Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1802 |
| INN | Lirentelimab |
| Status | Terminated |
| Drug code(s) | AK002, Antolimab |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | Siglec-8 |
| Indications of clinical studies | Atopic Dermatitis, eosinophilic Esophagitis, Eosinophilic Gastritis, Chronic Urticaria, Systemic mastocytosis, Atopic Keratoconjunctivitis, Vernal Keratoconjunctivitis, and Perennial Allergic Conjunctivitis |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Terminated at Phase 3 |
| Status | Inactive |
| Start of clinical phase (IND filing or first Phase 1) | June 15, 2016 |
| Start of Phase 2 | January 23, 2018 |
| Start of Phase 3 | March 15, 2020 |
| 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 | Allakos Inc |
| Licensee/Partner | None |
| Comments about company or candidate | January 16, 2024: Allakos Announces Phase 2 Lirentelimab Trials in Atopic Dermatitis and Chronic Spontaneous Urticaria Did Not Meet Their Primary Endpoints. Allakos plans not to pursue further development of lirentelimab; will focus on AK006 clinical development and additional preclinical programs – Sep 2022: EoDyssey, a 24-week, Phase 3, randomized, double-blind, placebo-controlled study of lirentelimab in patients with biopsy confirmed eosinophilic duodenitis (EoD) met its histologic co-primary endpoint, but it did not achieve statistical significance on the patient reported symptomatic co-primary endpoint, in both the intent to treat (ITT) population and in a prespecified subpopulation. Allakos is not planning to conduct additional studies in eosinophilic gastrointestinal diseases, but may do so in the future. Allakos is focusing development efforts for lirentelimab in atopic dermatitis and chronic spontaneous urticaria and on AK006. Allakos is conducting a Phase 2 randomized, double-blind, placebo-controlled study of subcutaneous lirentelimab in patients with moderate-to-severe atopic dermatitis and a Phase 2b randomized, double-blind, placebo-controlled study of subcutaneous lirentelimab in patients with chronic spontaneous urticaria. The Company anticipates reporting topline data from these studies in the second half of 2023. July 2022 company presentation: Topline data in EoD expected Q3 2022, but no mention of submission plans NCT04620811 Phase 3 in Eosinophilic Duodenitis Oct 2020: Results of Phase 2 study of lirentelimab (AK002) in patients with eosinophilic gastritis and/or eosinophilic duodenitis (ENIGMA) published in the New England Journal of Medicine. Aug 2020: The nonproprietary (generic) name of AK002 was changed from antolimab to lirentelimab as a result of trademark issues identified outside of the United States. Lirentelimab has been adopted by the United States Adopted Names (USAN) Council and World Health Organization (WHO) International Nonproprietary Names (INN) Program. NCT04322604 Phase 3 and NCT04322708 Phase 2/3 study started in March 2020. February 11, 2019 I Allakos Inc., a biotechnology company developing AK002 for the treatment of eosinophil and mast cell related diseases, today announced positive Phase 2 results for AK002 in patients with Xolair refractory chronic spontaneous urticaria (CSU). The Xolair failure cohort enrolled 11 patients who failed to have an adequate response to prior Xolair treatment. Patients in this cohort had received an average of 10 months of Xolair treatment at doses as high as 600 mg per month. The primary efficacy endpoint was change from baseline in Urticaria Control Test (UCT) assessed at week 22, two weeks after the last dose of AK002. NCT03496571 Phase 2 study in EG recruiting as of July 2018. NCT02859701 Phase 1 initial dosing announced Sep 15, 2016. US orphan drug designation for EG and EGE |
| Full address of company | 825 Industrial Road, Suite 500, San Carlos, CA 94070 North America United States of America https://www.allakos.com/contact/ |
AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8, a member of the CD33-related family of sialic acid-binding, immunoglobulin-like lectins (Siglecs). AK002 selectively depletes mast cells and eosinophils. Binding of AK002 to specific receptors present on mast cells and eosinophils results in removal of these cells by a natural defense mechanism within the body called antibody-dependent cell-mediated cytotoxity.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | Lack of efficacy |