- Late-breaking Part III FENtrepid outcomes introduced at ACTRIMS present investigational fenebrutinib met its main endpoint of non-inferiority in comparison with the present normal of care, OCREVUS, in decreasing incapacity development in PPMS
- Fenebrutinib numerically lowered the danger of incapacity development by 12% in comparison with OCREVUS as early as 24 weeks; extra evaluation confirmed potential profit in higher limb perform
- Fenebrutinib has the potential to grow to be first-in-class in a number of sclerosis, as an oral, brain-penetrant BTK inhibitor for PPMS and relapsing a number of sclerosis (RMS)
- Regulatory submission for fenebrutinib in each PPMS and RMS is deliberate following the Part III FENhance 1 readout, anticipated mid first half of 2026
Basel, 07 February 2026 – Roche (SIX: RO, ROG; OTCQX: RHHBY) introduced at this time new late-breaking information from the Part III FENtrepid research displaying the investigational Bruton’s tyrosine kinase (BTK) inhibitor fenebrutinib met its main endpoint of non-inferiority in comparison with OCREVUS (ocrelizumab) in decreasing incapacity development in sufferers with main progressive a number of sclerosis (PPMS). Fenebrutinib confirmed a 12% discount within the danger of incapacity development in comparison with OCREVUS, the one accredited drugs for PPMS, as measured by the point to onset of 12-week composite confirmed incapacity development (cCDP12) (hazard ratio [HR] 0.88; 95% confidence interval [CI]: 0.75, 1.03) with curves separating as early as 24 weeks. A constant remedy impact on cCDP12 was noticed throughout affected person subgroups and for the complete remedy period.
The cCDP12 main endpoint included the confirmed incapacity development (CDP) primarily based on the Expanded Incapacity Standing Scale (EDSS) for purposeful incapacity, the timed 25-foot stroll (T25FW) for strolling pace and the nine-hole peg take a look at (9HPT) for higher limb perform. The strongest remedy impact was noticed on the danger of worsening on the 9HPT by 26% (HR 0.74; 95% CI: 0.56, 0.98) in comparison with OCREVUS.
“Fenebrutinib confirmed a constant scientific profit as early as week 24, notably in higher limb perform, which is important for preserving independence and day by day functioning,” stated Professor Amit Bar-Or, Director of the Heart for Neuroinflammation and Neurotherapeutics, Perelman College of Drugs, College of Pennsylvania. “With just one disease-modifying remedy out there for folks with PPMS, fenebrutinib has the potential to be a high-efficacy, oral remedy choice that acts instantly within the mind, focusing on progressive biology, and should sluggish incapacity.”
“Fenebrutinib represents the primary potential scientific breakthrough for the PPMS group in over a decade, demonstrating a significant scientific profit in decreasing incapacity development in a research versus the one accredited remedy in PPMS,” stated Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of World Product Improvement. “We stay up for advancing our regulatory submission following the upcoming readout of our second pivotal RMS research, FENhance 1.”
Moreover, a post-hoc evaluation confirmed that fenebrutinib was superior to OCREVUS on a composite endpoint together with two of the three parts of cCDP12 (EDSS and 9HPT), with a 22% discount in danger (HR 0.78; 95% CI: 0.64, 0.95).
Hostile occasions (AEs) generally (≥10%) noticed within the fenebrutinib group had been corresponding to OCREVUS: infections (67.0% vs 70.9%), nausea (12.0% vs 7.1%) and haemorrhage (10.2% vs 8.1%). Transient and reversible liver enzyme elevations had been noticed extra usually within the fenebrutinib group (13.3% vs 2.9%), and all instances resolved after research drug discontinuation. No Hy’s legislation instances (an indicator for potential extreme liver damage) had been noticed. Critical AEs had been reported in 19.1% of sufferers receiving fenebrutinib (vs 18.9% on OCREVUS) and led to 4.3% withdrawing from remedy (vs 3.0% on OCREVUS). Within the FENtrepid research there have been 1.4% deadly instances within the fenebrutinib arm vs 0.2% within the OCREVUS arm, all of which had been assessed as unrelated to the research remedy by the investigators and no sample was noticed in timing or trigger. Epidemiological research have proven that fatality charges are increased in folks residing with MS in comparison with the final inhabitants.1-4
Outcomes had been shared at this time as a late-breaking oral presentation on the Americas Committee for Therapy and Analysis in A number of Sclerosis (ACTRIMS) Discussion board 2026 in San Diego, California. These information observe Roche’s announcement in November 2025 that the FENtrepid research and the primary of two Part III relapsing a number of sclerosis (RMS) research (FENhance 2) met their main endpoints. As soon as the second RMS research (FENhance 1) has learn out, which is anticipated within the first half of 2026, information from all Part III fenebrutinib trials will probably be submitted to regulatory authorities.
Concerning the FENtrepid research
FENtrepid is a Part III multicentre, randomised, double-blind, double-dummy, parallel-group research to guage the efficacy and security of fenebrutinib in contrast with OCREVUS in 985 grownup sufferers with main progressive a number of sclerosis (PPMS). Eligible members had been randomised 1:1 to obtain remedy with both day by day oral fenebrutinib (and placebo matched to intravenous [IV] OCREVUS) or IV OCREVUS (and placebo matched to oral fenebrutinib) for not less than 120 weeks.
The first endpoint is the time to onset of 12-week composite confirmed incapacity development (cCDP12). The cCDP incorporates three measures of incapacity – whole purposeful incapacity measured by the confirmed incapacity development (CDP) primarily based on the Expanded Incapacity Standing Scale (EDSS), strolling pace measured by the timed 25-foot stroll (T25FW) and higher limb perform measured by the nine-hole peg take a look at (9HPT). This complete composite endpoint gives larger sensitivity than the EDSS alone, capturing extra facets of incapacity and sometimes earlier. Key secondary endpoints embody the time to onset of 24-week composite confirmed incapacity development (cCDP24), 12-week confirmed incapacity development (CDP12) and 24-week confirmed incapacity development (CDP24).
Following the double-blind remedy interval, sufferers have the choice to enter an open-label extension (OLE) section, during which all sufferers obtain remedy with fenebrutinib.
About fenebrutinib
Fenebrutinib is an investigational oral, central nervous system (CNS)-penetrant, reversible and non-covalent Bruton’s tyrosine kinase (BTK) inhibitor with an optimised pharmacokinetics (PK) profile and excessive efficiency. Whereas most present BTK inhibitors are covalent and irreversible, that means they type a everlasting chemical bond with the enzyme, fenebrutinib binds after which ultimately releases the enzyme. These design options could assist restrict off-target results.
Fenebrutinib has a selectivity for BTK 130 instances larger than different kinases which signifies that it could actually bind to its meant BTK goal with out interfering in different kinases. Fenebrutinib can act all through the physique and in addition cross the blood-brain barrier into the CNS to focus on persistent irritation. It’s uniquely designed to focus on relapsing and progressive biology by inhibiting cells within the immune system often known as B cells and microglia. Focusing on B cells helps management the acute irritation that causes relapses, whereas focusing on microglia contained in the mind addresses the persistent injury that’s thought to drive long-term incapacity development.
The fenebrutinib Part III programme consists of two equally designed trials in relapsing a number of sclerosis (RMS) (FENhance 1 and a couple of) with lively comparator teriflunomide and the one trial in main progressive a number of sclerosis (PPMS) (FENtrepid) during which a BTK inhibitor is being evaluated in opposition to OCREVUS.
So far, greater than 2,700 sufferers and wholesome volunteers have been handled with fenebrutinib in Part I, II and III scientific programmes throughout a number of ailments, together with a number of sclerosis and different autoimmune problems.
About a number of sclerosis
A number of sclerosis is a persistent illness that impacts greater than 2.9 million folks worldwide. Individuals with all types of a number of sclerosis expertise illness development from the start of their illness. Due to this fact, an necessary aim of treating a number of sclerosis is to sluggish, cease and ideally stop development as early as attainable.
Roughly 85% of individuals with a number of sclerosis have a relapsing type of the illness (RMS) characterised by relapses and in addition worsening incapacity over time. Main progressive a number of sclerosis (PPMS) is a debilitating type of the illness marked by steadily worsening signs however sometimes with out distinct relapses or intervals of remission. Roughly 15% of individuals with a number of sclerosis are recognized with the first progressive type of the illness. Till the FDA approval of OCREVUS®, there had been no FDA-approved therapies for PPMS and OCREVUS remains to be the one accredited remedy for PPMS.
About Roche in Neuroscience
Neuroscience is a significant focus of analysis and growth at Roche. Our aim is to pursue groundbreaking science to develop new therapies that assist enhance the lives of individuals with persistent and probably devastating ailments.
Roche is investigating greater than a dozen medicines for neurological problems, together with a number of sclerosis, spinal muscular atrophy, neuromyelitis optica spectrum dysfunction, Alzheimer’s illness, Huntington’s illness, Parkinson’s illness and Duchenne muscular dystrophy. Along with our companions, we’re dedicated to pushing the boundaries of scientific understanding to unravel a number of the most troublesome challenges in neuroscience at this time.
About Roche
Based in 1896 in Basel, Switzerland, as one of many first industrial producers of branded medicines, Roche has grown into the world’s largest biotechnology firm and the worldwide chief in in-vitro diagnostics. The corporate pursues scientific excellence to find and develop medicines and diagnostics for bettering and saving the lives of individuals world wide. We’re a pioneer in personalised healthcare and wish to additional remodel how healthcare is delivered to have a fair larger affect. To offer the very best look after every individual we companion with many stakeholders and mix our strengths in Diagnostics and Pharma with information insights from the scientific observe.
For over 125 years, sustainability has been an integral a part of Roche’s enterprise. As a science-driven firm, our biggest contribution to society is creating revolutionary medicines and diagnostics that assist folks stay more healthy lives. Roche is dedicated to the Science Based mostly Targets initiative and the Sustainable Markets Initiative to realize internet zero by 2045.
Genentech, in america, is an entirely owned member of the Roche Group. Roche is almost all shareholder in Chugai Pharmaceutical, Japan.
For extra data, please go to www.roche.com.
All logos used or talked about on this launch are protected by legislation.
References
[1] Manouchehrinia A, et al. Mortality in a number of sclerosis: meta-analysis of standardised mortality ratios. J Neurol Neurosurg Psychiatry. 2016;87:324–331.
[2] Smyrke N, et al. Standardized mortality ratios in a number of sclerosis: Systematic evaluate with meta-analysis. Acta Neurol Scand. 2021;00:1–11.
[3] Scalfari A, et al. Mortality in sufferers with a number of sclerosis. Neurology. 2013;81:184–192.
[4] Kingwell E, et al. Causes that Contribute to the Extra Mortality Danger in A number of Sclerosis: A Inhabitants-Based mostly Examine. Neuroepidemiology. 2020;54:131–139.
Roche World Media Relations
Telephone: +41 61 688 8888 / e-mail: media.relations@roche.com
| Hans Bushes, PhD Telephone: +41 79 407 72 58 |
Nathalie Altermatt Telephone: +41 79 771 05 25 |
| Lorena Corfas Telephone: +41 79 568 24 95 |
Simon Goldsborough Telephone: +44 797 32 72 915 |
| Karsten Kleine Telephone: +41 79 461 86 83 |
Kirti Pandey Telephone: +49 172 6367262 |
| Yvette Petillon Telephone: +41 79 961 92 50 |
Dr Rebekka Schnell Telephone: +41 79 205 27 03 |
Roche Investor Relations
Investor Relations North America
- Media Investor Launch ACTRIMS FENtrepid English
Source link
#Roches #fenebrutinib #investigational #drugs #decade #reduces #incapacity #development #main #progressive #a number of #sclerosis #PPMS
