opicinumab (BIIB033) / Biogen - LARVOL DELTA

Investigating Opicinumab's Impact on Myelin-Weighted Brain Networks in MS (ECTRIMS 2025) - P2 | "Our findings demonstrate that MySD-Lesion is an innovative approach to studying tract and network-based changes following the administration of remyelinating drugs. This framework paves the way for future clinical trials assessing therapies fostering remyelination."

Interventions promoting remyelination in multiple sclerosis: a systematic review of clinical trials. (PubMed, Neurol Res) - "Notably, rHIgM22, L-T3, opicinumab, clemastine fumarate, phenonytoin, domperidone, GSK239512, human fetal neural precursor cells (hfNPCs), and low-intensity repetitive transcranial magnetic stimulation (LI-rTMS) exhibited remyelination potential. Additionally, disease-modifying therapies (DMTs) such as Ocrelizumab, Fingolimod, and Natalizumab showed promising effects. Although several interventions demonstrated remyelination potential, limitations such as small sample sizes, short follow-up periods, and lack of standardized clinical endpoints validating remyelination's functional impact, highlight the need for robust clinical trial designs, advanced biomarkers, and combination therapies integrating remyelination, neuroprotection, and immunomodulation to improve MS treatment outcomes."

Journal • Review • CNS Disorders • Immunology • Inflammation • Multiple Sclerosis

RENEWED: A follow-up study of the opicinumab phase 2 RENEW study in participants with acute optic neuritis. (PubMed, Mult Scler Relat Disord) - P2 | "The 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."

Journal • P2 data • CNS Disorders • Multiple Sclerosis • Ocular Inflammation • Ophthalmology • Optic Neuritis

Lesion-level correspondence and longitudinal properties of paramagnetic rim and slowly expanding lesions in multiple sclerosis. (PubMed, Mult Scler) - P2 | "MRIs were analyzed from a substudy of AFFINITY [NCT03222973], a phase 2 trial of opicinumab in relapsing MS...Chronic MS lesions identified as both PRL and SEL were associated with the most severe accumulation of tissue damage. AFFINITY [NCT03222973]."

Journal • CNS Disorders • Multiple Sclerosis

Novel Drugs in a Pipeline for Progressive Multiple Sclerosis. (PubMed, J Clin Med) - "Therefore, the efficacy of available anti-inflammatory drugs approved for the treatment of PMS, such as ocrelizumab or siponimod, is limited in time. In search of innovative solutions, several research studies have been conducted to evaluate the effectiveness of drugs with neuroprotective or remyelinating effects in PMS, including biotin, ibudilast, simvastatin, alpha-lipoic acid, clemastine, amiloride, fluoxetine, riluzole, masitinib, opicinumab, and lamotrigine. The current review includes those compounds, which have entered the clinical phase of assessment, and the authors discuss future prospects for successful PMS treatment."

Journal • Review • CNS Disorders • Multiple Sclerosis

Optic neuritis: aetiopathogenesis, diagnosis, prognosis and management (PubMed, Rev Neurol) - "Some of these drugs, such as opicinumab, clemastine, phenytoin or simvastatin, have shown positive results; however, their clinical effect remains to be defined. Plasmapheresis has also been shown to be effective in patients with ON. In this review we will address basic aspects of the management of ON, in the fundamental context of MS, NMOSD and MOGAD, with emphasis on etiopathogenic, diagnostic, prognostic and therapeutic developments."

Journal • Review • CNS Disorders • Multiple Sclerosis • Neuromyelitis Optica Spectrum Disorder • Ocular Inflammation • Ophthalmology • Optic Neuritis • Rare Diseases • Solid Tumor • MRI

Remyelination trial failures: Repercussions of ignoring neurorehabilitation and exercise in repair. (PubMed, Mult Scler Relat Disord) - "Several putative neurorestorative therapies in multiple sclerosis (MS) have recently failed; this includes high-dose biotin, bexarotene, a retinoic acid receptor gamma agonist, and opicinumab (anti-LINGO-1). We also make the case for testing combinations that include other pro-repair interventions such as exercise, Nrf2 inducers and possibly neurostimulation. The MS community can't afford for any more treatments to fail because of poor trial design and ignoring biology."

Journal • Review • CNS Disorders • Multiple Sclerosis • RARG

[VIRTUAL] Efficacy and safety of opicinumab in participants with relapsing multiple sclerosis: a randomized, placebo-controlled, Phase 2 trial (AFFINITY Part 1) (ECTRIMS 2021) - P2 | "The mean differences in ODRS over 72 weeks were 0.13, 0.31, and 0.02 in natalizumab, dimethyl fumarate, and interferon beta subgroups, respectively... The AFFINITY Part 1 did not meet the primary and key secondary efficacy endpoints. Learnings from the AFFINITY study and additional data analyses may inform the design of future remyelination trials. Supported by: Biogen"

Clinical • P2 data • CNS Disorders • Immune Modulation • Inflammation • Multiple Sclerosis • Solid Tumor

"What was the benefit of #opicinumab?" (@DrJim4MS)

Remyelination therapies for multiple sclerosis: Optimizing translation from animal models into clinical trials. (PubMed, Expert Opin Investig Drugs) - "Limiting the contribution of OPC mediated repair in models of MS would allow the evaluation of remyelination-promoting agents on mature oligodendrocytes. Among remyelinating reagents reviewed, only rHIgM22 targets both OPCs and mature oligodendrocytes."

Journal • Preclinical • CNS Disorders • Inflammation • Multiple Sclerosis • Solid Tumor

[VIRTUAL] Retinal Structure and Function as a Predictor of Long-Term Visual Outcomes: A Post Hoc Analysis of RENEW and RENEWED (AAN 2021) - P2 | "Design/ RENEW (NCT01721161) was a randomized, placebo-controlled study of participants with first-episode acute optic neuritis who were treated with opicinumab 100 mg/kg Q4W (6 doses) or placebo and followed-up to week 32 (Wk32)... Changes in the RGCL/IPL and RNFL are predictive of long-term visual outcomes. Supported by: Biogen"

Retrospective data • CNS Disorders

AFFINITY: Efficacy and Safety of BIIB033 (Opicinumab) as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS) (clinicaltrials.gov) - P2; N=263; Terminated; Sponsor: Biogen; Trial completion date: May 2022 ➔ Feb 2021; Active, not recruiting ➔ Terminated; Trial primary completion date: Mar 2022 ➔ Feb 2021; The top-line results from the Part 1 did not meet the pre-specified primary endpoint nor the key secondary endpoints. The decision to discontinue study 215MS202 Part 2 was not based on safety concerns.

Clinical • Trial completion date • Trial primary completion date • Trial termination • CNS Disorders • Inflammation • Multiple Sclerosis

"You're killing me Dr. Singer. I just filmed a video on opicinumab which will now be horribly behind-the-times." (@Brandon_Beaber)

Video

[VIRTUAL] RENEWED:Long-term mfVEP latency outcomes in Participants Previously Enrolled in the Opicinumab Phase 2 Study RENEW. (MSDC 2020) - P2 | "Finally, between the last visit of RENEW study (24 or 32 weeks) and Day 1 of RENEWED study, mfVEP latency demonstrated a trend for better recovery in the opicinumab group vs placebo group (8.4±7.3 and 2.7±5.6 ms respectively, p=0.07, t-test).Conclusions While acknowledging the small sample size of the mfVEP sub-study, the effect of opicinumab on enhanced mfVEP latency recovery was sustained over 2 years ofthe post-treatment period. In addition, a close association between baseline latency delay and degree of latency recovery in opicinumab group suggests that the remyelinating effect of opicinumab treatment may be proportional to the initial degree of demyelination."

P2 data • Ocular Inflammation • Ophthalmology • Optic Neuritis

[VIRTUAL] Baseline MRI lesions as predictors of clinically definite multiple sclerosis: a post hoc analysis of RENEW and RENEWED (MSDC 2020) - P2 | "Background Magnetic resonance imaging (MRI) can supplement clinical diagnostic criteria for multiple sclerosis (MS) by increasing diagnostic sensitivity and predicting the onset of clinically definite MS (CDMS).Objectives To determine whether the number of gadolinium-enhanced (Gd+) lesions and T2 volume at baseline (BL) may be predictors of CDMS.Methods RENEW (NCT01721161) was a randomised, double-blind, placebo-controlled study of participants with a first episode of acute optic neuritis who were treated with opicinumab 100 mg/kg once every 4 weeks (6 doses) and followed-up to week 32...A limitation of this study is its small sample size. Supported by: Biogen"

Clinical • Retrospective data • CNS Disorders • Multiple Sclerosis • Ocular Inflammation • Ophthalmology • Optic Neuritis

"Some of the trials of progressive MS (ibudilast, opicinumab) #MSVirtual2020" (@IlNeuroDoktorMS)

Multiple Sclerosis

"Chaterine Lubetzki over het promoten van remyelinisatie met o.a. medicatie (trials met Opicinumab en Clemastine) en onderzoek naar effect van elektrische simulatie op remyelinisatie #MSvirtual2020 #Ectrims" (@MSwebNL)

"Remyielination!!!?? #BIIB061 #opicinumab @biogen #elezanumab @AbbVieUS #CNMAu8 @CleneNano #Inception5 @Roche @genentech" (@ALFONFX)

Patterning Chronic Active Demyelination in Slowly Expanding/Evolving White Matter MS Lesions. (PubMed, AJNR Am J Neuroradiol) - P2 | "Patterns of longitudinal change in the normalized magnetization transfer ratio and DTI radial diffusivity in slowly expanding/evolving lesions were consistent with progressive demyelination and tissue loss, as seen in smoldering white matter MS plaques."

Journal • CNS Disorders • Multiple Sclerosis

Opicinumab: is it a potential treatment for multiple sclerosis? (PubMed, Ann Transl Med) - No abstract available

Journal • CNS Disorders • Multiple Sclerosis

"@XMontalban qué pot comentar de #opicinumab?... moltes gràcies" (@jporterol)

Biogen Idec to present extensive new data from its robust multiple sclerosis portfolio at ECTRIMS (Reuters) - "Biogen Idec...will present 58 data sets from the company’s multiple sclerosis (MS) clinical portfolio of approved and investigational products at the 29th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)....At ECTRIMS, Biogen Idec will also launch The Multiple Sclerosis Registry Research Fellowship Program, an initiative which solidifies our ongoing commitment to clinical research in order to improve the lives of people living with MS."

Anticipated clinical data • Multiple Sclerosis

Initial Impairment and Recovery of Vision-Related Functioning in Participants With Acute Optic Neuritis From the RENEW Trial of Opicinumab. (PubMed, J Neuroophthalmol) - "Most participants in the RENEW PP population demonstrated substantial recovery from baseline in patient-reported vision-related functioning and HCVA, regardless of treatment and structural damage. Average scores after recovery remained lower than those of published disease-free control groups. These results provide important information on visual function recovery in patients with AON, as measured by NEI-VFQ-25 and NOS-10.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal."

Journal • Ocular Inflammation • Ophthalmology • Optic Neuritis • Solid Tumor

Safety and efficacy of opicinumab in patients with relapsing multiple sclerosis (SYNERGY): a randomised, placebo-controlled, phase 2 trial. (PubMed, Lancet Neurol) - P2 | "Our findings did not show a significant dose-linear improvement in disability compared with placebo in patients with relapsing multiple sclerosis. Further studies are needed to investigate whether some subpopulations identified in the study might benefit from opicinumab treatment at an optimum dose."

Clinical • Journal • P2 data • Bipolar Disorder • CNS Disorders • Immunology • Infectious Disease • Mood Disorders • Multiple Sclerosis • Nephrology • Solid Tumor • Suicidal Ideation

Biogen: positive 2Q15 results for multiple sclerosis pipeline drugs (Yahoo Finance) - "Biogen and collaboration partner AbbVie (ABBV) are currently planning to launch Zinbryta, a new drug for relapsing MS patients. The drug is under regulatory review and is expected to be a strong addition to Biogen’s MS portfolio...Biogen is anticipating Phase 3 results for its existing drug Tysabri, currently treating relapsing remitting multiple sclerosis (or RRMS) and primary progressive multiple sclerosis (or PPMS) patients in the later part of 2015...Biogen is expecting Phase 2 results of anti-LINGO therapy for MS in 2016."

Anticipated launch • Anticipated P2 data • Anticipated P3 data • Multiple Sclerosis