A Phase I, Single-site, Open-label, Partially Randomized Study to Evaluate the Relative Bioavailability and Pharmacokinetics of Evobrutinib Following Administration of Different Formulations in Healthy Participants

The purpose of this study is to evaluate the pharmacokinetic (PK), pharmacodynamic (PD), and safety and tolerability of evobrutinib after oral administration of immediate release (IR) and modified release (MR) formulations in healthy participants.

Start Date02 Feb 2022

Sponsor / Collaborator

Merck Healthcare KGaA

[+1]

NCT05248945 / CompletedPhase 1

Phase I, Open-Label, Single-Sequence Study of the Effect of Multiple Doses of Carbamazepine on Single-Dose Evobrutinib Pharmacokinetics in Healthy Participants

The purpose of this study is to investigate the effect of multiple doses of carbamazepine on two single doses of evobrutinib pharmacokinetics (PK) in healthy participants. Study details include:
Study Duration: up to 54 days. Treatment Duration: 25 days. Visit Frequency: Participants will be resident in the Clinical Research Unit from Day 1 to Day 20 and return on Day 26 for a Safety Follow-Up visit.

Start Date13 Jan 2022

Sponsor / Collaborator

Merck Healthcare KGaA

NCT05064488 / CompletedPhase 1

A Phase I, Open-Label, Two-Part Study of the Effect of Multiple-Dose Evobrutinib on Transporter Substrates Digoxin, Metformin, Rosuvastatin, and Sumatriptan Pharmacokinetics in Healthy Participants

This study consists of 2 parts: Part 1 and 2. The purpose of this study is to evaluate the pharmacokinetic, safety and tolerability of multiple doses of evobrutinib on single doses of digoxin, metformin and rosuvastatin in Part-1 and sumatriptan in Part-2 of the study.

Start Date04 Oct 2021

Sponsor / Collaborator

Merck Healthcare KGaA

100 Clinical Results associated with Evobrutinib

100 Translational Medicine associated with Evobrutinib

100 Patents (Medical) associated with Evobrutinib

Literatures (Medical) associated with Evobrutinib

01 Dec 2024·International Immunopharmacology

Bruton’s tyrosine kinase: A promising target for treating systemic lupus erythematosus

Review

Author: Feng, Yifan ; Zhang, Tiantai ; Sun, Lan ; Zhou, Yu ; Ding, Qiaoyi

Systemic lupus erythematosus (SLE) is a chronic systemic autoimmune disorder involving multiple organs and systems. There is growing evidence that autoreactive B cells occupy a central role in the occurrence and progression of SLE due to their ability to generate pathogenic autoantibodies. Small molecule inhibitors targeting Bruton's tyrosine kinase (BTK), a crucial intracellular kinase regulating B cell development and function, emerge as a new strategy to treat SLE in recent years and are superior to biologic agents depleting B cells in many aspects. Supportive data obtained from lupus-prone mice preliminarily demonstrated the promising therapeutic potential of BTK inhibition. However, these BTK inhibitors, including elsubrutinib, evobrutinib, etc., mostly face with unsatisfactory efficacy and certain safety issues during clinical use, driving the quest for new-generation inhibitors with improved potency and higher selectivity. This paper elaborates the importance of BTK involvement in SLE pathogenesis, reviews the clinical research progress of BTK inhibitors for SLE and discusses limitations and challenges the drugs met in development, in order to contribute to a deeper understanding of disease mechanism and provide a reference for new-generation BTK inhibitor research.

01 Nov 2024·The Lancet Neurology

Safety and efficacy of evobrutinib in relapsing multiple sclerosis (evolutionRMS1 and evolutionRMS2): two multicentre, randomised, double-blind, active-controlled, phase 3 trials

Article

Author: Wiendl, Heinz ; Kappos, Ludwig ; Cree, Bruce A C ; Wolinsky, Jerry S ; Dahlke, Frank ; Hyvert, Yann ; Guehring, Hans ; Le Bolay, Claire ; Gopalakrishnan, Sathej ; Cross, Anne H ; Arnold, Douglas L ; Montalban, Xavier ; Shen Loo, Li ; Bar-Or, Amit ; Vermersch, Patrick ; Tenenbaum, Nadia ; Javor, Andrija ; Kubala Havrdova, Eva ; Tomic, Davorka ; Stuve, Olaf

BACKGROUNDEvobrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, has shown preliminary efficacy in people with relapsing multiple sclerosis in a phase 2 trial. Here, we aimed to compare the safety and efficacy of evobrutinib with the active comparator teriflunomide in people with relapsing multiple sclerosis.METHODSEvolutionRMS1 and evolutionRMS2 were two multicentre, randomised, double-blind, double-dummy, active-controlled, phase 3 trials conducted at 701 multiple sclerosis centres and neurology clinics in 52 countries. Adults aged 18-55 years with relapsing multiple sclerosis (Expanded Disability Status Scale [EDSS] score of 0·0-5·5) were included. Participants were randomly assigned (1:1) using a central interactive web response system to receive either evobrutinib (45 mg twice per day with placebo once per day) or teriflunomide (14 mg once per day with placebo twice per day), all taken orally and in an unfasted state, with randomisation stratified by geographical region and baseline EDSS. All study staff and participants were masked to the study interventions. The primary endpoint for each study was annualised relapse rate based on adjudicated qualified relapses up to 156 weeks, assessed in the full analysis set (defined as all randomly assigned participants) with a negative binomial model. These studies are registered with ClinicalTrials.gov (NCT04338022 for evolutionRMS1 and NCT04338061 for evolutionRMS2, both are terminated).FINDINGSThe primary analysis was done using data for 2290 randomly assigned participants collected from June 12, 2020, to Oct 2, 2023. 1124 participants were included in the full analysis set in evolutionRMS1 (560 in the evobrutinib group and 564 in the teriflunomide group) and 1166 in evolutionRMS2 (583 in each group). 751 (66·8%) participants were female and 373 (33·1%) were male in evolutionRMS1, whereas 783 (67·2%) were female and 383 (32·8%) were male in evolutionRMS2. Annualised relapse rate was 0·15 (95% CI 0·12-0·18 with evobrutinib vs 0·14 [0·11-0·18] with teriflunomide (adjusted RR 1·02 [0·75-1·39]; p=0·55) in evolutionRMS1 and 0·11 (0·09-0·13 vs 0·11 [0·09-0·13]; adjusted RR 1·00 [0·74-1·35]; p=0·51) in evolutionRMS2. The pooled proportion of participants with any treatment-emergent adverse event (TEAE) was similar between treatment groups (976 [85·6%] of 1140 with evobrutinib vs 999 [87·2%] of 1146 with teriflunomide). The most frequently reported TEAEs were COVID-19 (223 [19·6%] with evobrutinib vs 223 [19·5%] with teriflunomide), alanine aminotransferase increased (173 [15·2%] vs 204 [17·8%]), aspartate aminotransferase increased (110 [9·6%] vs 131 [11·4%]), and headache (175 [15·4%] vs 176 [15·4%]). Serious TEAE incidence rates were higher with evobrutinib than teriflunomide (86 [7·5%] vs 64 [5·6%]). Liver enzyme elevations at least 5 × upper limit of normal were more common with evobrutinib than with teriflunomide, particularly in the first 12 weeks (55 [5·0%] vs nine [<1%]). Three people who received evobrutinib and one who received teriflunomide met the biochemical definition of Hy's law; all cases resolved after discontinuation of treatment. There were two deaths (one in each group), neither related to study treatment.INTERPRETATIONThe efficacy of evobrutinib was not superior to that of teriflunomide. Together, efficacy and liver-related safety findings do not support the use of evobrutinib in people with relapsing multiple sclerosis.FUNDINGMerck.

01 Nov 2024·The Lancet Neurology

Evobrutinib in multiple sclerosis: challenges and unmet goals

Article

Author: van der Walt, Anneke

News (Medical) associated with Evobrutinib

06 Sep 2024

·www.biospace.com

Roche and Sanofi MS Trials Show Potential, Challenges of Oral BTK Inhibitors

iStock, WhataWin Roche’s fenebrutinib this week scored a mid-stage win in relapsing multiple sclerosis, while Sanofi’s tolebrutinib met the primary endpoint in a Phase III trial for progressive MS but flopped in two late-stage relapsing MS studies. It was a big news week for multiple sclerosis clinical trial readouts involving oral BTK inhibitors, which leverage their small molecular structure to cross the blood-brain barrier. Roche was the outright winner while Sanofi announced mixed results. Sanofi’s tolebrutinib on Monday missed the primary efficacy endpoints in two Phase III studies, failing to significantly reduce annualized relapse rate (ARR) in patients with relapsing MS (RMS), while succeeding in a third late-stage trial showing that the BTK inhibitor significantly delayed disability progression in patients with a less common form of progressive MS. Still, according to GlobalData, tolebrutinib “stands out as being particularly promising” and is expected to generate sales of approximately $2.6 billion in 2030 across seven major markets—the U.S., France, Germany, Italy, Spain, U.K. and Japan. The data analytics firm predicted worldwide sales of fenebrutinib will only reach $810 million that same year. Jefferies analysts described positivity around tolebrutinib, saying in a note to investors that despite the “mixed news,” Sanofi’s drug “now appears a largely de-risked perhaps $1–2 billion opportunity.” Meanwhile, just two days after Sanofi’s announcement, Roche’s fenebrutinib scored a mid-stage win in RMS, demonstrating near-total elimination of disease activity. GlobalData said the BTK inhibitor “shines” with 96% of patients treated free of relapses at one year, with data from three ongoing Phase III trials expected by the end of next year. According to Spherix Global Insights, orally administered BTK inhibitors are “already established in oncology” with U.S. neurologists “eagerly” awaiting the drug class for MS. However, the market research firm contends that setbacks involving safety have created an environment of uncertainty. Liver Safety and Secondary Endpoints in Focus While the overall sentiment for BTK inhibitors for MS is positive, the safety pro these treatments remains a point of concern. Sanofi’s Phase III tolebrutinib studies were placed on partial clinical hold by the FDA in June 2022 after researchers found cases of drug-induced liver injury in some patients, while the regulator put Roche’s fenebrutinib under a partial clinical hold in December 2023 after two patients experienced elevated hepatic transaminase and bilirubin levels indicative of liver injury. According to Jefferies analysts, liver safety “will be a key focus” at the Sept. 20 presentations of Sanofi’s HERCULES and GEMINI 1 and 2 full results at the 40th Congress of European Committee for Treatment and Research in Multiple Sclerosis in Copenhagen, Denmark. Shiv Saidha, professor of neurology at Johns Hopkins University, said on a Jefferies call Thursday that another important aspect of these data will be the benefit across secondary endpoints, noting the failure last year of Merck KGaA’s BTK inhibitor evobrutinib to show benefit on these measures in MS before the German pharma decided in March 2024 to terminate its development. Although Sanofi’s Phase III GEMINI 1 and 2 trials did not demonstrate a reduction in ARR, GlobalData observed that pooled data from secondary endpoints suggested a significant delay in the onset of confirmed disability worsening, aligning with the positive confirmed disability progression findings from the late-stage HERCULES study, and “providing a measure of support for tolebrutinib’s potential efficacy.” Nevertheless, there appears to be a bit of a confidence problem in the wider drug class, Jefferies analysts noted. “Investor expectations have likely been notably lower after competitor Merck KGaA’s evobrutinib RMS failure.” So the question remains: Can orally administered BTK inhibitors ultimately succeed in MS like they have in oncology?

Phase 3Clinical Result

05 Sep 2024

·www.echemi.com

Roche Reveals Striking Data: 96% of Patients Did Not Relapse Within a Year, but Safety is in Doubt

Roche announced on September 4 the latest results from the Phase II FENopta Open Label Extension (OLE) study of the BTK inhibitor fenebrutinib. The results of the study showed that patients with relapsing multiple sclerosis (RMS) who received fenebrutinib for up to one year maintained extremely low levels of disease activity and did not experience disability progression. Roche plans to present the latest data from the FENopta-OLE study at the 40th session of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). Fenebrutinib is an oral, reversible, non-covalently bound BTK inhibitor that can effectively block the function of BTK. Preclinical studies have shown that fenebrutinib has significant activity and is highly selective, being 130 times more selective to BTK than other kinases. Currently, fenebrutinib is the only reversible BTK inhibitor in Phase III trials for the treatment of multiple sclerosis. The FENopta study is a 12-week global, randomized, double-blind, placebo-controlled Phase II clinical trial designed to evaluate the efficacy, safety, and pharmacokinetics of fenebrutinib in 109 RMS patients aged 18 to 55 years. The primary endpoint was the number of new T1 lesions (T1-GD +) detected by brain magnetic resonance imaging (MRI) at weeks 4, 8, and 12, while secondary endpoints included the number of new/expanded T2 lesions detected by brain MRI at weeks 4, 8, and 12. And the proportion of patients with new T1-Gd+ lesions and new/enlarged T2 lesions at week 4, 8 and 12. T1 lesions are markers of active inflammation, while T2 lesions represent disease burden or lesion load. Data from the 12-week study showed that fenebrutinib significantly reduced the number of new T1 lesions and new/enlarged T2 lesions compared to the placebo group. Of the patients who completed the FENopta study, 99 chose to continue participating in the Open Label Extension (OLE) study to receive fenebrutinib for up to 192 weeks. During OLE, 96% of patients treated with fenebrutinib were disease free at one year, with an annualized recurrence rate (ARR) of 0.04, and disability remained stable at 48 weeks. MRI scans showed that fenebrutinib treatment effectively suppressed disease activity in the brain. At 48 weeks, 99% of patients had no T1-Gd+ lesions. Within 48 weeks of continued treatment with fenebrutinib, T2 lesion volume decreased by a factor of 3 compared to the end of the double-blind period (-0.33 cm3 vs -0.11 cm3). The safety profile of Fenebrutinib in OLE is consistent with previously reported data. The most common adverse events (aes) in more than 5% of patients included urinary tract infections (8%), COVID-19 (7%), and pharyngitis (5%). One patient (1%) had a serious adverse event. Another patient (1%) had an asymptomatic elevation of alanine aminotransferase (ALT), which returned to normal after discontinuation. There are currently three ongoing Phase III clinical trials of fenebrutinib, including the FENhance 1 and FENhance 2 studies in patients with RMS, and the FENtrepid study in patients with primary progressive multiple sclerosis (PPMS). Data from these studies are expected to be available by the end of 2025. Levi Garraway, MD, Roche's chief medical officer and head of global product development, said: "After one year of treatment, our BTK inhibitor fenebrutinib was able to effectively inhibit virtually all disease activity and disability progression in patients with multiple sclerosis. If these results are confirmed in the ongoing Phase III study, fenebrutinib is expected to further improve the treatment landscape for patients with multiple sclerosis." According to the information of the Medical Rubik's Cube database, a total of 4 BTK inhibitors are currently undergoing phase III clinical studies for multiple sclerosis in the world, and fenebrutinib is the only third-generation BTK inhibitor. The other three are evobrutinib (Merck), remibrutinib (Novartis) and tolebrutinib (Sanofi). In addition, there are three BTK inhibitors in Phase II clinical studies in multiple sclerosis, including obutinib (Norzenogenat), pitobutinib (Eli Lilly), and BIIB091 (Bogen).

Phase 2Clinical ResultPhase 3

03 Sep 2024

·www.biospace.com

Sanofi’s Tolebrutinib Misses Two of Three Late-Stage Multiple Sclerosis Readouts

iStock, JHVEPhoto The BTK inhibitor showed promise in non-relapsing secondary progressive multiple sclerosis but not relapsing MS. The company said it plans to apply for approval for the former “as soon as possible.” Sanofi ’s investigational BTK inhibitor tolebrutinib missed the primary efficacy endpoints in the Phase III GEMINI 1 and GEMINI 2 studies, failing to significantly improve relapse rates in patients with relapsing multiple sclerosis, according to a company announcement of three late-stage readouts on Monday. A third trial, however, succeeded. Results from the Phase III HERCULES study showed that tolebrutinib significantly delayed disability progression in patients with non-relapsing secondary progressive multiple sclerosis (nrSPMS). Early analysis of toxicities also showed that tolebrutinib’s liver safety pro consistent with what had been established in prior studies, according to Sanofi. The pharma did not provide specific data from any of the studies in its news release, instead promising to reveal more detailed findings and analyses from the trials at the upcoming European Committee for Treatment and Research in Multiple Sclerosis, happening later this month in Copenhagen. “Tolebrutinib represents an unprecedented breakthrough as a potential first-in-disease treatment option with clinically meaningful benefit in disability accumulation,” Houman Ashrafian, Sanofi’s head of R&D, said in a statement. The accumulation of disabilities in patients as their disease progresses “remains the greatest unmet medical need” in nrSPMS patients. In an interview with Fierce Biotech , Ashrafian added that Monday’s triple readouts “bring into sharp focus which patient population we should be treating.” The pharma plans to tolebrutinib’s approval in nrSPMS “as soon as possible,” he said. MS is a chronic, neurodegenerative disorder that arises when the body’s immune system attacks the protective covering of its own nerve cells. It typically manifests as numbness or weakness in the limbs, lack of coordination and unsteady gait and partial or complete blindness. According to Sanofi’s news release, the accumulation of disabilities is a central and largely under-addressed problem in MS. For instance, in relapsing MS, patients experience episodes of worsening symptoms, also called relapses, alternating with periods of recovery. While nrSPMS does not include relapses, patients continue to accumulate disabilities such as fatigue, impaired cognition and sexual dysfunction. Tolebrutinib is an orally available and brain-penetrant inhibitor of the BTK protein, which is a central player in the development of the antibody-producing B cells. Through this mechanism of action, tolebrutinib can help temper the activity of B lymphocytes and disease-driving microglia. In addition to tolebrutinib, Sanofi is also addressing MS with its anti-CD40L antibody frexalimab. In February 2024, the company reported Phase II data for frexalimab, demonstrating a significant reduction in disease activity and active inflammation in patients with relapsing MS. Tolebrutinib’s road to Monday’s readouts has been rough. In June 2022, the FDA put a partial clinical hold on Phase III trials of the drug, suspending enrollment into these studies. The regulatory pause was triggered by multiple cases of drug-induced liver injuries. Aside from the HERCULES and the GEMINI studies, Sanofi continues to evaluate tolebrutinib in the Phase III PERSEUS trial, for primary progressive MS. PERSEUS is expected to read out next year. Monday’s back-to-back Phase III failures for tolebrutinib illustrate the difficulty of advancing BTK inhibitors in MS. In December 2023, for instance, Merck KGaA’s evobrutinib also failed its Phase III evolutinRMS 1 and evolutionRMS 2 studies, unable to significantly curb relapse rates in patients. A few months later, in March 2024, the German pharma announced it had discontinued the development of evobrutinib in MS. Fellow pharma powerhouse Roche has also struggled with MS, announcing in December 2023 that its investigational BTK inhibitor fenebrutinib was put under partial clinical hold after the FDA detected multiple cases of liver injury.

Phase 2Phase 3Clinical Result

100 Deals associated with Evobrutinib

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Rhabdomyosarcoma	Discovery	US	Merck KGaA	10 Sep 2019
Rhabdomyosarcoma	Discovery	DE	Merck KGaA	10 Sep 2019
Multiple sclerosis relapse	Discovery	US	Merck KGaA	26 Aug 2019
Multiple sclerosis relapse	Discovery	DE	Merck KGaA	26 Aug 2019
Multiple Sclerosis, Relapsing-Remitting	Discovery	DE	Merck KGaA	26 Aug 2019
Multiple Sclerosis, Relapsing-Remitting	Discovery	US	Merck KGaA	26 Aug 2019
Systemic Lupus Erythematosus	Discovery	DE	Merck KGaA	04 Jan 2017
Systemic Lupus Erythematosus	Discovery	JP	Merck KGaA	04 Jan 2017
Rheumatoid Arthritis	Discovery	DE	Merck KGaA	31 Jul 2016
Rheumatoid Arthritis	Discovery	US	Merck KGaA	31 Jul 2016

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04338061 \| NCT04338022 (evolutionRMS 1, Biospace) Manual	Phase 3	Multiple sclerosis relapse	-	Evobrutinib (evolutionRMS 1)	(ftlazfsvta) = avosojvwrf iohmymnkus (akkfvlovsm ) Not Met	Negative	05 Dec 2023
				teriflunomide (evolutionRMS 1)	(ftlazfsvta) = rbbvjiswua iohmymnkus (akkfvlovsm ) Not Met
NCT02975349 (Phase 2 OLE, ECTRIMS2023)	Phase 2	Bruton Type Agammaglobulinemia	267	Evobrutinib 25mg QD	(pcmyleisow) = Treatment-emergent adverse events (TEAEs) were reported by 142/164 PwRMS (86.6%) wreissizzg (nezukgybbf ) View more	Positive	30 Sep 2023
				Evobrutinib 75mg BID
ACTRIMS2023	Not Applicable	Neuroinflammation	-	Evobrutinib	zvdwzaolow(tksbigdfnl) = mehpykphgk zkidjimblc (nssgcsscgw )	Positive	30 May 2023
				Anti-CD20 (clone: SA271G2)	(nekuejbkgg) = jcnvfpxbju btpreovmay (lrvrydptgj ) View more
ACTRIMS2023	Not Applicable	Multiple sclerosis relapse	-	Evobrutinib 75 mg twice-daily	ednsulyiyg(ndbjqyddkd) = npzmhktpes yxcbwzwbpu (pludljnnzg, 4.5)	-	30 May 2023
				mRNA COVID-19 vaccine	ednsulyiyg(ndbjqyddkd) = qviuokqjbs yxcbwzwbpu (pludljnnzg, 4.3)
AAN2023	Not Applicable	Neuroinflammation	-	Evobrutinib	kkjihyhtjx(zjsxcjxjub) = rnlrqoshvc vcuicdfcqx (aianyuyemf ) View more	Positive	25 Apr 2023
AAN2023	Phase 3	Multiple Sclerosis BTK	-	Tolebrutinib	njeoxpohux(jakxjmrckx) = tsbegzuhrk msvqosayra (oepnjczfct, 0.40) View more	Positive	25 Apr 2023
				Evobrutinib	njeoxpohux(jakxjmrckx) = dpvibbybyu msvqosayra (oepnjczfct, 0.13) View more
NCT03233230 \| NCT02975349 \| NCT02975336 (Pubmed)	Phase 2	Multiple Sclerosis \| Rheumatoid Arthritis \| Systemic Lupus Erythematosus	1,083	Evobrutinib	(tdrodaonti) = rhghuvrulf pkjslykqcr (lbhxazcwgs ) View more	-	23 Nov 2022
				Placebo	(tdrodaonti) = vpxlkjbgbm pkjslykqcr (lbhxazcwgs ) View more
NCT02975349 (ECTRIMS2022)	Phase 2	Multiple sclerosis relapse	267	Evobrutinib 75mg QD	pqhfspkxko(sfrfjjjvhs) = byrqydfdqt tkvvvcahkl (oodnybrvbp )	-	12 Oct 2022
				Evobrutinib 75mg BID	pqhfspkxko(sfrfjjjvhs) = sjkqvjngdk tkvvvcahkl (oodnybrvbp )
NCT02975349 (Phase II trial, EAN)	Phase 2	-	-	Evobrutinib 25mg QD	isoitgyicr(atorievypl) = wiiimwbtdr hfspajctqb (swmolhzext, -618.0 to 309.0)	Positive	24 Jun 2022
				Evobrutinib 75mg QD	isoitgyicr(atorievypl) = bxacdtdlip hfspajctqb (swmolhzext, -712.0 to 97.0)
NCT02975336 (Phase II trial, EAN)	Phase 2	Influenza, Human	-	Evobrutinib 75mg QD	(gbjuraijqg) = tydlgvbmja haqvsrsrgi (ffqjfygrvp ) View more	Positive	24 Jun 2022
				Placebo	(gbjuraijqg) = zkkotktzft haqvsrsrgi (ffqjfygrvp ) View more

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