[Translation] A Phase II clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy of multiple doses of BA2101 in patients with moderate to severe atopic dermatitis

1. 主要目的：在中重度特应性皮炎患者中评价BA2101 多次给药的安全性、耐受性。 2. 次要目的：在中重度特应性皮炎患者中评价BA2101 多次给药的药代动力学（PK）、药效学（PD）、免疫原性及初步疗效。

[Translation]

1. Primary objective: To evaluate the safety and tolerability of multiple administrations of BA2101 in patients with moderate to severe atopic dermatitis. 2. Secondary objective: To evaluate the pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity and preliminary efficacy of multiple administrations of BA2101 in patients with moderate to severe atopic dermatitis.

Start Date-

Sponsor / Collaborator

Shandong Boan Biotechnology Co., Ltd.

CTR20230119 / CompletedPhase 1

在健康受试者中评价BA2101单次皮下注射的安全性、耐受性、药代动力学、药效学及免疫原性的随机、双盲、安慰剂对照、剂量递增的Ⅰ期临床研究

[Translation] A randomized, double-blind, placebo-controlled, dose-escalating Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of a single subcutaneous injection of BA2101 in healthy subjects

主要目的：在健康受试者中评价BA2101单次皮下注射的安全性和耐受性。次要目的：在健康受试者中评价BA2101单次皮下注射的PK、PD及免疫原性。

[Translation]

Primary objective: To evaluate the safety and tolerability of a single subcutaneous injection of BA2101 in healthy subjects. Secondary objective: To evaluate the PK, PD and immunogenicity of a single subcutaneous injection of BA2101 in healthy subjects.

Start Date09 Feb 2023

Sponsor / Collaborator

Shandong Boan Biotechnology Co., Ltd.

ChiCTR2300068047 / SuspendedPhase 1IIT

A randomized, double-blind, placebo-controlled, dose-escalation phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of BA2101 as a single subcutaneous injection in healthy subjects

Start Date03 Feb 2023

Sponsor / Collaborator

Xiangya Hospital Central South University

100 Clinical Results associated with BA-2101

100 Translational Medicine associated with BA-2101

100 Patents (Medical) associated with BA-2101

Literatures (Medical) associated with BA-2101

01 Jul 2024·The Journal of Allergy and Clinical Immunology: In Practice

Long-Term Effectiveness of Anti-IL-4R Therapy Following Suboptimal Response to Anti-IL-5/5R Therapy in Severe Eosinophilic Asthma

Article

Author: Hearn, Andrew ; d'Ancona, Grainne ; Lam, Jodie ; Fernandes, Mariana ; Nanzer, Alexandra M ; Roxas, Cris ; Dhariwal, Jaideep ; Thomson, Louise ; Gates, Jessica ; Jackson, David J ; Mason, Tom ; Green, Linda

BACKGROUNDDupilumab is an anti-IL-4R monoclonal antibody (mAb) with proven efficacy in severe eosinophilic asthma (SEA). A suboptimal response to anti-IL-5/5R mAbs is seen in some patients with ongoing evidence of type 2 (T2) inflammation.OBJECTIVETo understand whether targeting IL-13 pathways with dupilumab in these patients may lead to better clinical outcomes.METHODSWe performed a retrospective analysis of the extended clinical effectiveness of dupilumab up to 2 years of treatment in patients with SEA who had not responded adequately to anti-IL-5/5R biologics. The ability to achieve clinical remission and the change in the remission domains of exacerbation rate (AER), maintenance oral corticosteroid dose (mOCS), lung function (forced expiratory volume in 1 second), and asthma control (Asthma Control Questionnaire 6) were recorded.RESULTSThirty-seven patients (mean age 41 years, 70% female) were included in the analysis. The mean (standard deviation) AER fell by almost 90% from 3.16 (1.28) at dupilumab initiation to 0.35 (0.72) after 1 year. The median (interquartile range) mOCS dose (n = 20) fell from 10 (5-25) mg to 0 (0-5) mg at 1 year, with 14 of 20 (70%) able to stop prednisolone altogether. Clinical remission was achieved in 16 of 37 (43%). Patients who achieved remission had a higher pre-IL-5/5R fractional exhaled nitric oxide (FeNO) level (85 [39-198] parts per billion [ppb] vs 75 [42-96] ppb, P = .03).CONCLUSIONSSignificant improvements in clinical outcomes are possible after a switch to dupilumab in patients experiencing a suboptimal response to anti-IL-5/5R therapies. A higher FeNO in poor responders to anti-IL-5/5R who achieve remission with dupilumab is suggestive of an IL-13-driven subphenotype of T2-high asthma in which the eosinophil appears unlikely to play a key role in the disease pathogenesis.

Nature Communications

Dupilumab-associated head and neck dermatitis shows a pronounced type 22 immune signature mediated by oligoclonally expanded T cells

Article

Author: Arnoldner, Tamara ; Jonak, Constanze ; Brunner, Patrick M ; Medjimorec, Marco A ; Chennareddy, Sumanth ; Griss, Johannes ; Damsky, William ; Pilz, Magdalena ; Ruggiero, John ; Bangert, Christine ; Alkon, Natalia ; Levine, Jasmine P ; Cohenour, Emry R

AbstractDupilumab, an IL4R-blocking antibody, has shown clinical efficacy for atopic dermatitis (AD) treatment. In addition to conjunctivitis/blepharitis, the de novo appearance of head/neck dermatitis is now recognized as a distinct side effect, occurring in up to 10% of patients. Histopathological features distinct from AD suggest a drug effect, but exact underlying mechanisms remain unknown. We profiled punch biopsies from dupilumab-associated head and neck dermatitis (DAHND) by using single-cell RNA sequencing and compared data with untreated AD and healthy control skin. We show that dupilumab treatment was accompanied by normalization of IL-4/IL-13 downstream activity markers such as CCL13, CCL17, CCL18 and CCL26. By contrast, we found strong increases in type 22-associated markers (IL22, AHR) especially in oligoclonally expanded T cells, accompanied by enhanced keratinocyte activation and IL-22 receptor upregulation. Taken together, we demonstrate that dupilumab effectively dampens conventional type 2 inflammation in DAHND lesions, with concomitant hyperactivation of IL22-associated responses.

100 Deals associated with BA-2101

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Moderate Atopic Dermatitis	Phase 2	CN	Shandong Boan Biotechnology Co., Ltd.	19 Jul 2024
Severe Atopic Dermatitis	Phase 2	CN	Shandong Boan Biotechnology Co., Ltd.	19 Jul 2024
Asthma	Phase 2	CN	Shandong Boan Biotechnology Co., Ltd.	-
Pruritus	Phase 2	CN	Shandong Boan Biotechnology Co., Ltd.	-
Pulmonary Disease, Chronic Obstructive	Phase 2	CN	Shandong Boan Biotechnology Co., Ltd.	-
Sinusitis	Phase 2	CN	Shandong Boan Biotechnology Co., Ltd.	-
Urticaria	Phase 2	CN	Shandong Boan Biotechnology Co., Ltd.	-
Chronic Urticaria	Phase 1	CN	Shandong Boan Biotechnology Co., Ltd.	09 Feb 2023
prurigo nodularis	Phase 1	CN	Shandong Boan Biotechnology Co., Ltd.	09 Feb 2023
Chronic rhinosinusitis with nasal polyps	IND Approval	CN	Shandong Boan Biotechnology Co., Ltd.	22 Nov 2022

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