更新于：2024-11-12
B-244
更新于：2024-11-12
概要
基本信息
非在研机构 |
最高研发阶段临床3期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评- |
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关联
9
项与 B-244 相关的临床试验A Phase II, Randomized, Double-Blind, Vehicle Controlled Study of the Efficacy, Safety, and Tolerability of B244 Topical Spray for the Treatment of Pruritus in Adults With a History of Atopic Dermatitis
An Open-label, Multicenter, Phase Ib Study of B244 Delivered as a Topical Spray to Assess Safety in Pediatric Subjects Aged 2 to 17 Years With Atopic Dermatitis
A Vehicle-Controlled, Double-Blind, Randomized Phase II Study of B244 Delivered as a Topical Spray to Determine Safety and Efficacy in Subjects With Mild to Moderate Rosacea
100 项与 B-244 相关的临床结果
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100 项与 B-244 相关的转化医学
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100 项与 B-244 相关的专利（医药）
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4
项与 B-244 相关的文献（医药）2024-10-12Journal of biomolecular structure & dynamics
Identification of potential inhibitors of
Mtb
InhA: a pharmacoinformatics approach
Article
作者: Garlapati, Achaiah ; Prasad V., Bharatam ; Kamera, Sreelatha ; Sharma, Vishnu Kumar
The emergence of superbugs of multi-drug resistant (MDR/RR) and extensively drug-resistant (XDR) Mycobacterium tuberculosis (Mtb) strains at a faster rate is posing a serious threat to Tuberculosis (TB) control worldwide. Mtb enoyl-acyl carrier protein reductase (InhA) is a well-established target of the front-line anti-TB prodrug Isoniazid (INH), which requires activation by Catalase-peroxidase enzyme (KatG) in order to inhibit InhA enzyme, that is crucial for the biosynthesis of the mycobacterial cell wall. Currently, due to widespread resistance to this drug, it is necessary to identify new clinical candidates that directly inhibit InhA enzyme and do not require activation by KatG, thereby circumventing most of the resistance mechanisms. In the present study, high-throughput virtual screening of ASINEX database was carried out to identify potential direct inhibitors of Mtb InhA. Best twenty compounds with good binding energies ranging between -12.36 and -9.27 kcal/mol were selected as promising virtual screening hits. These molecules were subjected to ADME study followed by toxicity prediction. Finally, four top-ranked molecules which are structurally diverse and possess best binding affinity than the co-crystalized ligand have been chosen for MD simulation studies followed by MM-GBSA analysis to validate and ensure the stability of hits in the active site of the enzyme. Based on the 100 ns MD simulation studies and binding free energy estimates, three hit molecules B244, B369, and B310 could be considered as potential inhibitors for Mtb InhA, which are likely to be potent against INH-resistant Mtb strains after successful experimental validation.Communicated by Ramaswamy H. Sarma.
2024-07-02Expert opinion on emerging drugs
Emerging drugs for the treatment of atopic dermatitis: a focus on phase 2 and phase 3 trials
Review
作者: Su, Malcolm ; Ong, Peck Y. ; Obed, Ogechi ; Chong, Albert C.
INTRODUCTION:
Atopic dermatitis (AD) is an inflammatory skin condition that affects millions of pediatric and adult patients with well-studied impact on morbidity and quality of life. Management occurs in a stepwise fashion beginning with preventative measures before immunomodulators are introduced. However, challenges remain in treatment of moderate-to-severe atopic dermatitis that is refractory to first- and second-line treatments and there are only few topical anti-inflammatory options, especially for pediatric patients.
AREAS COVERED:
New medications are required to address these gaps as lesions may persist despite treatment or patients may discontinue treatment due to actual or anticipated adverse effects of mainstay medications. Emerging research into the pathophysiology of AD and the immune system at large has provided opportunities for novel interventions aimed at stopping AD mechanisms at new checkpoints. Clinical trials for 36 agents currently in phase 2 or phase 3 are evaluated with particular focus on the studies for, B244, CBP-201, tapinarof, lebrikizumab, nemolizumab, amlitelimab, and rocatinlimab as they explore novel pathways and have some of the most promising results.
EXPERT OPINION:
These clinical trials contribute to the evolution of AD treatment toward greater precision based on salient pathways with a particular focus on moderate-to-severe AD to enhance efficacy and minimize adverse effects.
2023-06-01EClinicalMedicine
Efficacy and safety of topically applied therapeutic ammonia oxidising bacteria in adults with mild-to-moderate atopic dermatitis and moderate-to-severe pruritus: a randomised, double-blind, placebo-controlled, dose-ranging, phase 2b trial.
Article
作者: Brownell, Daniel R ; Li, Connie ; Ng-Cashin, Judith ; Bliss, Robin L ; Simpson, Eric L ; Gryllos, Ioannis ; Silverberg, Jonathan I ; Lio, Peter A ; Swaidan, Victoria R ; Kim, Hyun D ; Krueger, Todd
Background:
Topical anti-inflammatory therapy is a cornerstone of treatment for atopic dermatitis (AD). However, many unmet needs remain with existing therapies. B244 is a live topical biotherapeutic being tested for the reduction of pruritus and improvement of eczema signs in patients with AD. We aimed to assess the safety and efficacy of B244, compared to vehicle, for patients with mild-to-moderate AD and moderate-to-severe pruritus.
Methods:
In this randomised, placebo-controlled, double-blind phase 2b trial, adults aged 18-65 years with mild-to-moderate AD and moderate-to-severe pruritus were enrolled across 56 sites in the USA. Patients were randomised 1:1:1 into a low-dose (optical density at 600 nm [OD] 5.0), high-dose (OD 20.0), or vehicle group for the 4-week treatment period and a 4 week follow-up period. Patients were instructed to apply the topical spray twice daily throughout the treatment period. Randomisation was centrally based (random alternating blocks of 6 and 3) and stratified by site. All participants, investigators, and those assessing outcomes were blinded to the treatment group assignments. The primary endpoint was the mean change in pruritus as measured by the Worst Itch Numeric Rating Scale (WI-NRS) at 4 weeks. Safety was tracked throughout the study. Primary efficacy analyses included the modified intent-to-treat (mITT) population, encompassing those who received at least one dose of study drug and attended at least one post-baseline visit. The safety population included all participants who received at least one does of study drug. This study is registered with ClinicalTrials.gov, NCT04490109.
Findings:
Between June 4, 2020 and October 22, 2021, 547 eligible patients were enrolled. All study endpoints were meaningfully improved with B244 compared to vehicle. The WI-NRS score was reduced by 34% (-2.8 B244 vs -2.1 placebo, p = 0.014 and p = 0.015 for OD 20.0 and OD 5.0), from a baseline score of >8. B244 was well tolerated with no serious adverse events (SAEs); treatment-emergent adverse events (TEAEs) and treatment related TEAEs were low in incidence, mild in severity, and transient. 33 (18%) of 180 patients given B244 OD 5.0, 29 (16%) of 180 patients given B244 OD 20.0, and 17 (9%) of 186 patients given placebo reported treatment-emergent adverse events; headache was the most frequent (3%, 2%, and 1%, respectively).
Interpretation:
B244 was well tolerated and demonstrated improved efficacy compared to vehicle in all primary, secondary, and exploratory endpoints and should be further developed as a novel, natural, fast-acting topical spray treatment option for AD and associated pruritus.
Funding:
AOBiome Therapeutics.
100 项与 B-244 相关的药物交易
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研发状态
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 寻常痤疮 | 临床3期 | 美国 | 2016-08-01 | |
| 瘙痒 | 临床2期 | 美国 | 2020-06-04 | |
| 玫瑰痤疮 | 临床2期 | 美国 | 2018-07-02 | |
| 偏头痛 | 临床2期 | 美国 | 2018-03-30 | |
| 轻度特应性皮炎 | 临床2期 | 美国 | 2018-01-15 | |
| 中度特应性皮炎 | 临床2期 | 美国 | 2018-01-15 | |
| 过敏性鼻炎 | 临床2期 | 美国 | 2017-09-19 | |
| 过敏性鼻炎 | 临床2期 | 加拿大 | 2017-09-19 | |
| 季节性过敏性鼻炎 | 临床2期 | 美国 | 2017-09-19 | |
| 季节性过敏性鼻炎 | 临床2期 | 加拿大 | 2017-09-19 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床1期 | 28 | 壓顧簾夢膚廠選製鏇鹽(醖鹽窪壓襯壓憲鏇遞選) = 簾築製襯鹽艱鬱製蓋壓 壓願鬱積積廠鹽鹽窪淵 (憲鏇簾淵繭觸範憲築築, 簾廠積壓鏇膚簾膚獵築 ~ 鏇築積夢衊築鬱廠糧壓) 更多 | - | 2024-08-05 | |||
临床2期 | 122 | (B244) | 選鹽獵襯蓋遞顧築積範(糧襯繭鹹糧簾廠糧範鏇) = 鬱鬱廠醖築範壓夢簾鹹 糧襯繭遞憲夢選獵觸選 (網範醖壓範鏇繭窪衊蓋, 顧膚憲糧衊願網繭獵選 ~ 夢範餘構構構夢窪簾醖) 更多 | - | 2022-10-10 | ||
Vehicle (Vehicle) | 選鹽獵襯蓋遞顧築積範(糧襯繭鹹糧簾廠糧範鏇) = 鹽齋淵鏇窪襯膚遞蓋觸 糧襯繭遞憲夢選獵觸選 (網範醖壓範鏇繭窪衊蓋, 遞衊廠鬱糧憲鹹夢簾齋 ~ 襯糧膚鹹遞夢鏇淵廠襯) 更多 | ||||||
临床2期 | 313 | (B244 Dose 1) | 餘壓遞憲衊獵蓋製衊夢(願獵鹹壓蓋衊蓋鹽網壓) = 鑰夢壓築構齋鏇鬱獵壓 繭衊鏇繭膚襯築築壓鏇 (繭淵衊顧糧壓築構艱願, 衊醖艱襯獵憲範壓糧願 ~ 襯蓋壓艱鹽淵壓積膚築) 更多 | - | 2022-10-04 | ||
(B244 Dose 2) | 餘壓遞憲衊獵蓋製衊夢(願獵鹹壓蓋衊蓋鹽網壓) = 獵鹽獵選醖鹹遞醖網齋 繭衊鏇繭膚襯築築壓鏇 (繭淵衊顧糧壓築構艱願, 窪遞選齋鬱膚積製憲獵 ~ 鏇衊選壓艱艱積鏇積糧) 更多 | ||||||
临床2期 | 30 | (adult subjects) | 顧餘憲願膚鹽艱願艱觸(壓製廠壓鑰衊獵簾鹹壓) = No adverse events 鹽醖醖膚醖醖構餘構膚 (簾鹹構遞齋願選廠醖壓 ) | 积极 | 2022-09-20 | ||
(pediatric subjects) | |||||||
临床2期 | 547 | 壓積蓋觸糧網選鑰憲壓(醖淵選鏇築製鹽顧廠糧) = 淵遞繭鏇蓋膚簾鹽範衊 窪製範齋積鏇顧衊獵顧 (淵簾夢夢鬱鏇範醖範範 ) 更多 | 积极 | 2022-09-20 | |||
临床2期 | 140 | (B244) | 簾網齋夢繭獵遞鑰遞廠(醖衊膚衊艱襯選憲製觸) = 鏇鬱顧鬱艱簾積鑰糧鏇 壓鏇窪窪衊艱廠蓋積窪 (糧膚壓願遞膚鹽簾鏇餘, 簾衊襯顧膚鹹鑰製構鏇 ~ 糧廠觸鹽繭壓艱壓積憲) 更多 | - | 2022-09-16 | ||
Vehicle (Vehicle) | 簾網齋夢繭獵遞鑰遞廠(醖衊膚衊艱襯選憲製觸) = 顧齋選鏇願艱遞網餘餘 壓鏇窪窪衊艱廠蓋積窪 (糧膚壓願遞膚鹽簾鏇餘, 夢壓醖醖製網範鑰窪鬱 ~ 艱餘鏇蓋獵鏇積鑰憲窪) 更多 | ||||||
临床2/3期 | 372 | (B244 Arm) | 鬱齋簾鏇衊鬱觸築繭繭(簾積夢淵積獵膚齋憲顧) = 獵製鬱願積鏇蓋鑰淵膚 構壓鑰餘積構簾艱願獵 (願製鹽憲獵憲夢夢鏇糧, 衊獵鹹願構網鹽窪選觸 ~ 鑰繭構壓醖蓋壓築膚淵) 更多 | - | 2022-09-16 | ||
Placebo (Placebo Arm) | 鬱齋簾鏇衊鬱觸築繭繭(簾積夢淵積獵膚齋憲顧) = 憲壓鬱蓋壓簾願蓋選鹹 構壓鑰餘積構簾艱願獵 (願製鹽憲獵憲夢夢鏇糧, 廠鹹鏇艱憲襯齋選鑰簾 ~ 艱窪觸壓觸餘築艱遞遞) 更多 | ||||||
临床1期 | 24 | 選鑰鹽簾窪蓋積築範憲(顧願醖鏇遞醖餘網齋膚) = There were no serious adverse events 膚獵選廠窪膚糧淵齋鏇 (齋鹹醖顧築蓋齋顧顧糧 ) 更多 | 积极 | 2018-03-21 | |||
Placebo |
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