Drugs / Evobrutinib
Trials 20
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2023-12-05 | EMD Serono Research & Development Institute, Inc. | Results Merck KGaA, Darmstadt, Germany Provides Update on Phase III Results for Evobrutinib in Relapsing Multiple Sclerosis emdserono.com ↗
Merck KGaA, Darmstadt, Germany, a leading science and technology company, today announced that its two Phase III EVOLUTION clinical trials (evolutionRMS 1 and evolutionRMS 2) investigating the efficacy and safety of evobrutinib did not meet their primary endpoints of reducing annualized relapse rates (ARR) in people with relapsing multiple sclerosis (RMS) compared to oral teriflunomide (0.15 vs. 0.14 in evolutionRMS 1 and 0.11 for evobrutinib and 0.11 for teriflunomide in evolutionRMS 2, p=NS in both trials). |
| 2023-10-11 | EMD Serono Research & Development Institute, Inc. | Results Evobrutinib, CNS-Penetrant BTKi, Has Shown Sustained Clinical Benefit Up to Five Years in People with RMS emdserono.com ↗
Additional patient-reported data from the study showed statistically significant and clinically meaningful improvements in mental health and vitality, which is closely related to fatigue. |
| 2023-02-23 | EMD Serono Research & Development Institute, Inc. | Results EMD Serono Highlights New Four-Year Efficacy and Safety Data for Investigational BTK Inhibitor, Evobrutinib, in RMS emdserono.com ↗
Data from the ongoing Phase II open-label extension (OLE) trial of evobrutinib showed that treatment benefits were maintained over four years, with no new safety signals. |
| 2022-10-26 | EMD Serono Research & Development Institute, Inc. | Results EMD Serono Highlights New Data for Evobrutinib, First BTKi to Demonstrate Sustained Clinical Benefit for People with RMS through Three and a Half Years of Treatment emdserono.com ↗
Phase II clinical trial data of evobrutinib demonstrated low disease activity and stable EDSS, with NfL levels, a marker of neuronal injury, remaining low in people with RMS after three and a half years of therapy |
| 2022-10-26 | EMD Serono Research & Development Institute, Inc. | Results EMD Serono Showcases Depth of MS Portfolio at ECTRIMS Supporting Commitment to Advancing MS Care emdserono.com ↗
Data on investigational BTK inhibitor evobrutinib demonstrate long-term disease stability in people living with relapsing MS (RMS) |
| 2022-03-31 | EMD Serono Research & Development Institute, Inc. | Results EMD Serono Shares Advances in MS Portfolio with Key Efficacy and Safety Data at AAN 2022 emdserono.com ↗
New Phase II data show evobrutinib sustained low annualized relapse rates (ARRs) and had no new safety signals at 2.5 years – the longest follow-up of any Bruton’s tyrosine kinase inhibitor in multiple sclerosis (MS) |
| 2021-10-14 | EMD Serono Research & Development Institute, Inc. | Results New Data Presented at ECTRIMS Show Evobrutinib is First BTK Inhibitor to Demonstrate a Significant Reduction in Slowly Expanding Lesions (SEL) in Patients with RMS emdserono.com ↗
Phase II post-hoc data show evobrutinib reduced acute and chronic inflammation processes in the central nervous system that may be early indicators of MS disease progression |
| 2021-04-16 | EMD Serono Research & Development Institute, Inc. | Results Evobrutinib is the First and Only BTK Inhibitor to Demonstrate Reduction of a Key Biomarker of Neuronal Damage and Inflammation in Patients with MS emdserono.com ↗
Data presented at AAN shows investigational evobrutinib significantly reduced blood neurofilament light chain (NfL) levels, which may predict future brain atrophy and disease progression, in patients with relapsing MS |
| 2020-05-23 | EMD Serono Research & Development Institute, Inc. | Results New Late-Breaking Data at EAN Indicate Evobrutinib is the First BTK Inhibitor to Report Efficacy and Safety in MS Over 108 Weeks emdserono.com ↗ |
| 2018-10-12 | Merck KGaA, Darmstadt, Germany | Results Positive Late-Breaking Phase II Data Evaluating Investigational Oral Therapy, Evobrutinib in RMS prnewswire.com ↗
The study met its primary endpoint, with evobrutinib 75mg QD (once-daily) and 75mg BID (twice-daily) significantly reducing the number of gadolinium enhancing T1 (T1 Gd+) lesions measured at weeks 12, 16, 20 and 24 in comparison to patients receiving placebo. |
| 2018-03-07 | Merck KGaA, Darmstadt, Germany | Results Merck KGaA, Darmstadt, Germany, Announces Positive Phase IIB Results for Evobrutinib in Relapsing Multiple Sclerosis prnewswire.com ↗
The study has met its primary endpoint, demonstrating that evobrutinib resulted in a clinically meaningful reduction of gadolinium enhancing T1 lesions measured at weeks 12, 16, 20 and 24 in comparison to patients receiving placebo. |
All press releases naming this drug 12 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 22 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Evobrutinib | “The purpose of this study is to evaluate the pharmacokinetic (PK), pharmacodynamic (PD), and safety and tolerability of evobrutinib after oral administration of immediate...” NCT05245396 ↗12“Relative Bioavailability of Evobrutinib Tablet Batches” NCT07214922 ↗ |
| Known as | M2951 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02975336 ↗ |
| Known as | MSC2364447C | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02537028 ↗ |
| Action | Inhibit | “a Bruton's tyrosine kinase inhibitor (BTKi)” PMID 36418156 ↗ Nov 2022 |
| Modality | Small molecule | — CHEMBL4072833 ↗ |
| Route | Oral | “Subjects will be administered with MSC2364447C 25 milligrams orally once daily for 4 weeks.” NCT02537028 ↗ |
| Target | BTK | “a Bruton's tyrosine kinase inhibitor (BTKi)” PMID 36418156 ↗ Nov 2022 |