Hutruo (bermekimab IV) / J&J - LARVOL DELTA

Nutrition in cachexia: support by pharmacological options? (DGHO 2025) - "According to initial clinical studies there is a group of particularly promising agents, including: the selective androgen enobosarm, S-pindolol, which has a mixed effect on beta receptors, the central appetite stimulant anamorelin, which has been approved in Japan, the cytokine-blocking substances bermekimab (anti-IL1alpha), tocilizumab (anti-IL6) and ruxolitinib (Jak1/2 inhibitor), the atypical neuroleptic olanzapine and newer GDF-15 antibodies such as ponsegromab. For approval, effects on the spectrum of symptoms, performance and body composition will probably be required."

Anorexia • Cachexia • Fatigue • GDF15 • IL1A

Targeted Biologic Therapies for Hidradenitis Suppurativa. (PubMed, Int J Mol Sci) - "IL-17 inhibitors (secukinumab, bimekizumab) and IL-1 inhibitors (bermekimab, anakinra) demonstrated promising reductions in inflammatory burden and improved quality of life. TNF-α inhibitors, particularly adalimumab and infliximab, consistently achieved HiSCR and HSS improvements. Guselkumab (IL-23) showed limited efficacy in HiSCR but modest pain relief...These findings underscore the therapeutic potential of biologic agents in managing HS. A greater emphasis on biomarker-guided treatment selection and interdisciplinary collaboration is warranted to optimize long-term outcomes for patients."

Journal • Review • Dermatology • Hidradenitis Suppurativa • Immunology • Inflammation • Pain • IL17A • IL23A

New Therapeutic Strategies in Hidradenitis Suppurativa: An Integrative Approach to a Chronic and Debilitating Disease (EADV 2025) - "Conventional treatments include antibiotics (notably tetracyclines and clindamycin-rifampin combinations), systemic retinoids, corticosteroids (systemic or intralesional), and hormonal therapies (anti-androgens and oral contraceptives), particularly for women with mild disease...Adalimumab, an anti-TNF-α agent, is currently the only biologic approved for HS and has demonstrated significant efficacy in phase III trials although with variable long-term outcomes. Other biologics under investigation include infliximab, etanercept, ustekinumab (anti-IL-12/23), and secukinumab (anti-IL-17A), the latter showing rapid clinical improvement when administered biweekly. Moreover, agents such as bimekizumab (dual IL-17A/F inhibitor) and bermekimab (anti-IL-1α) are being evaluated in advanced trials and offer encouraging results...The integration of targeted biologic agents into the therapeutic algorithm represents a significant advancement, particularly for refractory forms of the..."

CNS Disorders • Depression • Dermatology • Genetic Disorders • Hidradenitis Suppurativa • Immunology • Inflammation • Obesity • Pruritus • Psychiatry • IL12A • IL17A • IL1B • IL23A

A Phase 2, Randomized, Placebo-Controlled Study of Bermekimab in Moderate-to-Severe Hidradenitis Suppurativa. (PubMed, J Invest Dermatol) - No abstract available

Journal • P2 data • Dermatology • Hidradenitis Suppurativa • Immunology

Alterations in Arabinogalactan Proteins in Banana Peel during Fruit Development and Ripening. (PubMed, Ann Bot) - "The findings of this study offer new understanding into AGP's role in banana fruit growth and ripening."

Journal

The role of interleukin inhibitors in the treatment of hidradenitis suppurativa; a systematic review of clinical trials. (PubMed, Autoimmun Rev) - "Secukinumab showed sustained hidradenitis Suppurativa Clinical Response (HiSCR) improvements, particularly in biologic-naïve patients with common adverse events (AEs). Bimekizumab was effective with biweekly dosing, while the four-week regimen had inconsistent results, with rare reports of AEs. Brodalumab and bermekimab provided rapid and sustained HiSCR responses with lesion reductions, which were well tolerated. Guselkumab and ustekinumab showed promising but statistically nonsignificant improvements with mild AEs. Risankizumab did not significantly improve HiSCR rates but showed Dermatology Life Quality Index (DLQI) benefits. Anakinra offered moderate efficacy with prolonged exacerbation-free periods but led to some treatment discontinuations. Spesolimab reduced inflammatory lesions and draining tunnels while maintaining a favorable safety profile. IL inhibitors, especially IL-17 inhibitors, have demonstrated efficacy in treating moderate-to-severe HS, while..."

Journal • Review • Dermatology • Hidradenitis Suppurativa • Immunology • Inflammation • IL17A • IL23A

A Systematic Review of Pharmacological Interventions for Hidradenitis Suppurativa: A Focus on Clinical Response, Quality of Life, and Safety (ISPOR-EU 2024) - "Adalimumab, anakinra, apremilast, avacopan, bimekizumab, doxycycline, guselkumab, IFX-1, MABp1, PF-06650833, PF-06700841, PF-06826647, povorcitinib, risankizumab, RIST4721, secukinumab, upadacitinib all reported notable clinical benefits, with Hidradenitis Suppurativa Clinical Response (HiSCR) ranged from 10% (anakinra at week 24) to 88% (povorcitinib-90 mg at week 8)...In contrast, no SAEs were detected in spesolimab or anakinra, while bimekizumab had similar safety profiles to adalimumab. The results of this review demonstrate the possibility of highly personalized treatment approaches for HS management, including adalimumab and povorcitinib. The optimization of HS care requires further research on long-term outcomes."

Clinical • HEOR • Review • Dermatology • Hidradenitis Suppurativa • Immunology • Pain

Report of successful treatment of follicular occlusion triad with adalimumab and research progress on biologic therapy for follicular occlusion triad. (PubMed, J Dermatolog Treat) - "Purpose: This article aims to present a case report of a patient with Follicular occlusion triad (FOT) who achieved successful disease control with adalimumab combined with isotretinoin and provide a comprehensive review of the current research progress on biologic therapies for FOT...The literature review revealed that adalimumab and secukinumab are the two FDA-approved biologics for FOT, while others, such as bimekizumab, infliximab, anakinra, and bermekimab, have shown promise in clinical studies. Biologic therapies have revolutionized FOT management, providing effective options for patients unresponsive to conventional treatments. As our understanding of FOT pathogenesis and the mechanisms of action of biologics grows, further advancements in biologic therapies for FOT are expected."

Journal • Review • Pain • IL12A • IL17A • IL23A

Biologics and Small Molecules for Hidradenitis Suppurativa (HS) (INDERCOS 2024) - " Currently, the only FDA and EMA-approved biologic therapy for moderate to severe HS is Adalimumab. There are also promising biologics in phase III trials such as: anti-IL-17 antibodies, secukinumab, and bimekizumab. Bermekimab, an anti-IL-1 biologic, is currently in phase II trials, and shows encouraging results. New area of treating HS is present. New biologics and small molecules are the future trends during these last years."

Acne Vulgaris • Dermatology • Hidradenitis Suppurativa • Immunology • Inflammation • Pain • IL17A

Therapeutic Potential of IL-1 Antagonism in Hidradenitis Suppurativa. (PubMed, Biomolecules) - "The aim of this narrative review is to describe the pathological dysregulation of IL-1 family members in HS and to provide an update on therapeutic strategies targeting IL-1 family cytokine signaling. Further clinical and preclinical data may likely lead to the enrichment of the therapeutic armamentarium of HS with IL-1 family cytokine antagonists."

Journal • Review • Dermatology • Hidradenitis Suppurativa • Immunology • Inflammation

A randomized clinical trial of bermekimab treatment for clinical improvement of systemic sclerosis. (PubMed, iScience) - "Production of IL-1α and TNF by circulating mononuclear cells was decreased and the absolute count of CD42/Cd62-platelets was decreased. Results suggest that bermekimab is a promising treatment for SSc."

Clinical • Journal • Fibrosis • Immunology • Scleroderma • Systemic Sclerosis • SELP

Computational Drug Discovery in Ankylosing Spondylitis-induced Osteoporosis Based on Data Mining and bioinformatics analysis. (PubMed, World Neurosurg) - "In conclusion, CARLUMAB, BERMEKIMAB, RILONACEPT, RILOTUMUMAB and FICLATUZUMAB were first identified as the potential drugs for the treatment of AS-OP, proving the value of text mining and pathway analysis in drug discovery."

Journal • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Orthopedics • Osteoporosis • Rheumatology • Seronegative Spondyloarthropathies

A Study of JNJ-77474462 (Bermekimab) in Healthy Chinese Participants (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Janssen Research & Development, LLC | N=36 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal

MABp1 to improve clinical outcomes of patients with symptomatic refractory metastatic colorectal cancer patients: Per-protocol population analysis of phase III study (PT026). (ASCO 2017) - P3; "Achieving the primary endpoint was associated with improvement in outcomes, RECIST stabilization, SAEs and survival. Further study should confirm the effect of MABp1 on survival in this population."

Adverse events • Clinical • P3 data • Biosimilar • Colorectal Cancer • Pain

Phase I trial of Bermekimab with nanoliposomal irinotecan and 5-fluorouracil/folinic acid in advanced pancreatic ductal adenocarcinoma (Nature) - P1 | N=22 | NCT03207724 | "3 of 21 patients experienced dose-limiting toxicities attributable to the chemotherapy backbone. 58% (10/17) of patients exhibited weight stability. Physical performance status was preserved among all subjects. Patients reported improvements in quality-of-life metrics via QLQ-PAN26 questioner (−3.6, p = 0.18) and functional well-being (1.78, p = 0.02). Subjects exhibited a decrease in inflammatory cytokines, notably, vascular endothelial growth factor (−0.86, p = 0.017) with Bermekimab."

P1 data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Phase I trial of Bermekimab with nanoliposomal irinotecan and 5-fluorouracil/folinic acid in advanced pancreatic ductal adenocarcinoma. (PubMed, Sci Rep) - P1 | "This was a single-arm, open-label adaptive Bayesian dose-escalation study of Bermekimab combined with Nal-Iri and 5FU/FA in patients with advanced or locally advanced PDAC who failed gemcitabine-based chemotherapy. In sum, Bermekimab is safe to be used in conjunction with Nal-Iri and 5-FU/FA chemotherapy. This benign toxicological profile warrants further Phase I/II investigation of Bermekimab in combinatorial strategies, and the impact of anti-IL-1α antibodies on the gut microbiome.Clinical trials registration: NCT03207724 05/07/2017."

Journal • P1 data • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

Systematic Review of Safety and Efficacy of IL-1-Targeted Biologics in Treating Immune-Mediated Disorders. (PubMed, Front Immunol) - "This systematic review of IL-1-targeting biologics summarizes the current state of research, safety, and clinical efficacy of anakinra, bermekimab, canakinumab, gevokizumab, and rilonacept in treating immune-mediated disorders. https://www.crd.york.ac.uk/PROSPERO/, identifier CRD42021228547."

Review • Cardiovascular • Dermatology • Diabetes • Genetic Disorders • Gout • Graft versus Host Disease • Hidradenitis Suppurativa • Idiopathic Arthritis • Immunology • Inflammation • Inflammatory Arthritis • Metabolic Disorders • Ocular Inflammation • Ophthalmology • Rare Diseases • Rheumatoid Arthritis • Rheumatology • Sjogren's Syndrome • Type 1 Diabetes Mellitus • Uveitis

Biologics and Small Molecule Inhibitors for Treating Hidradenitis Suppurativa: A Systematic Review and Meta-Analysis. (PubMed, Biomedicines) - "Adalimumab and bimekizumab are the only two biologics effective in achieving HiSCR with acceptable safety profile, whereas adalimumab is the only biologic effective in achieving DLQI 0/1."

Journal • Retrospective data • Review • Dermatology • Hidradenitis Suppurativa

New and Emerging Targeted Therapies for Hidradenitis Suppurativa. (PubMed, Int J Mol Sci) - "Adalimumab is currently the only Food and Drug Administration (FDA)- and European Medicines Agency (EMA)-approved biologic therapy for moderate to severe HS in adults and adolescents...Presently, the most promising biologics in phase III trials are anti-IL-17 antibodies, secukinumab, and bimekizumab. Furthermore, an anti-IL-1 biologic, bermekimab, is currently in phase II trials, and shows encouraging results. Overall, the clinical efficacies of all new targeted therapies published up to this point are limited. More studies need to be performed to clarify the precise molecular pathology, and assess the efficacy of biological therapies for HS."

Journal • Review • Dermatology • Hidradenitis Suppurativa • Inflammation • IFNG • IL12A • IL17A

A Study of Bermekimab for the Treatment of Adult Participants With Moderate-to-Severe Atopic Dermatitis (clinicaltrials.gov) - P2a | N=6 | Terminated | Sponsor: Janssen Research & Development, LLC | N=60 ➔ 6 | Trial completion date: Dec 2022 ➔ Mar 2022 | Recruiting ➔ Terminated | Trial primary completion date: Oct 2022 ➔ Mar 2022; Premature study termination (efficacy)

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Study of JNJ-77474462 (Bermekimab) in Healthy Chinese Participants (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Oct 2022 ➔ Nov 2023 | Initiation date: Mar 2022 ➔ May 2023 | Trial primary completion date: Oct 2022 ➔ Nov 2023

Trial completion date • Trial initiation date • Trial primary completion date

A Study of JNJ-77474462 (Bermekimab) in Healthy Chinese Participants (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Janssen Research & Development, LLC

New P1 trial

Transport study of interleukin-1 inhibitors using a human in vitro model of the blood-brain barrier. (PubMed, Brain Behav Immun Health) - "The present study aimed to evaluate and compare the blood-to-brain distribution of anakinra (IL-1 receptor antagonist), bermekimab (IL-1α antagonist) and canakinumab (IL-1β antagonist). As anakinra inhibits the actions of both IL-1α and IL-1β, it blocks all effects of IL-1 downstream signaling. The results herein further add to the growing body of evidence of the potential utility of anakinra to treat neuroinflammatory disorders."

Journal • Preclinical • Cardiovascular • CNS Disorders • Immunology • Inflammation • Vascular Neurology • CD34 • IL1B

[VIRTUAL] A phase I study of nanoliposomal irinotecan and 5-fluorouracil/folinic acid in combination with interleukin-1-alpha antagonist for advanced pancreatic cancer patients with cachexia (OnFX). (ASCO 2020) - P1 | "We report results of a single site phase 1 trial for an IL-1α antagonist (bermekimab) in combination with nanoliposomal irinotecan (Nal-Iri) and 5-fluorouracil (5FU)/folinic acid (FA) in patients with advanced pancreatic adenocarcinoma and cachexia who have failed gemcitabine-based chemotherapy. Bermekimab, nano-liposomal irinotecan and 5-fluorouracil in refractory pancreatic cancer patients with cachexia was well-tolerated with promising efficacy and improvements in patient performance. Research Funding: Ipsen"

Clinical • Combination therapy • P1 data • Anorexia • Cachexia • Fatigue • Gastrointestinal Cancer • Hematological Disorders • Immunology • Infectious Disease • Leukopenia • Neutropenia • Oncology • Pain • Pancreatic Adenocarcinoma • Pancreatic Cancer • Septic Shock • Solid Tumor • IL1A

A phase I study of nanoliposomal irinotecan and 5-fluorouracil/folinic acid in combination with interleukin-1-alpha antagonist for advanced pancreatic cancer patients with cachexia (OnFX). (ASCO-GI 2020) - P1; "The present study aims to establish the safety of an IL-1α antagonist (Bermekimab) in combination with nanoliposomal irinotecan (Nal-Iri) and 5-fluorouracil (5FU)/folinic acid (FA) in patients with advanced pancreatic adenocarcinoma and cachexia who have failed gemcitabine-based chemotherapy. Clinical trial information: NCT03207724. Research Funding: Ipsen and XBiotech, Inc"

Clinical • Combination therapy • P1 data • IL1A