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Method of treating neutrophilic conditions

A neutrophil and neutrophil technology, applied in the field of treatment of neutrophilic diseases, can solve the problems of patient discomfort, leukocyte apheresis, time-consuming and so on

Pending Publication Date: 2021-08-17
CSL INNOVATION PTY LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The disadvantage of GMA is that the patient must undergo leukapheresis once or twice in a hospital setting, five to ten times a week for about an hour each
Such treatments are time-consuming, uncomfortable for patients, and require specialized equipment and trained staff to administer

Method used

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  • Method of treating neutrophilic conditions
  • Method of treating neutrophilic conditions
  • Method of treating neutrophilic conditions

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0373] Example 1 - Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Administering G-CSFR-binding Antibody C1.2G to Healthy Adult Subjects

[0374] A Phase 1 clinical trial was conducted to evaluate the safety of single ascending doses (Parts A and B) and repeated (Part C) intravenous (IV) infusions of CSL324 (also referred to herein as C1.2G) in healthy subjects and tolerance.

[0375] method

[0376] This trial is the first single-center randomized double-blind placebo-controlled study in humans to evaluate the safety, tolerability, PK and pharmacodynamics (PD) of single ascending doses and repeated doses of IV CSL324 in healthy human subjects ). The study consisted of 3 parts: Parts A, B and C. Routine blinded review of safety, tolerability, PK and selected PD data was conducted by a Safety Review Committee (SRC) to guide dose selection. The trial is described in the Australia New Zealand Clinical Trials Register (ANZCTR), accession number ACTRN12616000846426...

Embodiment 2

[0468] Example 2 - Treatment of neutrophilic dermatosis with G-CSFR binding antibody CSL324

[0469] Research design

[0470] The safety and PK of repeated doses of intravenously administered CSL324 in subjects with HS and PPP were investigated using a multicentre, open-label, two-protocol repeat-dose study. This study also investigated the preliminary efficacy of CSL324 in subjects with HS and PPP.

[0471] The study included a 28-day screening period, a 15-week treatment period and a 9-week follow-up period. The study had 2 cohorts. Each cohort consisted of 20 subjects with HS (n=10) or PPP (n=10) ( image 3 ). CSL324 was initially administered to subjects participating in Cohort #1 as a 60-minute IV infusion of 0.3 mg / kg CSL324 at 21-day intervals on Days 1, 22, 43, 64, and 85. When the first 5 subjects in Cohort #1 administered CSL324 completed the 15-week treatment period, subjects in Cohort #2 were administered CSL324. The safest CSL324 dose (≥0.1 and ≤0.6 mg / kg)...

Embodiment 3

[0545] Example 3 - CSL324 reduces neutrophil migration associated with CXCR1 expression, a marker that is upregulated in HS patients.

[0546] CXCR1 expression in HS patients

[0547] Neutrophils on the surface of neutrophils were assessed by flow cytometry using whole blood samples from patients with hidradenitis suppurativa (HS; n=15) compared with neutrophils from whole blood samples from age- and sex-matched healthy controls. Levels of the cell migration marker CXCR1 (defined by high side scatter (SSC), CD11b+CD49-).

[0548] Such as Figure 7 As shown in A, CXCR1 expression was significantly higher in neutrophils from HS patient samples compared to healthy controls (n=15). A further analysis was observed showing the correlation between abscesses in HS patients and nodule counts, disease activity assessment forms, and CXCR1 expression on neutrophils in HS patients (n=14) ( Figure 7 B; r 2 = 0.3532, p = 0.0250).

[0549] CSL324 reduces G-CSF-induced expression of ...

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Abstract

The present disclosure relates to a method for reducing circulating neutrophils in a subject without causing sustained grade 3 or grade 4 neutropenia. The present disclosure also relates to methods for treating neutrophilic conditions with an antibody that inhibit G-CSF signalling. In particular, the present disclosure relates to methods of 5 treating neutrophilic dermatoses, such as hidradenitis suppurativa (HS) and palmoplantar pustulosis (PPP).

Description

[0001] relevant application data [0002] This application claims U.S. Patent Application No. 62 / 774,974, filed December 4, 2018, entitled "Methods of Treating Neutrophil Disorders," and filed August 12, 2019, entitled "Methods of Treating Neutrophil Disorders." Priority to U.S. Patent Application No. 62 / 885,373, filed September 9, 2019, and entitled "Methods of Treating Neutrophil Disorders." The entire contents of these applications are incorporated herein by reference. technical field [0003] The present invention relates to methods of treating neutrophil disorders using antibodies that bind granulocyte colony stimulating factor receptor (G-CSFR). Background technique [0004] Granulocyte colony stimulating factor (G-CSF) is the master regulator of granulocyte production. G-CSF is produced by bone marrow stromal cells, endothelial cells, macrophages and fibroblasts, and is induced by inflammatory stimuli. G-CSF acts through the G-CSF receptor (G-CSFR), which is expres...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07K16/28A61K39/395A61P17/06A61P17/10A61P37/06
CPCC07K16/2866A61P17/06A61P17/10A61P37/06A61K2039/505C07K2317/515C07K2317/565A61P17/00A61K2039/545C07K2317/90C07K2317/21C07K2317/76A61K39/395
Inventor K·L·因顾安蒂J·艾瑞J·西迪M·托特瑞茨T·尤拉斯扎克
Owner CSL INNOVATION PTY LTD
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