Ivlizi (divozilimab) / Biocad - LARVOL DELTA

Predicting Outcomes and Estimating Minimum Sample Sizes for Divozilimab Efficacy in NMOSD: A Clinical Trial Simulation and Unanchored Matching-Adjusted Indirect Comparison (ISPOR-EU 2025) - "Simulation modelling predicts the 6-month ARR of 0.116 (90% CI: 0.030; 0.212) for Divozilimab, corresponding to ARR of 0.117 (90% CI: 0.050; 0.315) versus placebo. A minimum sample size of 35 patients receiving Divozilimab is predicted to provide ≥90% power to demonstrate superiority based on the primary objective."

Biomarker • Clinical • CNS Disorders • Immunology • Neuromyelitis Optica Spectrum Disorder • Rare Diseases • IL2RG

The Ministry of Health expanded the indications of Biocad’s Ivlizi (GxP News) - "Ivlizi, developed by the Russian company Biocad, is now allowed to be used in the treatment of Neuromyelitis optica, also called Devic’s disease, the manufacturer’s press service told GxP News....A clinical trial of Ivlizi with the participation of patients aged 18 to 76 years from Russia and Belarus showed a decrease in the intensity of the disease and the absence of exacerbations for 6 months in 90% of them, the company said."

Approval • Neuromyelitis Optica Spectrum Disorder

EFFICACY AND SAFETY OF DIVOZILIMAB, A NOVEL ANTI-CD20 MONOCLONAL ANTIBODY, IN REAL-WORLD CLINICAL PRACTICE (WCN 2025) - "These findings suggest that Divozilimab is both effective and safe for managing aggressive MS in real-world clinical settings. Further research with larger cohorts and longer follow-up periods is warranted to confirm these results and explore the long-term benefits and safety profile of Divozilimab."

Clinical • Real-world • Real-world evidence • CNS Disorders • CD20

Efficacy and Safety of Divozilimab, a Novel Anti-CD20 Monoclonal Antibody, in Real Clinical Practice (ECTRIMS 2025) - "These findings suggest that Divozilimab is both effective and safe for managing aggressive MS in real-world clinical settings. Further research with larger cohorts and longer follow-up periods is warranted to confirm these results and explore the long-term benefits and safety profile of Divozilimab."

Clinical • CNS Disorders • Multiple Sclerosis • CD20

Long-term Efficacy and Safety of Divozilimab in Patients with Relapsing Multiple Sclerosis: Results of BCD-132-EXT Trial (ECTRIMS 2025) - "Treatment with DIV for 4 years provides sustained long-term efficacy in patients with RMS. Safety profile of DIV was favorable and consistent with the previous studies."

Clinical • CNS Disorders • Multiple Sclerosis • IL2RG

Safety, Pharmacokinetics, Immunogenicity BCD-256-1 and Divozilimab in Subjects With Systemic Lupus Erythematosus (clinicaltrials.gov) - P1 | N=135 | Recruiting | Sponsor: Biocad

Monotherapy • New P1 trial • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Results of 4 years of therapy with divozilimab in patients with relapsing multiple sclerosis (PubMed, Zh Nevrol Psikhiatr Im S S Korsakova) - "The obtained results indicate the maintenance of efficacy over 4 years of therapy with divozilimab. The safety profile of divozilimab was favorable and consistent with previously obtained data."

Journal • CNS Disorders • Multiple Sclerosis • IL2RG

LIBERIUS: Clinical Study of Divozilimab in Patients With Systemic Scleroderma (clinicaltrials.gov) - P3 | N=152 | Active, not recruiting | Sponsor: Biocad | Trial completion date: Feb 2026 ➔ Feb 2027

Trial completion date • Immunology • Scleroderma • Systemic Sclerosis

An Extension Clinical Study of the Efficacy and Safety of BCD-132 in Patients With Multiple Sclerosis Who Previously Received Therapy in Clinical Studies of JSC BIOCAD (clinicaltrials.gov) - P3 | N=44 | Completed | Sponsor: Biocad

New P3 trial • CNS Disorders • Multiple Sclerosis

Comparing the efficacy of divozilimab and second-line treatments for relapsing-remitting multiple sclerosis in the Russian Federation: a systematic review and network meta-analysis (PubMed, Zh Nevrol Psikhiatr Im S S Korsakova) - "Systematic literature review and network meta-analysis revealed statistically significant superiority of divozilimab over cladribine and fingolimod and absence of statistically significant differences with alemtuzumab, ocrelizumab, ofatumumab and natalizumab in the annual relapse rate during 2 years of treatment."

Clinical • Journal • Retrospective data • Review • CNS Disorders • Multiple Sclerosis

Comparative Study of the Efficacy and Safety of BCD-132 With Teriflunomide and Placebo in Multiple Sclerosis (clinicaltrials.gov) - P2 | N=271 | Completed | Sponsor: Biocad | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Multiple Sclerosis

MIRANTIBUS: An International, Multicenter, Randomized, Double-Blind, Double-Masked Study of the Efficacy and Safety of BCD-132 (JSC BIOCAD, Russia) Using an Active Reference Drug (Teriflunomide) for the Treatment of Patients With Multiple Sclerosis (clinicaltrials.gov) - P3 | N=336 | Completed | Sponsor: Biocad | Recruiting ➔ Completed

Trial completion • CNS Disorders • Multiple Sclerosis

LIBERIUS: Clinical Study of Divozilimab in Patients With Systemic Scleroderma (clinicaltrials.gov) - P3 | N=152 | Active, not recruiting | Sponsor: Biocad | Recruiting ➔ Active, not recruiting | Trial completion date: Feb 2025 ➔ Feb 2026

Enrollment closed • Trial completion date • Immunology • Scleroderma • Systemic Sclerosis

Efficacy and Safety of Divozilimab in Patients With Neuromyelitis Optica Spectrum Disorders (AQUARELLE) (clinicaltrials.gov) - P3 | N=105 | Active, not recruiting | Sponsor: Biocad | Recruiting ➔ Active, not recruiting | Trial completion date: Apr 2025 ➔ Sep 2026 | Trial primary completion date: Sep 2024 ➔ Jan 2025

Enrollment closed • Trial completion date • Trial primary completion date • CNS Disorders • Neuromyelitis Optica Spectrum Disorder • Rare Diseases

Recent Advances in the Treatment of Neuromyelitis Optica Spectrum Disorder (ANA 2024) - " A total of 18 clinical trials investigating 17 potential treatments for NMO which include 2 studies on BAT4406F and one study on each of the following: ublituximab, efgartigimod, divozilimab, orelautinib, ofatumumab, zanuutinib, daratumumab, TACI-antibody fusion protein injection (RC18),MIL62, ravulizumab, chimeric antigen receptor (CAR) T cell therapy, B001, edralutinib, baricitinib, belimumab and mitoxantrone. Since the etiology of NMO is multifactorial, inflammation, demyelination, and neuronal death should be considered while investigating new therapies to prevent relapse-related disability."

CNS Disorders

Antibodies to watch in 2024. (PubMed, MAbs) - "In this installment, we discuss key details for 16 antibody therapeutics granted a first approval in 2023, as of November 17 (lecanemab (Leqembi), rozanolixizumab (RYSTIGGO), pozelimab (VEOPOZ), mirikizumab (Omvoh), talquetamab (Talvey), elranatamab (Elrexfio), epcoritamab (EPKINLY), glofitamab (COLUMVI), retifanlimab (Zynyz), concizumab (Alhemo), lebrikizumab (EBGLYSS), tafolecimab (SINTBILO), narlumosbart (Jinlitai), zuberitamab (Enrexib), adebrelimab (Arelili), and divozilimab (Ivlizi))...These nearly 50 product candidates include numerous innovative bispecific antibodies, such as odronextamab, ivonescimab, linvoseltamab, zenocutuzumab, and erfonrilimab, and antibody-drug conjugates, such as trastuzumab botidotin, patritumab deruxtecan, datopotamab deruxtecan, and MRG002, as well as a mixture of two immunocytokines (bifikafusp alfa and onfekafusp alfa)...Our analyses indicate that these molecules have approval success rates in the range of 14-32%, with higher rates..."

Journal • Infectious Disease • Novel Coronavirus Disease • Oncology • Respiratory Diseases

The first experience with the use of divozilimab in the treatment of multiple sclerosis patients in daily clinical practice (PubMed, Zh Nevrol Psikhiatr Im S S Korsakova) - "The data from post-registration use of divozilimab confirm the results of clinical trials, showing high efficacy of the drug with a predictable and favorable safety profile."

Journal • CNS Disorders • Multiple Sclerosis • IL2RG

Long-term efficacy and safety of divozilimab during 2-year treatment of multiple sclerosis patients in randomized double-blind placebo-controlled clinical trial BCD-132-4/MIRANTIBUS (PubMed, Zh Nevrol Psikhiatr Im S S Korsakova) - P3 | "The results of the BCD-132-4/MIRANTIBUS CT indicate a high sustained efficacy and safety of long-term use of DIV in comparison with TRF during 2 years of therapy."

Clinical • Journal • CNS Disorders • Multiple Sclerosis • IL2RG

Key characteristics of anti-CD20 monoclonal antibodies and clinical implications for multiple sclerosis treatment. (PubMed, J Neurol) - "Rituximab, ocrelizumab, ofatumumab, ublituximab and BCD-132 are anti-CD20 therapies that are either undergoing clinical development, or have been approved, for the treatment of MS...By using clinical trial data and real-world evidence, we discuss their mechanisms of action, routes of administration, efficacy (in relation to B-cell kinetics), safety, tolerability and convenience of use. Clinicians, alongside patients and their families, should consider the aspects discussed in this review as part of shared decision-making discussions to improve outcomes and health-related quality of life for people living with MS."

Journal • Review • CNS Disorders • Multiple Sclerosis • IL2RG

Phase III MIRANTIBUS trial: results of 48 weeks treatment with divozilimab versus teriflunomide in relapsing multiple sclerosis. (MSMilan 2023) - "Based on the results of 48-weeks treatment, DIV is more effective than TRF in RMS. DIV has an acceptable safety profile."

P3 data • CNS Disorders • Multiple Sclerosis

Efficacy and safety of antiCD20 monoclonal antibody divozilimab during 48-week treatment of multiple sclerosis patients in randomized double-blind placebo-controlled clinical trial BCD-132-4/MIRANTIBUS (PubMed, Zh Nevrol Psikhiatr Im S S Korsakova) - "The results of the clinical study indicate the high efficacy and safety of DIV in comparison with TRF."

Clinical • Journal • CNS Disorders • Multiple Sclerosis • IL2RG

Efficacy and safety of divozilimab during 24-week treatment of multiple sclerosis patients in randomized double-blind placebo-controlled clinical trial BCD-132-2 (PubMed, Zh Nevrol Psikhiatr Im S S Korsakova) - "Thus, the assessment of 24 weeks treatment demonstrated that DIV is a highly effective, safe and convenient option for the treatment of RRMS patients, both naive and previously treated with disease modifying therapy. A dose of 500 mg is recommended for further efficacy and safety evaluation during phase 3 CT."

Clinical • Journal • P2 data • CNS Disorders • Multiple Sclerosis • CD19 • CD27

Efficacy and Safety of Divozilimab in Patients With Neuromyelitis Optica Spectrum Disorders (AQUARELLE) (clinicaltrials.gov) - P3 | N=105 | Recruiting | Sponsor: Biocad

New P3 trial • CNS Disorders • Neuromyelitis Optica Spectrum Disorder • Rare Diseases • CD19

LIBERIUS: Clinical Study of Divozilimab in Patients With Systemic Scleroderma (clinicaltrials.gov) - P3 | N=152 | Recruiting | Sponsor: Biocad

New P3 trial • Fibrosis • Immunology • Scleroderma • Systemic Sclerosis

New opportunities in the treatment of patients with multiple sclerosis (Resolution of the Council of Experts on April 23, 2022, Moscow, JSC «BIOCAD») (PubMed, Zh Nevrol Psikhiatr Im S S Korsakova) - "These are original, patent-protected drugs that act on known biological targets, improved or modified in structure and mechanism of action compared to existing, successfully proven medicine. The article presents the results of an expert council on the management of patients with multiple sclerosis and the place of new original medicines of the JSC BIOCAD company (SamPEG-IFN-β1a and divozilimab) in multiple sclerosis therapy algorithm."

Journal • CNS Disorders • Multiple Sclerosis • IFNB1