A Phase I, Randomized, Single-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UB-221 as an Add-on Therapy in Patients With Chronic Spontaneous Urticaria

The study is to evaluate the profiles of safety, tolerability, pharmacokinetics, and pharmacodynamics of UB-221. In this study, safety profile of UB-221 and maximum tolerated dose (MTD) is to be investigated using sentinel dosing strategy. The starting dose of 0.2 mg/kg is selected based on the evaluation and comparison of various approaches including NOAEL, MABEL (minimum anticipated biological effect level), and experiences from other anti-IgE mAb drugs in development.

Start Date30 Dec 2023

Sponsor / Collaborator

United BioPharma, Inc.

CTR20233674 / RecruitingPhase 2

一项 II 期、多中心、随机、双盲、安慰剂对照、平行组研究，以评估 UB-221作为添加疗法在慢性自发性荨麻疹(CSU) 患者中的疗效，安全性，药代动力学和药效学

[Translation] A Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of UB-221 as add-on therapy in patients with chronic spontaneous urticaria (CSU)

主要目的：评估 CSU 患者中各种 UB-221SC 剂量与安慰剂相比的疗效。次要目的：评估 CSU 患者中不同剂量队列的疗效；评估研究药物首次给药后至完全缓解（UAS7=0）、UAS7≤6和首次复发时间方面的疗效；评估UB-221 SC 对于首次给药后至首次使用补救药物时间、补救药物使用天数和每周使用补救药物的片剂数量方面的疗效；评估 CSU 患者中不同剂量队列的安全性和耐受性；CSU 患者中 UB-221 SC 的药代动力学（PK）；CSU 患者中不同剂量队列的药效学（PD）；CSU 患者中不同剂量队列的免疫原性；评估 CSU 患者不同剂量组的皮肤病生活质量指数(DLQI)。探索性目的：探索 UB-221 SC 在 CSU 患者中的作用机制。

[Translation]

Primary Objective: To evaluate the efficacy of various UB-221SC doses compared to placebo in CSU patients. Secondary Objectives: To evaluate the efficacy of different dose cohorts in CSU patients; To evaluate the efficacy of the study drug in terms of time to complete remission (UAS7=0), UAS7≤6, and first relapse after the first dose; To evaluate the efficacy of UB-221 SC in terms of time to first rescue medication use after the first dose, number of rescue medication use days, and number of rescue medication tablets per week; To evaluate the safety and tolerability of different dose cohorts in CSU patients; Pharmacokinetics (PK) of UB-221 SC in CSU patients; Pharmacodynamics (PD) of different dose cohorts in CSU patients; Immunogenicity of different dose cohorts in CSU patients; To evaluate the Dermatology Life Quality Index (DLQI) of different dose groups in CSU patients. Exploratory Objectives: To explore the mechanism of action of UB-221 SC in CSU patients.

Start Date22 Dec 2023

Sponsor / Collaborator

Liansheng Pharmaceutical (Yangzhou) Biomedical Co., Ltd.

NCT04404023 / Not yet recruitingPhase 1

A Phase I, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of a Single Dose of UB-221 in Healthy Volunteers

The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single dose of UB-221 in healthy volunteers.

Start Date01 Dec 2023

Sponsor / Collaborator

UBP Greater China Holdings Limited

100 Clinical Results associated with UB-221

100 Translational Medicine associated with UB-221

100 Patents (Medical) associated with UB-221

Literatures (Medical) associated with UB-221

01 Jun 2024·Current Opinion in Allergy & Clinical Immunology

New biologics for food allergy

Review

Author: Schuetz, Jackson P. ; Sindher, Sayantani B. ; Anderson, Brent

Purpose of reviewThis review aims to explore role of emerging biologics, including ligelizumab, UB-221, dupilumab, and antialarmins, in food allergy management. With a focus on recent developments, we evaluate their promise in mitigating adverse events during oral immunotherapy (OIT), reducing allergic reactions, and addressing the limitations of current therapeutic options.Recent findingsAntiimmunoglobulin E mAbs, exemplified by omalizumab, demonstrate efficacy in desensitization and safety improvement during multiallergen OIT. Next-generation antibodies like ligelizumab and UB-221 exhibit enhanced potency and unique mechanisms, holding promise for food allergy treatment. Dupilumab, targeting IL-4 receptor alpha, presents potential benefits in decreasing allergen-specific IgE and modifying the atopic march. Exploration of antialarmins, specifically anti-IL-33 (etokimab) and anti-TSLP (tezepelumab), reveals encouraging results, with etokimab showing early success in peanut allergy trials.SummaryBiologics hold promising potential for food allergy treatment. Tailoring therapeutic approaches based on shared decision-making becomes pivotal. While omalizumab remains a significant option, next-generation anti-IgE antibodies and agents targeting alarmins exhibit unique strengths. Dupilumab, despite limited success as monotherapy, shows promise as an adjunct for OIT. Careful consideration of treatment goals, patient preferences, and the evolving landscape of biologics will shape future clinical practice, offering allergists an expanded toolbox for personalized food allergy management.

01 Aug 2022·Journal of Clinical Investigation

IgE-neutralizing UB-221 mAb, distinct from omalizumab and ligelizumab, exhibits CD23-mediated IgE downregulation and relieves urticaria symptoms

Article

Author: Tsai, Pei-Hua ; Shiung, Yu-Yu ; Liu, Yaw-Jen ; Lin, Chen-Han ; Hsu, Cindy ; Lynn, Shugene ; Ho, Yueh-Feng ; Huang, Hong-Xuan ; Lai, Annie ; Lee, Chih-Hung ; Li, Chao-Hung ; Chu, Chia-Yu ; Chang, Heng-Kwei ; Liao, Mei-June ; Kuo, Be-Sheng ; Wang, Yi-Jen ; Kuo, Je-Hung ; Lin, Chia-Yin ; Tseng, William ; Li, Ywan-Feng ; Lung, Meng-Chung ; Cheng, Yi-Ning ; Chen, Techeng ; Chen, Jiun-Bo ; Yang, Fu-Hung ; Wu, Ming-Syue ; Wang, Chang Yi ; Yang, Jasper ; Su, Hsiao-Wen

Over the last 2 decades, omalizumab is the only anti-IgE antibody that has been approved for asthma and chronic spontaneous urticaria (CSU). Ligelizumab, a higher-affinity anti-IgE mAb and the only rival viable candidate in late-stage clinical trials, showed anti-CSU efficacy superior to that of omalizumab in phase IIb but not in phase III. This report features the antigenic-functional characteristics of UB-221, an anti-IgE mAb of a newer class that is distinct from omalizumab and ligelizumab. UB-221, in free form, bound abundantly to CD23-occupied IgE and, in oligomeric mAb-IgE complex forms, freely engaged CD23, while ligelizumab reacted limitedly and omalizumab stayed inert toward CD23; these observations are consistent with UB-221 outperforming ligelizumab and omalizumab in CD23-mediated downregulation of IgE production. UB-221 bound IgE with a strong affinity to prevent FcԑRI-mediated basophil activation and degranulation, exhibiting superior IgE-neutralizing activity to that of omalizumab. UB-221 and ligelizumab bound cellular IgE and effectively neutralized IgE in sera of patients with atopic dermatitis with equal strength, while omalizumab lagged behind. A single UB-221 dose administered to cynomolgus macaques and human IgE (ε, κ)-knockin mice could induce rapid, pronounced serum-IgE reduction. A single UB-221 dose administered to patients with CSU in a first-in-human trial exhibited durable disease symptom relief in parallel with a rapid reduction in serum free-IgE level.

04 Mar 2022·Expert Opinion on Investigational DrugsQ2 · MEDICINE

Emerging treatments for chronic urticaria

Q2 · MEDICINE

Review

Author: Wedi, Bettina

INTRODUCTIONAcross the globe, chronic urticaria (CU), i.e. chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CINDU), is common, long-persisting and difficult to manage. Still, at least one-fifth is not sufficiently controlled by guideline-recommended treatment with H1-antihistamines and add-on therapy with the anti-IgE monoclonal antibody omalizumab.AREAS COVEREDUsing PubMed, ClinicalTrials.gov, Congress websites, and websites of the manufacturers, this review explored the pipeline, namely anti-IgE-, anti-cytokine-, anti-receptor biologics, and small molecules, in clinical development for CU.EXPERT OPINIONThe CU pipeline is promising. While three omalizumab biosimilars are investigated, the assumed early approval of ligelizumab will expand the effective and safe anti-IgE approach observed with omalizumab. For other anti-IgEs like UB-221, the development is behind. Data are too limited so far to clearly define the role of anti-cytokine and anti-cytokine receptor biologics such as dupilumab, tezepelumab, mepolizumab, benralizumab, and CDX-0159, of which only dupilumab is actually investigated in phase 3. Among three selective oral BTK inhibitors, remibrutinib, rilzabrutinib, and fenebrutinib, the development of remibrutinib is most advanced (phase 3). As the pipeline addresses different targets, study results will give deeper insights into the pathomechanisms of CU. Hopefully, in the next future additional approved and also more targeted approaches will be available.

News (Medical) associated with UB-221

08 Aug 2022

·www.prnewswire.com

United BioPharma's Study Reveals New Class of Monoclonal Antibody for Effective Relief of Urticaria Symptoms

TAIPEI, Aug. 5, 2022 /PRNewswire/ -- United BioPharma (UBP) today announced their latest results featuring unprecedented and unique functional characteristics of UB-221 monoclonal antibody in the phase I single-dose clinical trial, with chronic spontaneous urticaria (CSU) patients, to exhibit durable disease symptom relief. The results were published in the latest Journal of Clinical Investigation (JCI). A New Treatment Option for CSU The chronic spontaneous urticaria (CSU) has known to be caused by a type of protein or antibodies produced by the immune system, known as Immunoglobulin E (IgE). While the existing approved CSU therapy (omalizumab; Xolair® ) and investigational drug (ligelizumab), have exerted positive reaction to reduce the disease symptoms over the last two decades, United BioPharma's latest results have shown that the potential of a newer class of anti-IgE monoclonal antibody UB-221 has superior efficacy in CSU and can prolong the suppression of the disease symptoms. In the study, UB-221 has proven to be a potent IgE neutralizer and a significant inhibitor of IgE neo-synthesis. Meaning, UB-221 binds IgE with a higher affinity and inhibits IgE production at a far greater scale in comparison with other anti-IgE antibodies like omalizumab and ligelizumab. The study also suggests this new class of monoclonal antibody shows promise for the prevention of the development of allergic symptoms, through targeting both high-affinity IgE receptor (FcϵRI) and low affinity IgE receptor (CD23) pathways. In addition, a notable observation of the study is that UB-221 in free form can interact unrestricted with CD23. This unprecedented feature not found in any other anti-IgE antibodies, supports the contention that it could be of benefit to target IgE toward the non-inflammatory CD23 pathway. In other words, UB-221 can down-regulate IgE production and reduce serum IgE levels in urticaria patients. Other findings highlighted from the data published in the JCI include: In studies with animal models, such as cynomolgus macaques and human IgE (ε, κ)-transgenic hIGHE (immunoglobulin heavy epsilon)-knockin mice, a single dose of UB-221 can induce a rapid, profound reduction of serum IgE. The prolong suppression of urticaria symptoms and reduction of serum IgE levels suggests that a single dose of >2.0 mg/kg could potentially allow UB-221 to be administered every 3 to 6 months and achieve complete response (UAS7 = 0) or well controlled stage (UAS7 ≤ 6) in the treatment of CSU. Advances in UB-221 for Allergic Diseases Recent studies have shown that the combined prevalence of allergic diseases has increased to affect more than 30% of the world population. The condition underscores unmet medical need, burden on healthcare systems and the global economy as well. In response to the situation, UB-221 is being developed as therapeutic biologics. It aims to treat various types of allergic (atopic) diseases, including chronic spontaneous urticaria, food allergy, atopic dermatitis, asthma, and allergic rhinitis. About United BioPharma United BioPharma (UBP) is a late clinical stage biopharmaceutical company that is dedicated to the research, development and manufacture of novel monoclonal antibodies (mAbs) for infectious and immunological diseases. UBP is headquartered in Taiwan, with subsidiary companies in Shanghai and Yangzhou China, and liaison offices in the U.S. The company has built a passionate global team, developing high-quality therapeutic mAbs and delivering affordable treatments to bring the patients better quality of life. For more information, please visit the website at: http://www.unitedbiopharma.com

AntibodyCollaborate

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

100 Deals associated with UB-221

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic Urticaria	Phase 2	TW	United BioPharma, Inc.	05 Oct 2022
Allergic asthma	Discovery	TW	United BioPharma, Inc.	08 Nov 2019
Allergic asthma	Discovery	TW	Academia Sinica	08 Nov 2019
Dermatitis, Atopic	Discovery	TW	Academia Sinica	08 Nov 2019
Dermatitis, Atopic	Discovery	TW	United BioPharma, Inc.	08 Nov 2019
Food Hypersensitivity	Discovery	TW	United BioPharma, Inc.	08 Nov 2019
Food Hypersensitivity	Discovery	TW	Academia Sinica	08 Nov 2019
Rhinitis, Allergic	Discovery	TW	Academia Sinica	08 Nov 2019
Rhinitis, Allergic	Discovery	TW	United BioPharma, Inc.	08 Nov 2019

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