imsidolimab (ANB019) / AnaptysBio, Vanda - LARVOL DELTA

Imsidolimab, a novel IgG4 IL36 receptor antagonist, was effective and well tolerated in patients with GPP (SID 2025) - "In contrast, a total of 23 cases of ADAs (23/50, 46%) were reported among patients who had received at least 1 dose of spesolimab. Imsidolimab has demonstrated effectiveness in GPP with a well tolerated and safe profile after a single dose. Targeting IL36 signaling with imsidolimab represents a promising therapeutic option."

Clinical • Late-breaking abstract • Dermatology • Immunology • Pain • Psoriasis • Pustular Psoriasis

Vanda Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Financial Results (PRNewswire) - "PONVORY (ponesimod): Investigational New Drug (IND) applications for PONVORY in the treatments of psoriasis and ulcerative colitis were accepted by the FDA in the fourth quarter of 2024....Imsidolimab BLA in generalized pustular psoriasis expected to be submitted in 2025.....Imsidolimab: Vanda expects to initiate and complete the technology transfer activities in 2025 and immediately begin preparing the Biologics License Application (BLA) and MAA for generalized pustular psoriasis (GPP) for the US and EU. The imsidolimab BLA for GPP is expected to be submitted to the FDA in 2025."

EMA filing • FDA filing • IND • Immunology • Psoriasis • Ulcerative Colitis

Vanda Pharmaceuticals and Anaptys Announce Exclusive Global License Agreement for Vanda to Develop and Commercialize Imsidolimab, an IL-36R Antagonist (PRNewswire) - "Vanda Pharmaceuticals Inc...today announced an exclusive, global license agreement for the development and commercialization of imsidolimab (IL-36R antagonist mAb)...In 2025, Vanda intends to initiate and complete the technology transfer activities and will immediately begin preparing the BLA and MAA applications for the US and EU and making preparations for commercialization...Under the terms of the agreement, Vanda will make to Anaptys an upfront payment of $10 million and a $5 million payment for existing drug supply. Anaptys is also eligible to receive up to $35 million for future regulatory approval and sales milestones in addition to a 10% royalty on net sales. Vanda will receive an exclusive global license to develop, manufacture and commercialize imsidolimab."

Licensing / partnership • Psoriasis

Imsidolimab, an IL-36 Receptor Antagonist, was Effective and Well Tolerated for Treatment and Prevention of Flares in Patients with Generalized Pustular Psoriasis: Results from the Phase 3 Trials, GEMINI-1 and GEMINI-2 (EADV 2024) - P3 | "Single IV doses of imsidolimab 300mg and 750mg demonstrated clinically meaningful results and were well tolerated in patients with GPP flares. Maintenance dosing with monthly SC imsidolimab for at least 24 wks was also well tolerated, maintained GPPPGA 0/1 responses and prevented GPP flares. Targeting IL-36 signaling with imisdolimab represents a promising therapeutic option for GPP patients."

Clinical • P3 data • Complement-mediated Rare Disorders • Dermatology • Eosinophilia • Immunology • Infectious Disease • Psoriasis • Pustular Psoriasis

Imsidolimab, an IL-36 receptor antagonist, was effective and well tolerated for treatment and prevention of flares in patients with generalized pustular psoriasis: results from the phase 3 trials, GEMINI-1 and GEMINI-2 (EADV 2024) - P3 | "Single IV doses of imsidolimab 300mg and 750mg demonstrated clinically meaningful results and were well tolerated in patients with GPP flares. Maintenance dosing with monthly SC imsidolimab for at least 24 wks was also well tolerated, maintained GPPPGA 0/1 responses and prevented GPP flares. Targeting IL-36 signaling with imisdolimab represents a promising therapeutic option for GPP patients."

Clinical • P3 data • Complement-mediated Rare Disorders • Dermatology • Eosinophilia • Immunology • Infectious Disease • Psoriasis • Pustular Psoriasis

GEMINI2: Long-Term Safety and Efficacy of Imsidolimab (ANB019) in Subjects With Generalized Pustular Psoriasis (clinicaltrials.gov) - P3 | N=42 | Terminated | Sponsor: AnaptysBio, Inc. | Trial completion date: Dec 2026 ➔ Jul 2024 | Active, not recruiting ➔ Terminated | Trial primary completion date: Jun 2024 ➔ Feb 2024; AnaptysBio has concluded the GEMINI-2 trial, with all trial participants having been treated with imsidolimab for approximately six months and the furthest patient having been treated through 92 weeks

Trial completion date • Trial primary completion date • Trial termination • Dermatology • Immunology • Psoriasis • Pustular Psoriasis

Anaptys Announces Second Quarter 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Updates on Wholly Owned ICM Pipeline:...Legacy Clinical-Stage Cytokine Antagonist Programs Available for Out-Licensing: (i) Comprehensive data from the Phase 3 GEMINI-1 and GEMINI-2 trials to be presented at a medical meeting in H2 2024; (ii) Intend to out-license imsidolimab in 2024."

Licensing / partnership • P3 data: top line • Psoriasis

New and Emerging Treatments for Generalized Pustular Psoriasis: Focus on IL-36 Receptor Inhibitors. (PubMed, Pharmaceutics) - "Until recently, no specific treatment modalities were available, and treatment for GPP followed the guidelines for the treatment of plaque psoriasis, consisting of conventional treatments, such as retinoids, methotrexate, and even biologics, which although effective in some cases, may be associated with significant side effects, necessitating more effective and safe options...Spesolimab and imsidolimab, two recently developed therapeutic agents, target the IL-36 inflammatory pathway by binding to the IL-36 receptor (IL-36R)...IL-36 receptor inhibitors demonstrated great efficacy and good safety profile in the management of patients with GPP, demonstrating their potential to emerge as a leading treatment option. This review aims to explore and summarize the current scientific literature on the most recently developed treatments for GPP."

Journal • Review • Dermatology • Immunology • Psoriasis • Pustular Psoriasis

Small-Molecule Inhibitors and Biologics for Palmoplantar Psoriasis and Palmoplantar Pustulosis: A Systematic Review and Network Meta-Analysis. (PubMed, Am J Clin Dermatol) - "Among all available biologics and small-molecule inhibitors, secukinumab 300 mg and guselkumab 100 mg had the most favorable efficacy in treating PP and PPP, respectively."

Journal • Retrospective data • Review • Dermatology • Immunology • Psoriasis

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

The Expanding Horizon of anti-IL-36 Therapy. (PubMed, J Am Acad Dermatol) - No abstract available

Journal • Dermatology • Immunology • Psoriasis • Pustular Psoriasis

Generalized Pustular Psoriasis: A Consensus Statement from the National Psoriasis Foundation. (PubMed, J Am Acad Dermatol) - No abstract available

Journal • Dermatology • Immunology • Psoriasis • Pustular Psoriasis

ANAPTYS ANNOUNCES POSITIVE TOP-LINE PHASE 3 CLINICAL TRIAL RESULTS OF IMSIDOLIMAB (IL-36R) IN GENERALIZED PUSTULAR PSORIASIS (GPP) (AnaptysBio Press Release) - P3 | N=45 | GEMINI1 (NCT05352893) | Sponsor: AnaptysBio, Inc. | "Intend to out-license imsidolimab in 2024...AnaptysBio, Inc...today announced positive top-line results from its global Phase 3 GEMINI-1 trial....Investigational imsidolimab met its primary endpoint in the study population achieving rapid clearance of pustulation, erythema and scaling through Week 4 after a single dose of 750mg IV imsidolimab. Top-line data also demonstrate a favorable safety and tolerability profile....53.3% of patients who received a single dose of 750mg IV imsidolimab achieved GPPPGA 0/1 (clear or almost clear) at Week 4 (primary endpoint), compared to 13.3% of patients on placebo (p=0.0131)....Anaptys plans to present comprehensive data from GEMINI-1 and top-line GEMINI-2 results at a medical meeting in H2 2024. Furthermore, the company anticipates filing a biologics license application (BLA) with the U.S. Food and Drug Administration (FDA) by Q3 2024."

BLA • Licensing / partnership • P3 data • P3 data: top line • Immunology • Psoriasis

GEMINI2: Long-Term Safety and Efficacy of Imsidolimab (ANB019) in Subjects With Generalized Pustular Psoriasis (clinicaltrials.gov) - P3 | N=42 | Active, not recruiting | Sponsor: AnaptysBio, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Dermatology • Immunology • Psoriasis • Pustular Psoriasis

GEMINI1: Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With GPP (clinicaltrials.gov) - P3 | N=45 | Completed | Sponsor: AnaptysBio, Inc. | Recruiting ➔ Completed | Trial completion date: Dec 2023 ➔ Aug 2023 | Trial primary completion date: Dec 2023 ➔ Aug 2023

Trial completion • Trial completion date • Trial primary completion date • Dermatology • Immunology • Psoriasis • Pustular Psoriasis

Anti-IL-36 receptor treatment with imsidolimab shows promise for generalized pustular psoriasis, with 6 of 8 patients meeting the primary endpoint of this open label study in this month's @BrJDermatol :

Imsidolimab for the treatment of generalized pustular psoriasis. (PubMed, Br J Dermatol) - No abstract available

Journal • Dermatology • Immunology • Psoriasis • Pustular Psoriasis

Imsidolimab showed ‘rapid and sustained’ activity in generalized pustular psoriasis (Healio) - "'Generalized pustular psoriasis (GPP) is a systemic inflammatory disease that can be severe, debilitating, and life-threatening,' Richard B. Warren..."

Media quote • Pustular Psoriasis

Imsidolimab: an emerging biologic therapy for generalised pustular psoriasis. (PubMed, Br J Dermatol) - No abstract available

Journal • Dermatology • Immunology • Psoriasis • Pustular Psoriasis

Comparative efficacy of biologics and oral agents in palmoplantar psoriasis and palmoplantar pustulosis: A systematic review and network meta-analysis of randomized clinical trials. (PubMed, J Am Acad Dermatol) - No abstract available

Clinical • Journal • Retrospective data • Review • Dermatology • Immunology • Psoriasis

AnaptysBio Announces British Journal of Dermatology Publication of Imsidolimab (IL-36R) Previously Reported Phase 2 GALLOP Data in Generalized Pustular Psoriasis (GPP) (PRNewswire) - "AnaptysBio, Inc...announced the publication of data from the open-label, single-arm Phase 2 GALLOP study evaluating the efficacy, tolerability and safety of imsidolimab...'We look forward to sharing the top-line data on the efficacy, safety and tolerability of a single dose IV infusion of imsidolimab in moderate-to-severe GPP patients from the ongoing GEMINI-1 Phase 3 trial in Q4 2023, whereafter we plan to out license the program prior to a potential FDA approval'...Clinical responses were observed as early as Day 3, most rapidly for pustulation relative to other visible manifestations of GPP, with continued and consistent improvement across multiple efficacy assessments at Day 8, Day 29, and through Day 113. Of the six patients evaluable on Day 29, all achieved the primary endpoint of clinical response on the clinical global impression scale (CGI). "

P2 data • P3 data: top line • Dermatology • Immunology • Inflammation • Psoriasis • Pustular Psoriasis

Imsidolimab, an Anti-IL-36 Receptor Monoclonal Antibody for the Treatment of Generalised Pustular Psoriasis: Results from the Phase 2 GALLOP Trial. (PubMed, Br J Dermatol) - P2 | "Imsidolimab demonstrated a rapid and sustained resolution of symptoms and pustular eruptions in subjects with GPP. It was generally well-tolerated, associated with acceptable safety, and is advancing to Phase 3 trials. These data support targeting of IL-36 signalling with a specific antibody, imsidolimab, as a therapeutic option for this severely debilitating condition. The study was registered under EudraCT Number 2017-004021-33 and NCT03619902."

Journal • P2 data • Dermatology • Immunology • Inflammation • Psoriasis • Pustular Psoriasis

IMG-008, a potent anti-human IL-36R antagonistic antibody, inhibits IL-36R-mediated inflammation (ISID 2023) - "The inhibition activity was comparable to spesolimab analog and superior to imsidolimab analog. Administration of IMG-008 suppressed imiquimod induced skin inflammation in hIL-36R mice, which was superior to spesolimab analog... IMG-008 exhibited potent IL-36R blocking activity from in vitro assays and in vivo skin inflammation animal model. In addition, IMG-008 has improved drug exposure and extended half-life. In conclusion, our preclinical results support IMG-008 as a promising candidate for treating IL-36R mediated inflammatory disease."

Dermatitis • Dermatology • Gastroenterology • Gastrointestinal Disorder • Hidradenitis Suppurativa • Immunology • Inflammation • Inflammatory Bowel Disease • Psoriasis

Targeting IL-36 in Inflammatory Skin Diseases. (PubMed, BioDrugs) - "In this context, the clinical efficacy and safety profiles of anti-IL-36 agents such as spesolimab and imsidolimab have been evaluated in patients with generalized pustular psoriasis, palmoplantar pustulosis, hidradenitis suppurativa, acne/acneiform eruptions, ichthyoses, and atopic dermatitis. This article comprehensively summarizes the roles played by IL-36 cytokines in the pathogenesis and pathophysiology of various skin diseases and summarizes the current state of research on therapeutic agents that target IL-36 cytokine pathways."

Journal • Acne Vulgaris • Atopic Dermatitis • Dermatitis • Dermatology • Hidradenitis Suppurativa • Immunology • Infectious Disease • Inflammation • Psoriasis • Pustular Psoriasis • Vitiligo • CD123

A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With Hidradenitis Suppurativa (clinicaltrials.gov) - P2 | N=149 | Completed | Sponsor: AnaptysBio, Inc. | Active, not recruiting ➔ Completed

Trial completion • Dermatology • Hidradenitis Suppurativa