Roche’s BTK inhibitor fenebrutinib significantly reduced brain
lesions in people with relapsing forms of multiple sclerosis
- 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 fenebrutinibFenebrutinib
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 FENopta
studyThe 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
sclerosisMultiple 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 NeurosciencesNeuroscience 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
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