Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 295 |
| INN | Imsidolimab |
| Status | Clinical |
| Drug code(s) | ANB019 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG4 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Generated using AnaptysBio's proprietary somatic hypermutation-based antibody platform, known as SHM-XEL |
| Target(s) | IL-36R |
| Indications of clinical studies | Ichthyosis, EGFRi/MEKi-associated acneiform rash, Generalized pustular psoriasis, Phase 1 in healthy volunteers |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | April 01, 2017 |
| Start of Phase 2 | June 15, 2018 |
| Start of Phase 3 | November 01, 2021 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | AnaptysBio Inc. |
| Licensee/Partner | None |
| Comments about company or candidate | Company Intends to out-license imsidolimab in 2024 (https://ir.anaptysbio.com/news-releases/news-release-details/anaptys-announces-first-quarter-2024-financial-results-and) Oct 2023: GEMINI-1 Met Primary Endpoint Achieving Rapid Clearance of GPP Through Week 4 After a Single Dose; company plans BLA in Q3 2024 and to out-license imsidolimab in 2024 NCT05366855 Phase 3 study is GEMINI2; anticipate top-line data from the GEMINI-1 Phase 3 clinical trial in Q4 2023. Aug 2022: AnaptysBio, Inc. announced top-line data from its HARP Phase 2 trial for the treatment of moderate-to-severe hidradenitis suppurativa (HS). The trial indicated imsidolimab was safe and well tolerated, however did not demonstrate efficacy over placebo in the trial’s primary endpoint and key secondary endpoints. Clinical development of imsidolimab is being discontinued in hidradenitis suppurativa. The company plans to outlicense investigational imsidolimab prior to potential FDA approval for the treatment of GPP. Company website accessed April 28, 2022: We held an end-of-Phase 2 meeting with the FDA during Q2 2021 to review an orphan disease development plan for imsidolimab for the treatment of GPP and initiated our first Phase 3 trial, called GEMINI-1, in Q3 2021. GEMINI-1 will enroll approximately 45 moderate-to-severe GPP patients, each undergoing an active flare at baseline, which will be randomized equally to receive a single dose of 750mg intravenous (IV) imsidolimab, 300mg IV imsidolimab or placebo. The primary endpoint of the Phase 3 program is the proportion of patients achieving clear or almost clear skin as determined by a Generalized Pustular Psoriasis Physician’s Global Assessment (GPPPGA) score of zero or 1 at week 4 of GEMINI-1. Patients will subsequently be re-enrolled in GEMINI-2, where they will receive monthly doses of 200mg subcutaneous imsidolimab or placebo depending upon whether they are responders, partial responders or non-responders to treatment under GEMINI-1. The objective of GEMINI-2 is to assess the efficacy and safety of imsidolimab after 6 months of monthly dosing. March 08, 2021: AnaptysBio, Inc. announced that top-line data from its Phase 2 clinical trial of imsidolimab for the treatment of moderate-to-severe palmoplantar pustulosis (PPP), also known as the POPLAR trial, failed to meet its primary endpoint. NCT04697069 Phase 2 study in in the Treatment of Acneiform Rash in Subjects With Cancer Receiving EGFRi or MEKi Therapy and NCT04697056 Phase 2 study in Ichthyosis due to start in Jan 2021. July 8, 2020: AnaptysBio announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for imsidolimab, the company’s proprietary anti-interleukin-36 receptor (IL-36R) antibody, for the treatment of patients with Generalized Pustular Psoriasis (GPP). The company reported that additional data and regulatory strategy update from generalized pustular psoriasis (GPP) Phase II GALLOP trial is anticipated during H2 2020. Palmoplantar pustulosis (PPP) Phase II POPLAR trial top-line data anticipated in 2021. Company anticipates initiating a Phase II trial of imsidolimab for Ichthyosis during the fourth quarter of 2020. Company anticipates initiating a Phase II trial of imsidolimab, in combination with EGFRi/MEKi inhibitors, to assess its efficacy in the treatment of skin toxicity in Q4 2020. NCT03633396 Phase 2 study started in May 2019 still recruiting in Aug 2019. Phase 2 POPLAR study of ANB019 in palmoplantar pustulosis was initiated in the second half of 2018. AnaptysBio has initiated a 10-patient open-label Phase 2 trial of ANB019 in GPP, also known as the GALLOP trial and top-line data are anticipated by early 2019. Patients are dosed with a 750mg intravenous loading dose of ANB019 upon enrollment, followed by 100mg subcutaneously-administered monthly doses of ANB019 for a treatment period of up to 16 weeks post enrollment and followed an eight-week follow-up period. The company plans to initiate a placebo-controlled 50-patient multi-dose Phase 2 trial in PPP, also known as the POPLAR trial, where top line data is anticipated in the second half of 2019.Data from Phase 1 trial presented at the 2018 European Academy of Allergy and Clinical Immunology (EAACI) Congress on May 28th 2018; Phase 2 study started after this. Company plans to initiate a separate Phase 2 trial in palmoplantar pustulosis during 2018. April 2017: AnaptysBio initiated a Phase 1 clinical trial in healthy volunteers in Australia in which ANB019 will be administered in single and multiple doses through subcutaneous and intravenous routes of administration, with top-line results expected during the second half of 2017. Phase 2 studies for the treatment of two orphan inflammatory diseases, generalized pustular psoriasis and palmo-plantar pustular psoriasis, are anticipated to begin during 2018. The Company’s anti-IL-36R therapeutic antibody, called ANB019, is a novel treatment for generalized pustular psoriasis (GPP), an orphan systemic inflammatory disease with high unmet medical need. ANB019 is wholly owned within AnaptysBio’s proprietary antibody pipeline. ANB019 is a potent functional antagonist of IL-36R signaling generated using AnaptysBio's proprietary somatic hypermutation-based antibody platform, known as SHM-XEL |
| Full address of company | 10770 Wateridge Circle, Suite 210, San Diego, CA 92121-5801 North America United States of America https://www.anaptysbio.com/contact/ |
ANB019 is a specific high affinity anti-human IL-36R antibody, generated using AnaptysBio’s proprietary antibody discovery platform. In preclinical studies, ANB019 exhibited potent IL36 inhibitory activity, as demonstrated by inhibition of IL-8 release by primary human keratinocytes stimulated with IL-36γ (similar results were obtained using IL-36 alpha and β). ANB019 inhibition of IL-36R was 100-fold more potent than IL-36RA, the physiological antagonist of IL-36 signaling.
| Anticipated events | Company plans to out-license in 2024 |
| Factor(s) contributing to discontinuation | None |