Delving into the Latest Updates on Quetmolimab with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Quetmolimab (USAN)

+ [2]

Target

CX3CL1

Mechanism

CX3CL1 antagonists(C-X3-C motif chemokine ligand 1 antagonists)

Therapeutic Areas

Digestive System Disorders

Active Indication

Crohn Disease

Inactive Indication

Primary Biliary CholangitisRheumatoid Arthritis

Originator Organization

Eisai Co., Ltd.

Active Organization

EA Pharma Co., Ltd.

Inactive Organization

Eisai Co., Ltd.

Eisai, Inc.

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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Gene Sequence

Sequence Code 263360826L

Source: *****

Sequence Code 263360825H

Source: *****

ABSTRACTObjectivesTo evaluate the long-term safety and efficacy of E6011, a humanized anti-fractalkine monoclonal antibody, in patients with rheumatoid arthritis (RA) with an inadequate response to methotrexate (MTX).MethodsActive RA patients with an inadequate response to MTX were randomly assigned to the E6011 or placebo group and received the study drug subcutaneously every 2 weeks during a 24-week double-blind study period. Subjects who completed evaluations at Week 24 were rolled over into the extension phase and received open-label E6011 (200 or 400 mg) every 2 weeks until Week 102. The safety analysis was conducted up to Week 104, and the efficacy analysis was conducted up to Week 84.ResultsA total of 169 subjects completed the double-blind treatment phase and were rolled over into the extension phase. In total, 167 (98.8%) subjects experienced any adverse events, and the incidence of treatment-related adverse events was 56.2%. The American College of Rheumatology 20 response rates were observed between 40 and 70% during the extension phase.ConclusionsE6011 was safe and well tolerated with no notable safety concerns up to 102 weeks in RA patients with an inadequate response to MTX.

22 Dec 2023·Modern Rheumatology

Long-term evaluation of E6011, an anti-fractalkine monoclonal antibody, in patients with rheumatoid arthritis inadequately responding to biological disease-modifying antirheumatic drugs

Article

Author: Umehara, Hisanori ; Yasuda, Nobuyuki ; Kitahara, Yasumi ; Torii, Kentaro ; Tanaka, Yoshiya ; Kawakubo, Makoto ; Hojo, Seiichiro ; Nanki, Toshihiro ; Kawano, Tetsu ; Yamanaka, Hisashi ; Takeuchi, Tsutomu ; Imai, Toshio ; Tago, Fumitoshi

ABSTRACTObjectivesThe objective of the study is to evaluate the long-term safety and efficacy of E6011, a humanized anti-fractalkine monoclonal antibody, in patients with rheumatoid arthritis with an inadequate response to biological disease-modifying antirheumatic drugs.MethodsIn the double-blind treatment phase (24 weeks), placebo or E6011 400 mg was administered until Week 10. Thereafter, E6011 200 mg or 400 mg was administered to Week 22. Subjects who completed the evaluation at Week 24 of the treatment phase were rolled over into the extension phase. The extension phase lasted until Week 104, and all subjects received E6011 400 mg or 200 mg every 2 weeks in an open-label manner until Week 102.ResultsA total of 47 subjects completed the double-blind treatment phase and were rolled over into the extension phase. In total, 46 (97.9%) subjects experienced any adverse events, and the incidence of treatment-related adverse events was 57.4%. No clear efficacy trend in the American College of Rheumatology 20% response rates was observed.ConclusionsE6011 was well tolerated in active rheumatoid arthritis patients who had shown an inadequate response to biologic disease-modifying antirheumatic drugs, but no clear benefit in the American College of Rheumatology 20% response rates was observed. Further studies are needed to clarify the clinical benefit of E6011.

01 Nov 2023·Journal of Pharmacological and Toxicological Methods

Quantification of anti-drug antibodies against E6011, an anti-fractalkine monoclonal antibody, in monkey and human serum, by an electrochemiluminescence assay

Article

Author: Mano, Yuji ; Aoyama, Muneo

E6011, a humanized anti-fractalkine monoclonal antibody, is under development for the treatment of various inflammatory diseases, such as rheumatoid arthritis. Therapeutic antibodies may induce production of anti-drug antibodies (ADA) that may deteriorate efficacy and/or enhance immunogenic reaction. It is important to have an ADA assay to understand the characteristics of biotherapeutics under development. A simple and reproducible assay has thus been developed for the determination of ADA against E6011 in monkey and human serum by electrochemiluminescence (ECL) detection. An immune-complex of biotinylated E6011, ADA, and ruthenium-labeled E6011 was attached to avidin-coated wells for ECL signal detection. Screening and confirmatory cutpoints were determined to judge negative or positive ADA. Sensitivity of ADA was 1.61 and 1.34 ng/mL in monkey and human serum, respectively. Accuracy and precision of the assay were within ±20% and 20%, respectively. Drug tolerance of the assay in monkey and human sera was ensured up to 100 and 1000 μg/mL E6011 at the surrogate ADA levels of 1 and 4 μg/mL, respectively. The developed assay was successfully applied to ADA quantification in monkeys and humans in support of immunogenicity assessments.

100 Deals associated with Quetmolimab

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External Link

KEGG	Wiki	ATC	Drug Bank
D11498	-	-	-

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Crohn Disease	Phase 2	RU	EA Pharma Co., Ltd.	25 Apr 2019
Crohn Disease	Phase 2	CZ	EA Pharma Co., Ltd.	25 Apr 2019
Crohn Disease	Phase 2	PL	EA Pharma Co., Ltd.	25 Apr 2019
Crohn Disease	Phase 2	HU	EA Pharma Co., Ltd.	25 Apr 2019
Crohn Disease	Phase 2	JP	EA Pharma Co., Ltd.	25 Apr 2019
Primary Biliary Cholangitis	Discovery	JP	EA Pharma Co., Ltd.	29 May 2017
Rheumatoid Arthritis	Discovery	JP	Eisai Co., Ltd.	20 Oct 2016

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02039063 (CTgov)	Phase 1/2	Crohn Disease	28	E6011 (Cohort 1: E6011 2 mg/kg)	zvpxfwfjkb(exjhqfpwuh) = pnhgiogkem gtvegbmbqh (saopypndbl, lgvienzytm - xnjpdmobso) View more	-	30 Jan 2023
				E6011 (Cohort 2: E6011 5 mg/kg)	zvpxfwfjkb(exjhqfpwuh) = ewqzyfzpvf gtvegbmbqh (saopypndbl, mxtzycscgb - orafydgopt) View more
NCT02960490 (CTgov)	Phase 2	Rheumatoid Arthritis	66	placebo+E6011 (Core Treatment Phase: Placebo)	mbuohxrmvg(butqzvexay) = gkgfkyflgi tdwyveohxr (dtbmlduili, fzmuxpajjf - benxuuumwt) View more	-	23 Aug 2021
				E6011 (Core Treatment Phase: E6011 400 mg)	mbuohxrmvg(butqzvexay) = qfukhssfgy tdwyveohxr (dtbmlduili, mfhhdxeece - fcdfvtxqyo) View more
NCT02039063 (Pubmed \| J Gastroenterol Hepatol) Manual	Phase 1	Crohn Disease	28	E6011	(eyjqkrvgtz) = nuirdajrcv gwelkbtkoa (qprtsrubhg ) View more	Positive	01 Aug 2021
NCT02960490 (Pubmed \| Isr Med Assoc J) Manual	Phase 2	Rheumatoid Arthritis	64	E6011	(ikvyfgfgwj) = oumpwrvdfm xopvnbcdco (rndgtlwbtd ) View more	Negative	01 Jul 2021
				Placebo	(ikvyfgfgwj) = tqduefjvve xopvnbcdco (rndgtlwbtd ) View more
NCT02196558 (E6011, CTgov)	Phase 1/2	Rheumatoid Arthritis	53	E6011 (E6011: 100 mg)	ftzuxwbjnw(qjrvcxoonz) = llezylhlhr pekavkqcqg (sucgjboxgg, uqqlygengq - cpfhmstkqs) View more	-	13 Aug 2020
				E6011 (E6011: 200 mg)	ftzuxwbjnw(qjrvcxoonz) = jilrkfehqp pekavkqcqg (sucgjboxgg, zpweqlenba - btxdyjrgjl) View more
NCT02960438 (phase 2, EULAR2020)	Phase 2	Rheumatoid Arthritis CX3CR1 + \| CD16 - \| CD56 + ... View more	190	E6011	(whigaerbzc) = vevtbazwch vuhgqrudfi (fveufofjrm )	Positive	03 Jun 2020
				Placebo	(whigaerbzc) = anafisxzow vuhgqrudfi (fveufofjrm )
NCT02960438 (EULAR2019)	Phase 2	Rheumatoid Arthritis CD16+ monocytes	190	E6011 100 mg	(ffhjjpppsz) = fhbbelyzba nbenlgxdwz (vontqyetra )	Positive	12 Jun 2019
				E6011 200 mg	(ffhjjpppsz) = kgbzgwigzb nbenlgxdwz (vontqyetra )
NCT02960490 (EULAR2019)	Phase 2	Rheumatoid Arthritis	64	E6011 400 mg	(ldimjcopeu) = tmdafipfmi rkaahbpftr (vchooiwfgn ) View more	Negative	12 Jun 2019
				Placebo	(ldimjcopeu) = copgrubuoz rkaahbpftr (vchooiwfgn ) View more
NCT02196558 (Pubmed \| Isr Med Assoc J)	Phase 1/2	Rheumatoid Arthritis	53	E6011 100 mg	(gwunjyidce) = qbgwujxqox dbjudpqptt (htzybvfbep ) View more	Positive	01 Jan 2018
				E6011 200 mg	(gwunjyidce) = nfutcifsoj dbjudpqptt (htzybvfbep ) View more