Delving into the Latest Updates on Opicinumab with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Anti-LINGO-1 antibody, Opicinumab (USAN/INN), ANTI-LINGO 1

+ [2]

Target

LINGO-1

Mechanism

LINGO-1 inhibitors(Leucine-rich repeat and immunoglobulin-like domain-containing nogo receptor-interacting protein 1 inhibitors), Cell differentiation stimulants

Therapeutic Areas

Immune System DiseasesNervous System DiseasesEye Diseases+ [1]

Active Indication-

Inactive Indication

Multiple sclerosis relapseMultiple Sclerosis, Relapsing-RemittingOptic Neuritis

Originator Organization

Biogen, Inc.

Dyax Corp.

Active Organization-

Inactive Organization

Biogen, Inc.

Drug Highest PhaseDiscontinuedPhase 2

First Approval Date-

Regulation-

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Gene Sequence

Sequence Code 1311317H

Source: *****

Sequence Code 9535515L

Source: *****

The primary objective of Part 1 of this study is to evaluate the effects of BIIB033 versus placebo on disability improvement over 72 weeks. The primary objective of Part 2 of this study is to evaluate the long-term safety profile of BIIB033 as an add-on therapy in participants with MS.
The secondary objective of Part 1 is to evaluate the effects of BIIB033 versus placebo on additional measures of disability improvement. The secondary objective of Part 2 is to investigate long-term efficacy (disability improvement) and additional safety measures of BIIB033 as an add-on therapy in participants with MS.

Start Date15 Nov 2017

Sponsor / Collaborator

Biogen, Inc.

NCT02833142 / CompletedPhase 1

A Randomized, Blinded, Parallel-Group, Phase 1 Study of Pharmacokinetics, Safety and Tolerability of Single Intravenous Doses of BIIB033 (Opicinumab ) Produced by 2 Manufacturing Processes, in Healthy Volunteers

The primary objective of the study is to characterize the pharmacokinetics (PK) of BIIB033-B and to compare the PK profile with that of BIIB033-A in healthy volunteers. Secondary objectives are: To assess the safety and tolerability of BIIB033-A and BIIB033-B; To assess the secondary PK parameters of BIIB033-A and BIIB033-B; To assess the immunogenicity of BIIB033-A and BIIB033-B.

Start Date01 Jul 2016

Sponsor / Collaborator

Biogen, Inc.

NCT02657915 / CompletedPhase 2

A Multicenter, Follow-Up Study to Assess Long-Term Electrophysiologic and Clinical Outcomes in Subjects Previously Enrolled in Study 215ON201

The primary objective of the study is to assess full-field visual evoked potential (FF-VEP) latency in subjects who were enrolled in Study NCT01721161 2 years (+ up to 12 months) after the last study visit. The secondary objective is to assess clinical progression and severity of central nervous system (CNS) demyelinating disease in subjects who were enrolled in Study NCT01721161 2 years (+ up to 12 months) after the last study visit. Intervention was administered in the previous study. The participants, investigator and outcome assessors remain blinded in this follow-up study.

Start Date10 Mar 2016

Sponsor / Collaborator

Biogen, Inc.

100 Clinical Results associated with Opicinumab

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100 Translational Medicine associated with Opicinumab

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100 Patents (Medical) associated with Opicinumab

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54

Literatures (Medical) associated with Opicinumab

01 Jan 2024·Neuroscience letters

Antagonizing LINGO-1 reduces activated microglia and alleviates dendritic spine loss in the hippocampus of APP/PS1 transgenic mice

Article

Author: Wang, Jin ; Yang, Hao ; Xie, Yu-Han ; Zhu, Lin ; Luo, Yan-Min ; Chao, Feng-Lei ; Zhou, Yu-Ning ; Deng, Yu-Hui ; Jiang, Lin ; Zhou, Chun-Ni ; He, Qi ; Huang, Du-Juan ; Liang, Xin ; Zhang, Yi ; Tang, Yong

In Alzheimer's disease (AD), microglia are involved in synaptic pruning and mediate synapse loss. LINGO-1 is a negative regulator of nerve growth, and whether antagonizing LINGO-1 can attenuate synaptic pruning by microglia and rescue dendritic spines in the hippocampus in AD is still unclear. On this basis, the anti-LINGO-1 antibody, which binds to LINGO-1 protein and antagonizes the effects of LINGO-1, was administered to 10-month-old APP/PS1 transgenic mice for 2 months. The Morris water maze test, immunohistochemical and stereological methods, immunofluorescence and 3D reconstruction were used. Compared to wild-type mice, APP/PS1 transgenic mice had worse performance on behavioral tests, fewer dendritic spines but more microglia in the hippocampus. Meanwhile, the microglia in APP/PS1 transgenic mice had more branches of medium length (4-6 µm) and a cell body area with greater variability. Moreover, APP/PS1 transgenic mice had more postsynaptic termini colocalized with microglia in the hippocampus than wild-type mice. The anti-LINGO-1 antibody significantly reversed these changes in AD, indicating that the anti-LINGO-1 antibody can improve hippocampus-dependent learning and memory abilities and effectively rescue dendritic spines in the hippocampus of AD mice and that microglia might participate in this progression in AD. These results provide a scientific basis for further studying the mechanism of the anti-LINGO-1 antibody in AD and help to elucidate the role of LINGO-1 in the treatment of AD.

01 Aug 2023·Neuroscience research

Anti-LINGO-1 antibody protects neurons and synapses in the medial prefrontal cortex of APP/PS1 transgenic mice

Article

Author: Zhou, Yu-Ning ; Xiao, Qian ; Yang, Hao ; He, Qi ; Jiang, Lin ; Tang, Yong ; Chao, Feng-Lei ; Wang, Yi-Ying ; Zhou, Chun-Ni ; Huang, Du-Juan ; Zhang, Yi ; Luo, Yan-Min

The medial prefrontal cortex (mPFC), one of the most vulnerable brain regions in Alzheimer's disease (AD), plays a critical role in cognition. Leucine-rich repeat and immunoglobulin-like domain-containing nogo receptor-interacting protein-1 (LINGO-1) negatively affects nerve growth in the central nervous system; however, its role in the pathological damage to the mPFC remains to be studied in AD. In this study, an anti-LINGO-1 antibody was administered to 10-month-old APP/PS1 mice, and behavioral tests, stereological methods, immunohistochemistry and immunofluorescence were used to answer this question. Our results revealed that LINGO-1 was highly expressed in the neurons of the mPFC of AD mice, and the anti-LINGO-1 antibody improved prefrontal cortex-related function and reduced the protein level of LINGO-1, atrophy of the volume, Aβ deposition and massive losses of synapses and neurons in the mPFC of AD mice. Antagonizing LINGO-1 could effectively alleviate the pathological damage in the mPFC of AD mice, which might be an important structural basis for improving prefrontal cortex-related function. Abnormal expression of LINGO-1 in the mPFC may be one of the key targets of AD, and the effect initiated by the anti-LINGO-1 antibody may provide an important basis in the search for drugs for the prevention and treatment of AD.

01 May 2023·Multiple sclerosis (Houndmills, Basingstoke, England)

Lesion-level correspondence and longitudinal properties of paramagnetic rim and slowly expanding lesions in multiple sclerosis

Article

Author: Fetco, Dumitru ; Fisher, Elizabeth ; Belachew, Shibeshih ; Elliott, Colm ; Bradley, Daniel P ; Tian, Zhe ; Zhu, Bing ; Araujo, David ; Gafson, Arie ; Arnold, Douglas L ; Rudko, David A ; Elkady, Ahmed M

Background::

Paramagnetic rim lesions (PRLs) and slowly expanding lesions (SELs) have been posited as markers of chronic active lesions (CALs).

Objective::

To assess the lesion-level concordance of PRLs and SELs in MS and to characterize changes in brain tissue integrity in CALs over time.

Methods::

MRIs were analyzed from a substudy of AFFINITY [NCT03222973], a phase 2 trial of opicinumab in relapsing MS. Assessments included (1) identification of SELs based on longitudinal MRIs over 72 weeks, and identification of PRLs on susceptibility-weighted imaging (SWI) filtered phase images at week 72; (2) evaluation of subject-level correlation of SEL and PRL counts, volumes, and degree of lesion-level overlap between SELs and PRLs; and (3) characterization of tissue integrity over time in overlapping and non-overlapping SELs and PRLs.

Results::

In 41 subjects, 119 chronic PRLs and 267 SELs were detected. Of 119 (39.5%) chronic PRLs, 47 co-localized with a SEL; 46/267 (17.2%) SELs co-localized with a PRL. PRLs co-localized with SELs showed expansion and worsening microstructural damage over time. SELs with and without co-localization with PRLs showed ongoing tissue damage.

Conclusions::

Chronic MS lesions identified as both PRL and SEL were associated with the most severe accumulation of tissue damage.

Trial Registration::

AFFINITY [NCT03222973].

100 Deals associated with Opicinumab

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External Link

KEGG	Wiki	ATC	Drug Bank
D11767	Opicinumab	-	DB14959

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Multiple sclerosis relapse	Phase 2	US	Biogen, Inc.	01 Aug 2013
Multiple sclerosis relapse	Phase 2	CA	Biogen, Inc.	01 Aug 2013
Multiple sclerosis relapse	Phase 2	CZ	Biogen, Inc.	01 Aug 2013
Multiple sclerosis relapse	Phase 2	FR	Biogen, Inc.	01 Aug 2013
Multiple sclerosis relapse	Phase 2	HU	Biogen, Inc.	01 Aug 2013
Multiple sclerosis relapse	Phase 2	IT	Biogen, Inc.	01 Aug 2013
Multiple sclerosis relapse	Phase 2	NL	Biogen, Inc.	01 Aug 2013
Multiple sclerosis relapse	Phase 2	PL	Biogen, Inc.	01 Aug 2013
Multiple sclerosis relapse	Phase 2	RU	Biogen, Inc.	01 Aug 2013
Multiple sclerosis relapse	Phase 2	RS	Biogen, Inc.	01 Aug 2013

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03222973 (AFFINITY, CTgov)	Phase 2	Multiple sclerosis relapse	263	placebo (Part 1: Placebo)	fxdmmtzjli(plgdefyplf) = tvvapjmwfz ognpzxkinn (wyswyxenbd, liqcltmtif - epzjxdotwk) View more	-	28 Apr 2022
				BIIB033 (Part 1: BIIB033 750 mg)	fxdmmtzjli(plgdefyplf) = miuppkzvkz ognpzxkinn (wyswyxenbd, jkxiyvuuat - yyvthbgyil) View more
NCT01721161 (RENEW, ECTRIMS2020)	Phase 2	-	82	Opicinumab 100 mg/kg	uqsztubxhj(qpzreuyqqm) = auhpodguxy mhxctzwkte (eekvmiuffl )	Positive	07 Dec 2020
				Placebo	uqsztubxhj(qpzreuyqqm) = cjfupgueck mhxctzwkte (eekvmiuffl )
NCT01721161 (RENEW, AAN2020)	Phase 2	Optic Neuritis	82	Opicinumab	fdvudntrfs(hcinfgubow) = kohuczmbvx yvhvxelpgh (iruiylaokb )	-	14 Apr 2020
				Placebo	fdvudntrfs(hcinfgubow) = irhitmfyar yvhvxelpgh (iruiylaokb )
NCT02657915 (RENEWED, CTgov)	Phase 2	Optic Neuritis	52	Placebo	qagilwfddz(cikkszlvor) = bcssqhlijy hqdefjbmdy (tdrbrhzxxj, oducyxdron - vaejncmldj) View more	-	23 Sep 2019
NCT01864148 (SYNERGY, AAN2018)	Phase 2	Multiple sclerosis relapse	-	Opicinumab 10 mg/kg	(qdmagqlpgy) = fcjycchlwp gyqxexwyoi (nvunqatskc )	-	10 Apr 2018
				Placebo (IM IFN beta-1a only)	(qdmagqlpgy) = edyjxjbpep gyqxexwyoi (nvunqatskc )
NCT01864148 (SYNERGY, CTgov)	Phase 2	Multiple sclerosis relapse	419	Placebo+AVONEX (Placebo)	urjpfdrexx(ycufeishju) = xrxevjskmy upkdibthgu (ofqdtyteck, aaywacfjml - zsppwgihby) View more	-	03 May 2017
				BIIB033+AVONEX (BIIB033, 3 mg/kg)	urjpfdrexx(ycufeishju) = jujxamawgv upkdibthgu (ofqdtyteck, fsnhwyslya - vfupplwksl) View more
NCT01721161 (RENEW, CTgov)	Phase 2	Optic Neuritis	82	Placebo (Placebo)	wxdfziurup(idawpgxqen) = xcsuhrzoak sivqtvazss (jjnbmgudov, zttyszatfq - abdrnpqtyv) View more	-	30 Jun 2016
				BIIB033 (anti-LINGO-1 mAb) (BIIB033)	wxdfziurup(idawpgxqen) = ofhuetbbqo sivqtvazss (jjnbmgudov, mctnfzrkio - ytssyruciw) View more
NCT01721161 (RENEW, AAN2016)	Phase 2	Optic Neuritis	82	Anti-LINGO-1 IV	reqoxcnbmo(iyuxswvkop) = bnkqahpbpb vnhmepkqqg (ccsibmgygp )	-	05 Apr 2016
				Placebo	reqoxcnbmo(iyuxswvkop) = ahqvkfookt vnhmepkqqg (ccsibmgygp )
NCT01721161 (RENEW, AAN2016)	Phase 2	Optic Neuritis	82	Anti-LINGO-1 IV 100 mg/kg	bulytrxktx(rwthsoyobl) = oyanmsbrho kwhfugorky (dkucpomupu )	Positive	05 Apr 2016
				Placebo	bulytrxktx(rwthsoyobl) = duwidinxcv kwhfugorky (dkucpomupu )