Delving into the Latest Updates on Opicinumab with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

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

+ [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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Structure/Sequence

Sequence Code 9535515L

Source: *****

Sequence Code 1311317H

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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56

Literatures (Medical) associated with Opicinumab

01 Jan 2025·Multiple Sclerosis and Related Disorders

RENEWED: A follow-up study of the opicinumab phase 2 RENEW study in participants with acute optic neuritis

Article

Author: Franchimont, Nathalie ; Balcer, Laura J ; Galetta, Steven L ; Bradley, Daniel P ; Leocani, Letizia ; Aktas, Orhan ; Cheng, Wenting ; Ziemssen, Focke ; Naylor, Maria L ; Butzkueven, Helmut ; Ziemssen, Tjalf ; Castrillo-Viguera, Carmen ; Izquierdo, Guillermo ; Belachew, Shibeshih ; Klistorner, Alexander ; Zhu, Bing

BACKGROUNDThe randomized, phase 2 RENEW trial (NCT01721161) evaluated efficacy/safety of opicinumab (anti-LINGO-1) versus placebo in patients with first-episode unilateral acute optic neuritis (AON). Although no significant differences in the latency recovery of visual evoked potential (VEP) were observed between opicinumab and placebo groups in the intention to treat (ITT) population, the prespecified per-protocol (PP) population showed better recovery with opicinumab than with placebo. RENEWED (NCT02657915) was a one-visit, follow-up study 2 years after the last RENEW study visit (Week 32) designed to assess the long-term electrophysiological and clinical outcomes for participants previously enrolled and having received study treatment in RENEW.METHODSIn the original study (RENEW), participants (aged 18-55 years) with a first unilateral AON episode were enrolled ≤28 days from first symptom onset and after treatment with methylprednisolone 1 g/day intravenously for 3-5 days; these participants were randomized to receive opicinumab 100 mg/kg or placebo intravenously once every 4 weeks from baseline to Week 20, assessed up to Week 32. Participants who received ≥1 dose of opicinumab 100 mg/kg or placebo in RENEW were eligible for the RENEWED follow-up study. Participants enrolled in RENEWED at 2 years (with an additional up to 12-month window) after the last RENEW study visit (Week 32) in both ITT and PP populations. The primary endpoint was change in full-field VEP (FF-VEP) latency of the affected eye at RENEWED study visit versus baseline of the fellow eye in RENEW, comparing between participants who received opicinumab and placebo in RENEW. Clinical progression and severity of multiple sclerosis (MS) were assessed. A substudy evaluated latency recovery using multifocal VEP (mfVEP) as an exploratory endpoint.RESULTSOf 82 RENEW participants, 52 (63.4 %; opicinumab n = 28, placebo n = 24) enrolled in and completed RENEWED. The adjusted mean (95 % CI) difference in FF-VEP latency delay between opicinumab and placebo groups was -6.0 (-14.6, 2.6) msec (p = 0.165) for the PP population and -4.5 (-12.6, 3.7) msec (p = 0.274) for the ITT population at the RENEWED study visit. Nominally significant improvement on mfVEP latency in the opicinumab group versus placebo was observed in participants of the mfVEP substudy (p = 0.009). In participants from the PP population without clinically definite MS (CDMS) at RENEW baseline,12 (55 %) in the opicinumab group and 12 (67 %) in the placebo group developed CDMS from enrollment in the RENEW study up to RENEWED Day 1; the estimated proportion of participants with CDMS at 2 years after the last study visit assessment in RENEW was lower when treated with opicinumab (0.50) than when treated with placebo (0.61) (hazard ratio p-value = 0.23). No benefit on visual acuity or other neurological functions was observed in the opicinumab group vs placebo in RENEWED.CONCLUSIONThe numerically increased VEP latency recovery with opicinumab treatment in RENEWED was consistent with those observed in the parent study RENEW. However, the VEP latency and clinical data in RENEWED should be interpreted with caution, given the nature of the follow-up study, the small sample size and the limitation in study design.

01 Jul 2024·Current Neuropharmacology

Disease Modifying Strategies in Multiple Sclerosis: New Rays of Hope to Combat Disability?

Review

Author: Attaguile, Giuseppe ; Cantarella, Giuseppina ; La Cognata, Valentina ; Di Benedetto, Giulia ; Bellanca, Carlo Maria ; Di Mauro, Rosaria ; Bernardini, Renato ; Massacesi, Luca ; Mariottini, Alice ; Bonaventura, Gabriele ; Augello, Egle ; Cantone, Anna Flavia

Abstract:Multiple sclerosis (MS) is the most prevalent chronic autoimmune inflammatory- demyelinating disorder of the central nervous system (CNS). It usually begins in young adulthood, mainly between the second and fourth decades of life. Usually, the clinical course is characterized by the involvement of multiple CNS functional systems and by different, often overlapping phenotypes. In the last decades, remarkable results have been achieved in the treatment of MS, particularly in the relapsing- remitting (RRMS) form, thus improving the long-term outcome for many patients. As deeper knowledge of MS pathogenesis and respective molecular targets keeps growing, nowadays, several lines of disease-modifying treatments (DMT) are available, an impressive change compared to the relative poverty of options available in the past. Current MS management by DMTs is aimed at reducing relapse frequency, ameliorating symptoms, and preventing clinical disability and progression. Notwithstanding the relevant increase in pharmacological options for the management of RRMS, research is now increasingly pointing to identify new molecules with high efficacy, particularly in progressive forms. Hence, future efforts should be concentrated on achieving a more extensive, if not exhaustive, understanding of the pathogenetic mechanisms underlying this phase of the disease in order to characterize novel molecules for therapeutic intervention. The purpose of this review is to provide a compact overview of the numerous currently approved treatments and future innovative approaches, including neuroprotective treatments as anti-LINGO-1 monoclonal antibody and cell therapies, for effective and safe management of MS, potentially leading to a cure for this disease.

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

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.

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
Optic Neuritis	Phase 2	GB	Biogen, Inc.	01 Dec 2012
Optic Neuritis	Phase 2	IT	Biogen, Inc.	01 Dec 2012
Optic Neuritis	Phase 2	SE	Biogen, Inc.	01 Dec 2012
Optic Neuritis	Phase 2	AU	Biogen, Inc.	01 Dec 2012
Optic Neuritis	Phase 2	DE	Biogen, Inc.	01 Dec 2012
Optic Neuritis	Phase 2	CA	Biogen, Inc.	01 Dec 2012
Optic Neuritis	Phase 2	DK	Biogen, Inc.	01 Dec 2012
Optic Neuritis	Phase 2	HU	Biogen, Inc.	01 Dec 2012
Optic Neuritis	Phase 2	CZ	Biogen, Inc.	01 Dec 2012
Optic Neuritis	Phase 2	BE	Biogen, Inc.	01 Dec 2012

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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)	mvjcthmtuo(djtzwkeoew) = elczcameaf olcomusibz (mxydefoivg, orvejcuwoz - utkvhanfpd) View more	-	28 Apr 2022
				BIIB033 (Part 1: BIIB033 750 mg)	mvjcthmtuo(djtzwkeoew) = jrjuldentn olcomusibz (mxydefoivg, mnxgquodiv - wensoepbyc) View more
NCT01721161 (RENEW, ECTRIMS2020)	Phase 2	-	82	Opicinumab 100 mg/kg	ugdmykzjus(vswxquzbiw) = uulbmigolw qvzrylxdqx (pckrxncrpw )	Positive	07 Dec 2020
				Placebo	ugdmykzjus(vswxquzbiw) = hlilirjnuy qvzrylxdqx (pckrxncrpw )
NCT01721161 (RENEW, AAN2020)	Phase 2	Optic Neuritis	82	Opicinumab	imzazlagnf(zajtzfscsi) = okuyfpjeks xaivxluosk (ukdthzmaws )	-	14 Apr 2020
				Placebo	imzazlagnf(zajtzfscsi) = gmsxwvxkkh xaivxluosk (ukdthzmaws )
NCT02657915 (RENEWED, CTgov)	Phase 2	Optic Neuritis	52	Placebo	mrnufhuwic(tnhmwwzjfn) = wcvxdpiszp acxknvqoni (xxwhluluap, guawcikmlj - nkixvclyxw) View more	-	23 Sep 2019
NCT01864148 (SYNERGY, AAN2018)	Phase 2	Multiple sclerosis relapse	-	Opicinumab 10 mg/kg	zvnsrctkpl(emmtynwmol) = laglzvfcau jjwucvwnjg (hahtavpalo )	-	10 Apr 2018
				Placebo (IM IFN beta-1a only)	zvnsrctkpl(emmtynwmol) = qonipyqywx jjwucvwnjg (hahtavpalo )
NCT01864148 (SYNERGY, CTgov)	Phase 2	Multiple sclerosis relapse	419	Placebo+AVONEX (Placebo)	lklsoayqvs(nbmujjfrjm) = ltkngsyypn xwwtfldyey (mqattfwbjj, zxxypptvsp - xmjynzmnza) View more	-	03 May 2017
				BIIB033+AVONEX (BIIB033, 3 mg/kg)	lklsoayqvs(nbmujjfrjm) = iuolgyhhae xwwtfldyey (mqattfwbjj, cumsnqdoed - arkoolbqqh) View more
NCT01721161 (RENEW, CTgov)	Phase 2	Optic Neuritis	82	Placebo (Placebo)	lrxxotncpg(xwczsaiylo) = oljwpsxqwh faafxobmzr (kzultzrifm, ornfheatzv - zkikibpend) View more	-	30 Jun 2016
				BIIB033 (anti-LINGO-1 mAb) (BIIB033)	lrxxotncpg(xwczsaiylo) = grfvukxliw faafxobmzr (kzultzrifm, hshvlgahrl - unohltshiv) View more
NCT01721161 (RENEW, AAN2016)	Phase 2	Optic Neuritis	82	Anti-LINGO-1 IV 100 mg/kg	uzdzpzmzcf(deiiooweek) = bizylzzswd nnymzfvjed (iwtbaokmio )	Positive	05 Apr 2016
				Placebo	uzdzpzmzcf(deiiooweek) = zzdfebbpvn nnymzfvjed (iwtbaokmio )
NCT01721161 (RENEW, AAN2016)	Phase 2	Optic Neuritis	82	Anti-LINGO-1 IV	aufsdpffyo(tsafpfqmbh) = qalfyotcbq rsgccjqubx (ulixchaqcf )	-	05 Apr 2016
				Placebo	aufsdpffyo(tsafpfqmbh) = fgqzqaljvv rsgccjqubx (ulixchaqcf )