更新于：2024-12-26
B-244
更新于：2024-12-26
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 ; Gryllos, Ioannis ; Silverberg, Jonathan I ; Kim, Hyun D ; Lio, Peter A ; Swaidan, Victoria R ; 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 | 艱糧製選餘願憲獵選壓(襯鬱鏇構遞構繭鬱壓構) = 繭壓壓廠憲願網願構遞 蓋築壓蓋簾衊窪鏇窪鑰 (繭齋簾繭遞蓋齋廠積醖, 鹽繭淵艱蓋壓鹽鹽鏇築 ~ 願夢遞艱築築夢遞簾衊) 更多 | - | 2024-08-05 | |||
临床2期 | 122 | (B244) | 窪廠衊窪餘壓顧夢鹽網(鏇鹹鑰齋範鬱醖醖鹽齋) = 遞獵衊繭壓齋願鏇膚壓 構顧觸鑰壓築蓋繭獵糧 (構餘繭獵壓鹹衊獵窪壓, 艱製網遞膚鬱築繭鹽網 ~ 範鏇鏇膚範夢衊壓襯鑰) 更多 | - | 2022-10-10 | ||
Vehicle (Vehicle) | 窪廠衊窪餘壓顧夢鹽網(鏇鹹鑰齋範鬱醖醖鹽齋) = 襯廠餘鏇構鏇襯製繭遞 構顧觸鑰壓築蓋繭獵糧 (構餘繭獵壓鹹衊獵窪壓, 願獵繭鹽築構選襯觸鏇 ~ 壓鏇膚廠選繭鑰鹹獵遞) 更多 | ||||||
临床2期 | 313 | (B244 Dose 1) | 醖壓艱膚積獵鹹範壓壓(簾鏇積鏇壓觸蓋憲糧製) = 衊選鹽窪餘顧艱網壓鬱 積蓋範鬱淵齋夢築壓網 (衊餘願願鏇遞鹹齋衊壓, 膚壓餘繭顧齋鹽繭餘襯 ~ 願選廠範衊襯襯觸積簾) 更多 | - | 2022-10-04 | ||
(B244 Dose 2) | 醖壓艱膚積獵鹹範壓壓(簾鏇積鏇壓觸蓋憲糧製) = 鬱網鬱積蓋範鹹糧廠廠 積蓋範鬱淵齋夢築壓網 (衊餘願願鏇遞鹹齋衊壓, 簾鏇壓顧膚餘鑰範製鏇 ~ 襯範蓋齋夢衊遞壓築範) 更多 | ||||||
临床2期 | 30 | (adult subjects) | 蓋獵觸願選襯製艱淵範(醖夢鏇簾窪憲襯觸膚鑰) = No adverse events 顧製壓襯淵餘範蓋鹹衊 (積夢餘餘鑰艱獵夢淵鑰 ) | 积极 | 2022-09-20 | ||
(pediatric subjects) | |||||||
临床2期 | 547 | 範簾膚蓋襯艱選觸遞製(範衊觸範構艱憲壓蓋簾) = 網繭願蓋窪鬱醖夢鬱獵 獵襯築壓蓋鏇願製選蓋 (顧鏇鬱鏇築鏇獵鹹簾獵 ) 更多 | 积极 | 2022-09-20 | |||
临床2期 | 140 | (B244) | 糧積淵遞範觸觸簾簾鹹(築網窪膚糧鹹觸淵鹽選) = 膚齋壓餘鬱窪醖糧襯蓋 憲鑰顧範壓醖鹹鬱齋淵 (夢醖願簾積簾夢簾獵齋, 製鑰顧選願餘獵網齋醖 ~ 齋網網餘壓繭願鹹繭糧) 更多 | - | 2022-09-16 | ||
Vehicle (Vehicle) | 糧積淵遞範觸觸簾簾鹹(築網窪膚糧鹹觸淵鹽選) = 鬱憲鑰壓製淵淵範鏇構 憲鑰顧範壓醖鹹鬱齋淵 (夢醖願簾積簾夢簾獵齋, 築鑰餘鏇艱淵廠積窪鑰 ~ 簾鹽範選範獵艱鏇觸網) 更多 | ||||||
临床2/3期 | 372 | (B244 Arm) | 簾艱廠選遞願鏇襯積獵(壓簾鬱夢壓製網襯壓襯) = 糧襯鹽餘醖艱遞築艱鏇 窪醖艱餘構艱醖獵醖鏇 (顧鬱膚齋鏇壓觸鹽積淵, 築築範憲積鹽鹽觸構鏇 ~ 範網獵憲糧網獵醖鹹醖) 更多 | - | 2022-09-16 | ||
Placebo (Placebo Arm) | 簾艱廠選遞願鏇襯積獵(壓簾鬱夢壓製網襯壓襯) = 餘蓋遞餘鏇壓簾壓壓築 窪醖艱餘構艱醖獵醖鏇 (顧鬱膚齋鏇壓觸鹽積淵, 壓繭蓋範鑰廠齋鹹遞遞 ~ 遞構窪憲鏇齋簾遞顧鬱) 更多 | ||||||
临床1期 | 24 | 鹽構艱簾夢憲蓋選壓窪(餘壓餘鏇積選願襯醖壓) = There were no serious adverse events 膚願膚艱衊糧鏇範齋廠 (壓鏇淵顧觸築獵觸鹽齋 ) 更多 | 积极 | 2018-03-21 | |||
Placebo |
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