekom”28.11.2023 19:15:00 CET | Press release

Anoto Group AB (publ) issues a correction to the press release published earlier today. The correction refers to the fact that the press release lacked a MAR label with reference to the EU Market Abuse Regulation (MAR). The following information should have been included in the press release: ”This information constitutes inside information as Anoto Group AB (publ) is obliged to disclose under the EU Market Abuse Regulation 596/2014. The information was provided by the contact person above for publication 28 November 2023, at 08:00 CEST.” The correct press release is published in its entirety below. Stockholm, 28 November 2023 – Anoto Group AB (publ) ("Anoto" or the "Company") today announces that it has signed a procurement agreement relating to the sale of new pens, plus a new three-year software licensing agreement with Deutsche Telekom AG (“Deutsche Telekom”). Deutsche Telekom is one of the oldest customers of Anoto’s Forms business and this agreement means that the framework withi

Status for Selskabets tilgodehavende hos Portinho S.A.28.11.2023 18:30:48 CET | pressemeddelelse

28. november 2023 Meddelelse nr. 46 Status for Selskabets tilgodehavende hos Portinho S.A. Selskabets bestyrelse, valgt ind i forbindelse med at Selskabet blev omdannet til en lægemiddelvirksomhed, og direktion har i længere tid, haft en meget tæt dialog med ledelsen i Portinho S.A. om indfrielse af Selskabets tilgodehavende hos Portinho S.A., der stammer fra tiden før Selskabet blev omdannet til en lægemiddelvirksomhed. Selskabets bestyrelse og direktion har sideløbende allokeret betydelige ressourcer til at afdække, hvilke dispositioner der fra den tidligere ledelse oprindeligt førte til etableringen af tilgodehavendet samt rationalet for de efterfølgende dispositioner af den tidligere ledelse, der har indvirket på tilgodehavendets vandring. Dette arbejde pågår forsat med blandt andet bistand fra både dansk og portugisisk juridisk rådgiver. Omfanget og vurderingen af de foreløbige resultater af undersøgelsesarbejdet har ført til, at det ikke længere er Selskabets vurdering, at tilgod