Efleira (netakimab) / Biocad - LARVOL DELTA

Evaluate the Efficacy, Safety, and Pharmacokinetic Profile and Immunogenicity of Subcutaneous Netakimab in Chinese Adult Patients With Active Ankylosing Spondylitis (clinicaltrials.gov) - P3 | N=113 | Completed | Sponsor: SPH-BIOCAD (HK) Limited

New P3 trial • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Efficacy and Safety of Biologics to Treat Adults With Active Radiographic Axial Spondyloarthritis: Systematic Review and Bayesian Network Meta-Analysis (ISPOR-EU 2025) - "OBJECTIVES: To compare efficacy and safety of IL-17 inhibitors in the treatment of adults with active radiographic axial spondyloarthritis (r-AxSpA) over a 16-week period using network meta-analysis (NMA). We conducted systematic literature search in PubMed and Embase in November 2024 to retrieve publications with results of randomized controlled trials (RCTs) evaluating efficacy and safety of IL-17 inhibitors (netakimab, secukinumab, ixekizumab, bimekizumab, brodalumab, xeligekimab, vunakizumab) in adults with active r-AxSpA... Netakimab showed the highest relative efficacy among available IL-17 inhibitors used to treat adults with active r-AxSpA over 16-week horizon and demonstrated a favorable safety profile."

Retrospective data • Review • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Seronegative Spondyloarthropathies • Spondylarthritis • IL17A

Risk of developing a fungal nail infection during therapy with biologic drugs (EADV 2025) - "Fungal infection of the toenails (Tr.rubrum) was detected in 12 patients (10%) receiving topical and phototherapy, in 8 patients (13%) receiving methotrexate, and in 4 patients (9%) receiving a course netakimab. Fungal nail infection was not detected in patients receiving guselkumab and ixekizumab... Biologic therapy of psoriasis does not increase the risk of fungal nail infection. The rates of fungal nail infection detection during biologic therapy of psoriasis do not exceed the similar rates in other methods of therapy."

Dermatology • Immunology • Infectious Disease • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Efficacy of Netakimab in patients with moderate-to-severe plaque psoriasis stratified by BMI: a post-hoc analysis from the phase III PLANETA study (EADV 2025) - "The results of the post-hoc analysis showed that patients with moderate-to-severe plaque psoriasis with BMI<30 and BMI≥30 differed by demographic characteristics, but were mostly comparable by disease characteristics. NTK demonstrated efficacy and safety vs placebo regardless of patients' BMI. Table 1."

Clinical • P3 data • Retrospective data • Ankylosing Spondylitis • Dermatology • Genetic Disorders • Immunology • Infectious Disease • Inflammatory Arthritis • Obesity • Pneumonia • Psoriasis • Psoriatic Arthritis • Respiratory Diseases • Rheumatology • Seronegative Spondyloarthropathies • IL17A

Comprehensive Insights into Psoriasis: Pathophysiology, An Advanced Exploration of Current Landscape and Future Prospects in "Therapeutic Strategies". (PubMed, Recent Adv Inflamm Allergy Drug Discov) - "The focus extends to emerging targeted drugs, such as netakimab, which functions as an interleukin-17 blocker, currently undergoing clinical trials for psoriasis treatment. By synthesizing the latest research findings, this article aims to contribute to the knowledge base surrounding psoriasis, offering clinicians and researchers valuable insights into the evolving landscape of psoriasis treatment modalities."

Journal • Review • Dermatology • Immunology • Oncology • Psoriasis • IL23A

ASTERA: International Multicenter Comparative Randomized Placebo-controlled Clinical Study of Efficacy and Safety of BCD-085 in Patients With Ankylosing Spondylitis (clinicaltrials.gov) - P3 | N=228 | Completed | Sponsor: Biocad | Active, not recruiting ➔ Completed

Trial completion • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies

PATERA: Clinical Study of Efficacy and Safety of BCD-085 (Monoclonal Anti-IL-17 Antibody) in Psoriatic Arthritis (clinicaltrials.gov) - P3 | N=194 | Completed | Sponsor: Biocad | Active, not recruiting ➔ Completed

Trial completion • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

PLANETA-KIDS: Study of the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of Netakimab in Children With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P3 | N=140 | Active, not recruiting | Sponsor: Biocad | Recruiting ➔ Active, not recruiting

Enrollment closed • Dermatology • Immunology • Psoriasis

Biocad will study the efficacy of a psoriasis drug in children over 6 years of age (GxP News) - "The Russian biotech company Biocad has finished recruiting patients for a clinical trial of its drug, netakimab. The manufacturer’s press service told GxP News that the company plans to evaluate the drug’s effectiveness and safety in treating psoriasis in children aged six to 12."

Enrollment closed • Immunology • Psoriasis

To Evaluate the Efficacy and Safety of Netakimab in Chinese Patients With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P3 | N=202 | Active, not recruiting | Sponsor: SPH-BIOCAD (HK) Limited

New P3 trial • Dermatology • Immunology • Psoriasis

Efficacy and Safety of IL-17 and JAK Inhibitors in Ankylosing Spondylitis: A Systematic Review and Network Meta-Analysis. (PubMed, Int Arch Allergy Immunol) - "The results of the network meta-analysis showed that netakimab 120mg ranked relatively high in outcome of ASAS20 and ASAS40. All treatments with IL-17 and JAK inhibitors were generally safe and well tolerated. However, the two included netakimab clinical studies may have limitations. Therefore, the therapeutic agents should be carefully selected in clinical treatment. Moreover, the efficacy and safety of netakimab remain to be further analyzed in studies with larger sample sizes and longer follow-up times."

Journal • Retrospective data • Review • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL17A

Next-Generation Anti-IL-17 Agents for Psoriatic Disease: A Pipeline Review. (PubMed, Am J Clin Dermatol) - "Key agents under investigation include netakimab, vunakizumab, xeligekimab, gumokimab, HB0017, CJM 112, JS005, 608, LZM012, ZL-1102, izokibep, sonelokimab, DC-806, DC-853, and LEO 153339. Both preclinical and clinical trial data for each agent are summarized, with an emphasis on their efficacy, adverse effects, immunogenicity, and future outlooks."

Journal • Dermatology • Immunology • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Interleukin-17: A pleiotropic cytokine implicated in inflammatory, infectious, and malignant disorders. (PubMed, Cytokine Growth Factor Rev) - "Four FDA-approved drugs-secukinumab (for ankylosing spondylitis, enthesitis-related arthritis, hidradenitis suppurativa, non-radiographic axial spondyloarthritis, plaque psoriasis, and psoriatic arthritis), ixekizumab (for ankylosing spondylitis, non-radiographic axial spondyloarthritis, plaque psoriasis, and psoriatic arthritis), brodalumab (for plaque psoriasis), and bimekizumab (for plaque psoriasis)-suppress the IL-17 pathway, with more in development, including netakimab, sonelokimab, izokibep, and CJM112. These agents and others are being studied across a spectrum of disorders. Understanding the complicated interplay between IL-17 and other immune mediators may yield new treatments for inflammatory/autoimmune conditions and malignancies."

Journal • Ankylosing Spondylitis • Dermatology • Genetic Disorders • Hidradenitis Suppurativa • Idiopathic Arthritis • Immunology • Infectious Disease • Inflammatory Arthritis • Oncology • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Skin Cancer • Solid Tumor • Spondylarthritis • IL17A • IL17C • IL17RA • IL23A

PLANETA-KIDS: Study of the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of Netakimab in Children with Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P3 | N=140 | Recruiting | Sponsor: Biocad

New P3 trial • Dermatology • Immunology • Psoriasis

Successful intra-class switching to novel IL-17 inhibitor netakimab in patients with plaque psoriasis in real-world practice (EADV 2024) - "This prospective, real-world study demonstrated that switching to NTK after previous ineffectiveness of other IL- 17i is a promising strategy, resulting in durable responses in the majority of patients and an improvement in quality of life."

Clinical • Real-world • Real-world evidence • Ankylosing Spondylitis • Dermatology • Immunology • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL17A

Efficacy and Safety of Netakimab Through 3 Years in Moderate-to-Severe Psoriasis: Long-Term Results from the PLANETA Phase-3 Randomized Controlled Trial (EADV 2024) - P3 | "The results demonstrate NTK 120 mg maintains long-term efficacy and favorable safety profile in patients with moderate-to-severe plaque psoriasis through 3 years of treatment. Figure 1. PASI75/PASI90/PASI100 response rate during the long-term extension period (n=147) Figure 2."

Clinical • P3 data • Dermatology • Diabetes • Hematological Disorders • Hepatology • Immunology • Infectious Disease • Leukopenia • Neutropenia • Novel Coronavirus Disease • Pneumonia • Psoriasis • Respiratory Diseases • IL17A

Real-World Retention Rate, Effectiveness, and Safety of Netakimab in the Treatment of Patients with Ankylosing Spondylitis: First Year Results of the LIBRA Post-Registration Safety Study. (PubMed, Dokl Biochem Biophys) - ": In real-world clinical practice, netakimab demonstrated high retention rates, a favorable safety profile, and sustained efficacy throughout the first year of therapy."

Clinical • Journal • Real-world • Real-world evidence • Ankylosing Spondylitis • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Course of Uveitis in Patients with Ankylosing Spondylitis during the Interleukin17 Inhibitors Therapy. (PubMed, Dokl Biochem Biophys) - "The study involved 73 patients with AS (New York criteria, 1984), who received IL17-i (57-secukinumab (SEC), 22-netakimab (NTK)) for at least 1 year. There were no significant differences in the incidence rates of uveitis during IL17-i therapy compared with non-biological therapy. IL17-i therapy have not demonstrated a significant effect on the course of uveitis in AS in the study group."

Journal • Ankylosing Spondylitis • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Ocular Inflammation • Ophthalmology • Psoriasis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Uveitis • IL17A • IL7

Current treatment for spondyloarthritis: focus on netakimab. A review (PubMed, Ter Arkh) - "The drug has low immunogenicity, which allows us to count on the possibility of many years of effective use. Resolutions of expert councils on the use of NTK in AS and PsA support the inclusion of this drug in clinical guidelines."

Clinical • Journal • Review • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • IL17A

Real-world experience with netakimab in the treatment of spondyloarthritis (PubMed, Ter Arkh) - "The obtained data confirm the effectiveness and safety of netakimab in treating AS and PsA in real-world practice."

Journal • Real-world • Real-world evidence • Retrospective data • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • CRP

NEUROPROTECTIVE AND ANTIOXIDANT POTENTIAL OF MONTELUKAST-ACETYLCYSTEINE COMBINATION THERAPY FOR BRAIN PROTECTION IN PATIENTS WITH COVID-19 INDUCED PNEUMONIA. (PubMed, Georgian Med News) - "No patient in Group 3 received JAK inhibitors (tofacitinib and baricitinib), IL-6 (olokizumab), IL-17A (netakimab) and glucocorticosteroids, however, recovery rates were completely good. Thus, based on the data given, it can be concluded that the high efficacy of the acetylcysteine/montelukast combination (as neuroprotectors) in pneumonia caused by COVID-19 is due to the effect of drugs on key mechanisms of pathogenesis: reduction of oxidative stress as drugs (combination) ensuring the free radical scavenging; stimulation of glutathione synthesis; suppression of cytokine storm; reduction of bronchospasm, mucus secretion and airway edema; lowering of BBB permeability and the ability to improve cerebral microcirculatory perfusion in the presence of antiplatelet agents. In conclusion, the combination of montelukast and acetylcysteine may provide an effective, safe, multicomponent approach to the prevention of hypoxic brain injury in patients with COVID-19 pneumonia."

Combination therapy • Journal • Acute Respiratory Distress Syndrome • Cardiovascular • CNS Disorders • Coronary Artery Disease • Diabetes • Heart Failure • Hematological Disorders • Hypertension • Infectious Disease • Leukopenia • Mental Retardation • Metabolic Disorders • Novel Coronavirus Disease • Oncology • Pneumonia • Psychiatry • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • Tuberculosis • Type 2 Diabetes Mellitus • Vascular Neurology • IL17A • IL6 • TNFA

ASTERA: International Multicenter Comparative Randomized Placebo-controlled Clinical Study of Efficacy and Safety of BCD-085 in Patients With Ankylosing Spondylitis (clinicaltrials.gov) - P3 | N=228 | Active, not recruiting | Sponsor: Biocad | Trial completion date: Mar 2022 ➔ Apr 2023

Trial completion date • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Two Epitope Regions Revealed in the Complex of IL-17A and Anti-IL-17A VH Domain. (PubMed, Int J Mol Sci) - "Netakimab is an IL-17A-specific antibody containing a Lama glama VH derivative domain and a VL variable domain...The β-turn of IL-17A, which forms the so-called epitope-1, appears to be the main region of IL-17A interaction with the antibody. Contacts formed by the IL-17A mobile C-terminal region residues (epitope-2) further stabilize the antibody-antigen complex."

Journal • CNS Disorders • Dermatology • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Multiple Sclerosis • Psoriasis • Rheumatoid Arthritis • Rheumatology • Systemic Lupus Erythematosus • IL17A

Efficacy of Targeted Drugs for the Treatment of Adults With Moderate-to-Severe Plaque Psoriasis in the Russian Federation: A Systematic Literature Review Update (ISPOR-EU 2022) - "Evidence synthesis included RCTs evaluating the efficacy of adalimumab (ADA), infliximab (INF), etanercept (ETN), certolizumab pegol (CZP), ixekizumab (IXE), netakimab (NTK), secukinumab (SEC), risankizumab (RIS), guselkumab (GUS), ustekinumab (UST), tofacitinib (TOFA), and apremilast (APR) after 12 weeks of therapy. The addition of head-to-head trials and increased statistical power of the network revealed previously unidentified significant differences between treatment options for moderate-to-severe plaque psoriasis."

Clinical • Review • Dermatology • Immunology • Oncology • Psoriasis • IL12A • IL17A • IL23A

Efficacy of Targeted Drugs for the Treatment of Adults With Moderate-to-Severe Plaque Psoriasis in the Russian Federation: Number Needed to Treat and Costs Per Responder (ISPOR-EU 2022) - "OBJECTIVES: To reassess the number of adults with moderate-to-severe plaque psoriasis needed to treat (NNT) to achieve one Psoriasis Area and Severity Index (PASI) 75/90 response and costs per responder (CpR) after 12 weeks for adalimumab (ADA), infliximab (INF), etanercept (ETN), ixekizumab (IXE), netakimab (NTK), secukinumab (SEC), ustekinumab (UST), tofacitinib (TOFA), and apremilast (APR) and after 16 weeks for certolizumab pegol (CZP), risankizumab (RIS) and guselkumab (GUS) and 1 year of therapy for each drug analyzed. This study complements the systematic review and meta-analysis of the efficacy of targeted drugs to treat adults with moderate-to-severe plaque psoriasis in the Russian Federation. The results may become a useful tool for treatment decision-making."

Clinical • Dermatology • Immunology • Oncology • Psoriasis • IL17A • IL23A