A Randomized, Double-Blind, Placebo/Active Controlled, Single Dose, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Subcutaneous Injections of YH35324 in Patients with Various Allergic Diseases

This study aims to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) following a single subcutaneous injection of YH35324 in subjects with various allergic diseases.

Start Date23 Aug 2023

Sponsor / Collaborator

Yuhan Corp.

NCT05564221 / Active, not recruitingPhase 1

A Randomized, Double-Blind, Placebo/Active Controlled, Multiple Ascending Dose, Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Subcutaneous Injections of YH35324 in Atopic Healthy Subjects or Subjects With Allergic Diseases

This study aims to evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) profiles following multiple subcutaneous injections of YH35324 in healthy subjects or subjects with allergic diseases, who have atopy.

Start Date01 Nov 2022

Sponsor / Collaborator

Yuhan Corp.

NCT05061524 / CompletedPhase 1

A First-in-Human, Randomized, Double-Blind, Placebo/Active Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Following Subcutaneous Injections of YH35324 in Atopic Healthy Subjects or Subjects with Mild Allergic Diseases

The purpose of this study is to evaluate the safety, tolerability, PK, and PD following subcutaneous injections of YH35324 in atopic healthy subjects or adult subjects with mild allergic diseases. Eligible subjects will be randomized to the YH35324 group, the placebo group, or the omalizumab group.

Start Date26 Sep 2021

Sponsor / Collaborator

Yuhan Corp.

100 Clinical Results associated with Lesigercept

100 Translational Medicine associated with Lesigercept

100 Patents (Medical) associated with Lesigercept

Literatures (Medical) associated with Lesigercept

01 Mar 2024·International immunopharmacology

Safety, Tolerability, Pharmacokinetics, and pharmacodynamics of YH35324, a novel Long-Acting High-Affinity IgETrap-Fc protein in subjects with Atopy: Results from the First-in-Human study

Article

Author: Lee, Sae Young ; Ye, Young-Min ; Cho, You Sook ; Kim, Sae-Hoon ; Jang, Myoung Ho ; Park, Jung-Won ; Song, Eunji ; Lee, Jieon ; Kim, Su Kyung ; Kim, Bomin ; Sim, Sujin ; Park, Hae-Sim ; Lee, Sook Young

BACKGROUND:

YH35324, a long-acting IgETrap-Fc fusion protein, is a novel therapeutic agent for immunoglobulin E (IgE)-mediated allergic diseases. This randomized, double-blind, placebo/active-controlled, single ascending dose Phase 1 study assessed the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of YH35324 in subjects with atopy.

METHODS:

Eligible subjects were healthy subjects or atopic adults with mild allergic rhinitis, atopic dermatitis, food allergy, or urticaria, and a serum total IgE level of 30-700 IU/mL (Part A) or > 700 IU/mL (Part B). In Part A, 35 subjects in 5 cohorts received YH35324 (0.3, 1, 3, 6, and 9 mg/kg), 8 received omalizumab (300 mg), and 9 received placebo. In Part B, 8 subjects received YH35324 and 8 received omalizumab.

RESULTS:

Twenty subjects (38.5 %) in Part A (YH35324: 37.1 %, omalizumab: 50.0 %, placebo: 33.3 %) and 10 subjects (62.5 %) in Part B (YH35324: 100 %; omalizumab: 25.0 %) experienced treatment-emergent adverse events (TEAEs). TEAEs were mostly grade 1/2; no serious AEs, AE-related treatment discontinuation, or anaphylaxis were reported. YH35324 exhibited dose-proportional increase in C_max and AUC_last over the dose range of 0.3-9 mg/kg. YH35324 rapidly suppressed serum-free IgE levels to a significant extent (< 25 and < 82.8 ng/mL, both P < 0.05) and with longer duration than omalizumab.

CONCLUSION:

This study showed that YH35324 has a favorable safety profile and is effective in reducing serum-free IgE levels in subjects with atopic conditions.

PloS one

Detection of serum IgG autoantibodies to FcεRIα by ELISA in patients with chronic spontaneous urticaria

Article

Author: Ye, Young-Min ; Lee, Youngsoo ; Jang, Jae-Hyuk ; Ryu, Min Sook ; Yang, Eun-Mi ; Moon, Jiyoung ; Park, Hae-Sim

Background:

Mast cells are a key effector cell in the pathogenesis of chronic spontaneous urticaria (CSU) and activated by circulating FcεRI-specific IgG as well as IgE. This study evaluated the prevalence of circulating autoantibodies to FcεRIα in the sera of CSU patients.

Methods:

Eighty-eight patients with CSU and 76 healthy controls (HCs) were enrolled. To detect circulating autoantibodies (IgG/IgA/IgM) to FcεRIα, ELISA was done using YH35324 (as a solid phase antigen), and its binding specificity was confirmed by the ELISA inhibition test. The antibody levels were presented by the ratio of YH35324-preincubated to mock-preincubated absorbance values. Clinical and autoimmune parameters, including atopy, urticaria activity score (UAS), serum total/free IgE levels, serum antinuclear antibody (ANA) and autologous serum skin test (ASST) results, were assessed. The autoimmune group was defined if CSU patients had positive results to ASST and/or ANA.

Results:

The ratio of serum IgG to FcεRIα was significantly lower in CSU patients than in HCs (P<0.05), while no differences were noted in serum levels of IgG to recombinant FcεRIα or IgA/IgM autoantibodies. The autoimmune CSU group had significantly lower ratios of IgG/IgA (not IgM) autoantibodies to FcεRIα than the nonautoimmune CSU group (P<0.05 for each). No significant associations were found between sex, age, atopy, urticaria duration, UAS, or serum total/free IgE levels according to the presence of IgG/IgA/IgM antibodies.

Conclusions:

This study confirmed the presence of IgG to FcεRIα in the sera of CSU patients, especially those with the autoimmune phenotype.

News (Medical) associated with Lesigercept

09 Jun 2021

·www.globenewswire.com

A Comprehensive Analysis of 18+ Key Companies Strengthening Chronic Spontaneous Urticaria Pipeline | Insights by DelveInsight

Los Angeles, June 08, 2021 (GLOBE NEWSWIRE) -- A Comprehensive Analysis of 18+ Key Companies Strengthening Chronic Spontaneous Urticaria Pipeline | Insights by DelveInsight For the treatment of Chronic Spontaneous Urticaria, there are several drugs being developed by different pharmaceutical industries with different routes of administration like oral, subcutaneous, intravenous which could be chosen according to the affordability and feasibility of an individual. DelveInsight’s ‘Chronic Spontaneous Urticaria Pipeline Insights’ report offers a holistic coverage of the current treatments and pipeline therapies and landscape in different stages of development from pre-clinical till late-stage, along with dormant, inactive and abandoned therapeutic agents. Some of the key pointers from the Chronic Spontaneous Urticaria Pipeline report: Request for Sample to know more about the key pharma company and therapy expected to grab maximum share @ Chronic Spontaneous Urticaria Emerging Therapies and Forecast Chronic Spontaneous Urticaria: Overview Chronic Urticaria (CU) is a condition of the skin caused by a plenitude of factors such as environmental irritants, your immune system, genetics, or in response to a bacterial, fungal, or viral infection. Based on the cause, it can be of two types Chronic Idiopathic Urticaria (also called chronic spontaneous urticaria) and Chronic Inducible Urticaria (also called physical urticaria). Chronic Spontaneous Urticaria was previously referred to as Chronic Idiopathic Urticaria, however, the term is no longer used as many cases have an autoimmune basis. For more information on emerging drugs, visit Chronic Spontaneous Urticaria Pipeline Analysis Chronic Spontaneous Urticaria Drug Pipeline Assessment Request for Sample to know more @ Chronic Spontaneous Urticaria Pipeline Analysis, Key Companies and Futuristic Trends Chronic Spontaneous Urticaria Therapeutics Assessment The Chronic Spontaneous Urticaria Pipeline report proffers comprehensive coverage of the active pipeline candidates segmented by Stage, Product Type, Route of Administration, Molecule Type, Target, and Mechanism of Action. By Product Type By Stage By Molecule Type By Route of Administration By Mechanism of Action By Targets Connect with our Business Executive for Asset Prioritization Services and Consulting Solutions Scope of the Chronic Spontaneous Urticaria Pipeline Report Coverage: GlobalKey Players: Allakos, AstraZeneca, Biosana, Celldex Therapeutics, Celltrion, Eli Lilly and Company, Genentech, GI Innovation/Yuhan, GlaxoSmithKline, Glenmark Pharmaceuticals, Gossamer Bio, Kiniksa Pharmaceuticals, Mycenax Biotech, Novartis, Regeneron, Synermore Biologics, UCB Biopharma, United BioPharma, Amgen, and others. Key Chronic Spontaneous Urticaria Pipeline Therapies: UB-221, GBR 310, Ligelizumab, UCB8600, Antolimab, Dupilumab, GI-301, CDX-0159, LY3454738, Fenebrutinib, GS-4059, Nucala, SYN008, BP001, Tezepelumab and others. Reach out @ Chronic Spontaneous Urticaria Pipeline: Novel therapies and Emerging technologies Table of Contents Learn more about the report offerings @ Chronic Spontaneous Urticaria Emerging Therapies, Treatments and Ongoing Clinical Trials Related Reports Chronic Spontaneous Urticaria MarketDelveInsight’s ‘Chronic spontaneous urticaria (CSU) – Market Insights, Epidemiology, and Market Forecast—2030’ report. Chronic Inducible Urticaria Market ForecastDelveInsight’s ‘Chronic Inducible Urticaria Market Insights, Epidemiology, and Market Forecast-2030’ report. Scleroderma MarketDelveInsight's " Scleroderma Market Insights, Epidemiology, and Market Forecast-2030" report. Skin Neoplasms MarketDelveInsight's "Skin Neoplasms - Market Insights, Epidemiology, and Market Forecast-2030" report. Soft Tissue Defect MarketDelveInsight's "Soft Tissue Defect - Market Insights, Epidemiology, and Market Forecast-2030" report. Uremic Pruritus MarketDelveInsight's "Uremic Pruritus (UP) - Market Insights, Epidemiology, and Market Forecast-2030" report. Warts MarketDelveInsight's "Warts Market Insights, Epidemiology, and Market Forecast-2030" report. Related Posts Highlights from ASCO20218 most common allergensDeadliest infectious diseasesChronic Hand Eczema Market Analysis and Forecast About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. For more insights, visit Pharma, Healthcare, and Biotech News

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic Urticaria	Phase 1	KR	Yuhan Corp.	23 Aug 2023
Anaphylaxis	Phase 1	KR	Yuhan Corp.	26 Sep 2021

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AAAAI2024	Not Applicable	serum total IgE levels	-	YH35324 6 mg/kg	upjqewthbb(evktlqamtb) = There were no anaphylaxis after the YH35324 treatment szlejbdhmb (clawdvfkwz ) View more	Positive	23 Feb 2024
				Omalizumab 300 mg
NCT05061524 (Pubmed) Manual	Phase 1	Anaphylaxis	68	YH35324 (Part A)	uudkcfglze(zhhuuwxgkz) = mostly grade 1/2 dfhpqubxrw (wcmlyhdhgu ) View more	Positive	20 Feb 2024
				omalizumab (Part A)

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