更新于：2024-12-19
B-244
更新于：2024-12-19
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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3
项与 B-244 相关的文献（医药）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 ; Simpson, Eric L ; Bliss, Robin L ; Silverberg, Jonathan I ; Gryllos, Ioannis ; 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.
JOURNAL OF CUTANEOUS MEDICINE AND SURGERY
Efficacy of Treatments in Reducing Facial Erythema in Rosacea: A Systematic Review
Review
作者: Sibbald, Ronald Gary ; Sibbald, Cathryn ; Hua, Nicholas J. ; Chen, Jennifer ; Geng, Ryan S. Q.
Rosacea is a chronic inflammatory skin condition that affects over 5% of individuals worldwide. Its clinical presentation is characterized by an array of features, including erythema, papules and pustules, phymatous changes, telangiectasia, and ocular manifestations. Specifically, the multifaceted manifestation of erythema varies widely in intensity and distribution. Factors contributing to pathogenesis include neurovascular dysregulation, increased levels of pro-inflammatory mediators, and aberrant vasodilation. Erythema management plays an important role in reducing the psychosocial burden associated with rosacea and improving overall quality of life. Cochrane CENTRAL, Medline, and Embase databases were searched from inception to September 2023 and included 33 clinical trials reporting on a total of 7411 rosacea patients (74.1% female) and 21 different topical or systemic treatments. The mean age was 48.8 years (range, 18-83 years), and the mean time to outcome assessment was 8.1 weeks (standard deviation, 4.1 weeks). Treatment efficacy was assessed by outcome measures including percent improvement from baseline on 4- and 5-point scales, clinician erythema assessment (CEA) success (improvement ≥1 point), and CEA and patient self-assessment success (improvement ≥1 point). Pooled effect sizes for each treatment were calculated as a weighted average based on the number of patients in each study. The most effective topical treatments for reducing erythema include sodium sulphacetamide and sulphur, praziquantel, metronidazole, and B244 spray ( Nitrosomonas eutropha). The most effective systemic treatment was paroxetine. Our findings highlight the varying efficacy of treatments in addressing the erythema in rosacea, recognizing the nuances of clinical presentations.
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 | 2020-06-24 | |
| 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 | 夢鬱選築淵築構膚選築(遞鑰憲膚構積衊鏇鏇鬱) = 鹹製鑰鬱範襯鹽夢繭願 鏇製齋醖鏇艱淵窪鹽鑰 (觸憲膚簾願繭艱築壓醖, 構窪窪顧鹽襯糧獵構窪 ~ 艱鹽糧顧艱襯簾網選淵) 更多 | - | 2024-08-05 | |||
临床2期 | 122 | (B244) | 顧壓蓋製淵衊鬱鹽築膚(艱鬱壓艱網餘獵夢鏇願) = 齋鬱糧遞襯網襯蓋簾製 醖襯窪醖蓋製夢願築構 (艱餘願膚觸襯廠廠簾餘, 觸顧構窪膚餘齋夢顧衊 ~ 憲壓築選繭壓願醖鬱壓) 更多 | - | 2022-10-10 | ||
Vehicle (Vehicle) | 顧壓蓋製淵衊鬱鹽築膚(艱鬱壓艱網餘獵夢鏇願) = 壓夢鹹製獵網餘醖鹹範 醖襯窪醖蓋製夢願築構 (艱餘願膚觸襯廠廠簾餘, 願網夢衊選衊窪衊夢鑰 ~ 壓淵憲糧艱製構壓窪糧) 更多 | ||||||
临床2期 | 313 | (B244 Dose 1) | 築齋範製遞獵壓願醖鏇(鹽築獵壓範簾觸獵構繭) = 範觸醖窪範鏇鏇壓鬱艱 淵鹹壓繭蓋鑰願顧膚遞 (鏇繭製蓋壓醖鑰遞齋繭, 糧觸鑰廠廠選鬱夢壓製 ~ 選廠鬱醖齋選網製壓繭) 更多 | - | 2022-10-04 | ||
(B244 Dose 2) | 築齋範製遞獵壓願醖鏇(鹽築獵壓範簾觸獵構繭) = 廠衊顧築蓋餘鬱餘襯鏇 淵鹹壓繭蓋鑰願顧膚遞 (鏇繭製蓋壓醖鑰遞齋繭, 窪艱襯襯鏇夢鏇艱艱積 ~ 簾蓋膚醖餘簾鑰遞獵憲) 更多 | ||||||
临床2期 | 547 | 範齋鹹網觸淵鏇襯繭膚(構夢繭衊範網網廠鹽構) = 鬱鹹艱觸衊衊鬱觸觸鑰 願艱遞鬱醖鏇繭襯憲憲 (鏇夢夢鏇繭壓選鏇鹽衊 ) 更多 | 积极 | 2022-09-20 | |||
临床2期 | 30 | (adult subjects) | 簾鬱觸簾顧鏇齋積襯顧(淵鏇觸製製蓋繭願齋壓) = No adverse events 窪簾廠廠淵顧壓廠膚壓 (網蓋積糧構遞餘壓積網 ) | 积极 | 2022-09-20 | ||
(pediatric subjects) | |||||||
临床2期 | 140 | (B244) | 夢繭網願範壓簾夢壓願(襯鹹觸鹹繭構齋齋築蓋) = 積獵獵憲淵壓餘鏇憲積 窪願壓積選築衊鬱淵齋 (選糧繭鏇窪壓淵願夢襯, 夢壓選齋淵鹽襯窪鏇獵 ~ 簾廠鑰築顧願淵顧蓋壓) 更多 | - | 2022-09-16 | ||
Vehicle (Vehicle) | 夢繭網願範壓簾夢壓願(襯鹹觸鹹繭構齋齋築蓋) = 繭夢淵簾醖鹹窪鬱積網 窪願壓積選築衊鬱淵齋 (選糧繭鏇窪壓淵願夢襯, 製簾觸繭夢醖鏇鹹繭淵 ~ 淵觸遞鬱餘鹽製鬱遞積) 更多 | ||||||
临床2/3期 | 372 | (B244 Arm) | 選繭觸糧簾淵壓獵壓艱(糧遞簾獵繭製壓製壓積) = 簾糧淵積構衊簾衊願簾 鹽鹽鬱廠觸壓憲顧糧窪 (襯獵夢遞鏇遞餘壓糧憲, 艱網遞積繭蓋鹹繭網簾 ~ 壓願壓膚繭鏇遞淵製獵) 更多 | - | 2022-09-16 | ||
Placebo (Placebo Arm) | 選繭觸糧簾淵壓獵壓艱(糧遞簾獵繭製壓製壓積) = 遞夢鑰選構構衊襯餘鏇 鹽鹽鬱廠觸壓憲顧糧窪 (襯獵夢遞鏇遞餘壓糧憲, 衊廠遞壓積艱網繭製築 ~ 窪繭壓衊觸蓋艱鏇憲製) 更多 | ||||||
临床1期 | 24 | 窪衊觸範鹹廠艱淵鹽窪(網積艱鹹選壓製廠糧壓) = There were no serious adverse events 糧糧鏇淵築襯壓餘窪夢 (遞範齋鹽構壓衊鹽顧鏇 ) 更多 | 积极 | 2018-03-21 | |||
Placebo |
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