排名前五的靶点	数量

5-HT3 receptor(5-羟色胺受体3)	1
GPCR(G蛋白偶联受体)	1
VEGI(肿瘤坏死因子超家族成员15)	1
CD153(肿瘤坏死因子配体超家族成员8)	1

关联

项与 Prometheus Biosciences, Inc 相关的药物

Alosetron Hydrochloride

盐酸阿洛司琼

靶点

5-HT3 receptor

作用机制

5-HT3 receptor拮抗剂

在研机构

Sebela Ireland Ltd. [+1]

原研机构

Prometheus, Inc.

在研适应症

腹泻型肠易激综合征 [+1]

非在研适应症

焦虑症 [+3]

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2000-02

Phosphatidyl choline

靶点-

作用机制

粘蛋白刺激剂

在研机构

Lipid Therapeutics GmbH [+1]

原研机构

Ruprecht-Karls-Universität Heidelberg

在研适应症

溃疡性结肠炎

非在研适应症

腹痛 [+1]

最高研发阶段临床3期

首次获批国家/地区-

首次获批日期-

PRA-023

靶点

VEGI

作用机制

VEGI抑制剂

在研机构

Prometheus Biosciences, Inc [+2]

原研机构

Prometheus Biosciences, Inc

在研适应症

溃疡性结肠炎 [+4]

非在研适应症-

最高研发阶段临床3期

首次获批国家/地区-

首次获批日期-

项与 Prometheus Biosciences, Inc 相关的临床试验

NCT05603182 / Recruiting临床1期

A Phase 1, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetics Study of PRA052 in Healthy Volunteers

This is randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PRA052 in healthy volunteers.

开始日期2022-11-01

申办/合作机构

Prometheus Biosciences, Inc

NCT05354349 / Completed临床1期

A Phase 1, Double-Blind, Placebo-Controlled, Single-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PRA023 in Healthy Caucasian and Japanese Adult Volunteers

This is a randomized double-blind, placebo-controlled, single-dose study to evaluate the safety, tolerability, and pharmacokinetics of PRA023 in healthy Caucasian and Japanese adult volunteers

开始日期2022-04-06

申办/合作机构

Prometheus Biosciences, Inc

[+1]

NCT05270668 / Recruiting临床2期

A Double Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PRA023 in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD)

The purpose of this study is to assess the safety and efficacy of PRA023 in participants with SSc-ILD .

开始日期2022-02-22

申办/合作机构

Prometheus Biosciences, Inc

100 项与 Prometheus Biosciences, Inc 相关的临床结果

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0 项与 Prometheus Biosciences, Inc 相关的专利（医药）

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项与 Prometheus Biosciences, Inc 相关的文献（医药）

2013-05-05·Journal of Pharmaceutical and Biomedical Analysis3区 · 医学

Monitoring of adalimumab and antibodies-to-adalimumab levels in patient serum by the homogeneous mobility shift assay

3区 · 医学

Article

作者: Wang, Shui-Long ; Hauenstein, Scott ; Ohrmund, Linda ; Shringarpure, Reshma ; Salbato, Jared ; Reddy, Rukmini ; McCowen, Kevin ; Shah, Shawn ; Lockton, Steven ; Chuang, Emil ; Singh, Sharat

This report describes the analytical validation and application of the homogeneous mobility shift assay (HMSA) method for the measurement of adalimumab and human antibodies-to-adalimumab (ATA) in serum samples from patients who have lost response to adalimumab treatment. Validation of the ATA- and the adalimumab-HMSA revealed a lower limit of detection to be 0.026 U/mL for ATA and 0.018 μg/mL for adalimumab in serum samples. Intra-assay and inter-assay precision determination yielded a coefficient of variation of less than 15%, and the accuracy of both assays was within 20%. Adalimumab drug tolerance in the ATA-HMSA was up to 20 μg/mL in the test serum. Serum samples from 100 drug-naïve healthy subjects were tested to set-up the cut point of 0.55 U/mL for ATA and 0.68 μg/mL for adalimumab. Analysis of 100 serum samples from patients who were losing response to adalimumab showed that 26% had an adalimumab level below the cut point, of these 68% were ATA positive. Overall, 44% of the patients (44/100) were positive for ATA. This study presents evidence that drug and anti-drug antibody levels are important determinants of patient response to therapy.

2012-08-31·Journal of Immunological Methods4区 · 医学

Development and validation of a homogeneous mobility shift assay for the measurement of infliximab and antibodies-to-infliximab levels in patient serum

4区 · 医学

Article

作者: Wang, Shui-Long ; Ohrmund, Linda ; Hauenstein, Scott ; Salbato, Jared ; Reddy, Rukmini ; Monk, Patrick ; Lockton, Steven ; Ling, Nicholas ; Singh, Sharat

Antibody-based drugs such as infliximab (IFX) are effective for the treatment of inflammatory bowel disease (IBD) and other immune-mediated disorders. The development of antibodies against these drugs may result in unfavorable consequences, including the loss of drug efficacy, hypersensitivity reactions, and other adverse events. Therefore, accurate monitoring of serum drug and anti-drug antibody levels should be an important part of therapy for patients being treated with an antibody-based drug. Current methods for the assessment of anti-drug antibodies and drug levels, involving various bridging ELISA and radioimmunoassay techniques, are limited by their sensitivity, interference, and/or complexity. To overcome these limitations, we have developed a non-radiolabeled homogeneous mobility shift assay (HMSA) to measure the antibodies-to-infliximab (ATI) and IFX levels in serum samples. Full method validation was performed on both the ATI- and IFX-HMSA, and the clinical sample test results were also compared with those obtained from a bridging ELISA method to evaluate the difference in performance between the two assays. Validation of the ATI-HMSA revealed a lower limit of quantitation of 0.012 μg/mL in serum. The linear range of quantitation was 0.029-0.54 μg/mL. The intra- and inter-assay precision was less than 20% of coefficient of variation (CV), and the accuracy (% error) of the assay was less than 20%. In serum samples, ATI as low as 0.036 μg/mL can be measured, even in the presence of 60 μg/mL of IFX in the serum. Sera from 100 healthy subjects were tested to determine the cut point of the assay. ATI-positive samples that had been previously analyzed by using a bridging ELISA from 100 patients were also measured by the new method. There was a high correlation between the two methods for ATI levels (p<0.001). Significantly, the new method identified five false-positive samples from the bridging ELISA method. Validation of the mobility shift IFX assay also showed high assay sensitivity, precision and accuracy. The HMSA method may also be applied to other protein-based drugs to accurately detect serum drug and anti-drug antibody levels.

2012-03-01·Current Medical Research and Opinion4区 · 医学

Evaluation of treatment continuation with alosetron by IBS-D severity criteria

4区 · 医学

Article

作者: Nicandro, Jean Paul ; Shin, Paul ; Chuang, Emil

OBJECTIVES:

This article evaluates the characteristics and treatment patterns of female patients with severe diarrhea-predominant irritable bowel syndrome (IBS-D) who were treated with alosetron under a risk management program.

METHODS:

Patients prescribed alosetron (2002-2009) and who voluntarily enrolled in the follow-up study were evaluated. Questionnaires were administered at baseline, Wk 5, Wk 10, and quarterly thereafter for ≤1 year. Subgroup analyses were conducted in female patients with IBS-D ≥6 months, stratified by IBS-D severity criteria met (1-3) from the alosetron prescribing information (treatment recommended in female patients meeting ≥1 severity criterion). The voluntary and observational nature of the study are potential limitations, such that eligible patients in the clinical practice setting may have had more severe IBS-D, possibly representing a more motivated and homogeneous subpopulation of patients than the broader IBS-D population.

RESULTS:

A total of 7841 patients enrolled in the study; 92.4% were adult females; 79.4% (n = 6229) met label criteria. Mean follow-up time was ∼10.3 months; 50.3% completed 1 year. Of the 6229 female patients, 76.9% met 3/3 severity criteria; 21.5% met 2/3 severity criteria; 1.4% met 1/3 severity criteria. The most common complaint was restriction of daily activities, followed by accidents/fecal incontinence, and stomach cramps/bloating. One-year treatment continuation was ≥64% across IBS-D severity groups.

CONCLUSIONS:

One-year treatment continuation with alosetron was high, irrespective of the number of IBS-D severity criteria met. Restriction of daily activities was the primary indicator of disease severity. These findings demonstrate that alosetron continues to be safely and effectively used under the risk management program, and appears to provide long-term benefit in appropriate patients with IBS-D.

154

项与 Prometheus Biosciences, Inc 相关的新闻（医药）

2023-10-04

·PRNewswire

Surgical Reality Pioneer, Beyeonics, Unveils New Chairman of the Board

HAIFA, Israel, Oct. 4, 2023 /PRNewswire/ -- Beyeonics Surgical & Beyeonics Vision, pioneering MedTech sister companies in the field of digital surgical platforms for operating rooms, announces the appointment of Mr. Joseph C. Papa as Chairman of the Board of Beyeonics Surgical and as Board Member of Beyeonics Vision. This strategic decision reflects Beyeonics' commitment to spearheading its technological advancements in Ophthalmology and Neurosurgery. Continue Reading Mr. Joseph C. Papa- Chairman of the Board of Beyeonics Surgical and as Board Member of Beyeonics Vision Mr. Papa is renowned for his leadership as former Chairman and CEO of Bausch Health Companies Inc, as well as CEO and Chairman of a wide range of medical device and pharma companies, including Perrigo, Prometheus Biosciences and SparingVision. Joe's track record of bringing innovation to the healthcare market, and his industry familiarity aligns with Beyeonics' mission to empower surgeons through advanced visualization solutions that incorporate AR and data processing. "We are thrilled to welcome Mr. Papa to our Board. His visionary leadership and immense professional experience resonate deeply with our mission and business objectives. With Joe's expertise, we will further elevate our impact on the healthcare landscape and advance innovations by making lasting impacts on surgeons and their patients," states Co-founder and CEO of Beyeonics group of companies, Mr. Ron Schnieder. "Joining Ron and the experienced team at Beyeonics is an exciting opportunity," Mr. Papa shared. "I look forward to our mutual journey, taking the company through its next growth phase and to continue advancing our technology to help physicians improve health care outcomes and efficiency. I have confidence in Beyeonics' value proposition, which holds the potential to significantly transform the fields of Ophthalmology and Neurosurgery." About Beyeonics Beyeonics™ is a group of medical technology companies (Beyeonics Vision and Beyeonics Surgical) that develop and deliver evolving digital surgical platforms to operating rooms across multiple therapeutic areas. Leveraging its aviation technology heritage, the Beyeonics™ platform technology integrates advanced imaging, augmented reality, virtual reality, and data processing capabilities all of which are displayed and controlled by the surgeon via the surgical headset. Beyeonics Vision Ltd. is developing and manufacturing the Beyeonics one™, the first ophthalmic Exoscope that delivers advanced visualization and unconstrained performance to ophthalmic surgeons. Beyeonics Surgical Ltd. is a medical technology company focused on Spine and Neurosurgical platforms, with pipeline applications that include minimally invasive surgery utilizing advanced imaging, VR and AR-based navigation and data processing. For more information visit: Media Contact: Efi Zaritzky VP Marketing [email protected] Photo : Logo : SOURCE Beyeonics

高管变更

2023-10-04

·Firstwordpharma

Sanofi joins anti-TL1A frenzy via partnership with Teva

Sanofi agreed to pay €469 million ($492 million) upfront for rights to co-develop and jointly market Teva’s anti-TL1A candidate TEV-48574 for inflammatory bowel disease (IBD), the companies announced Wednesday. A deal had been expected after sources said in May that Teva was seeking a partner for the experimental drug having previously highlighted it as one of its "key pipeline assets." TEV-48574 is currently in Phase IIb studies for the treatment of ulcerative colitis and Crohn's disease. “Anti-TL1As are a promising class of therapies, and we believe that TEV’574 could emerge as a best-in-class option,” remarked Sanofi CEO Paul Hudson.Under the agreed terms, Sanofi will lead Phase III programme for TEV-48574, with both companies equally sharing the development costs and net profits and losses in major markets, with other markets subject to a royalty arrangement. Along with the upfront payment, Teva is eligible for milestones of up to €940 million ($986 million), with the Israeli drugmaker leading commercialisation in Europe, Israel and specified other countries, while Sanofi will head-up marketing in North America, Japan, other parts of Asia and the rest of the world.Interest in the anti-TL1A class has increased since Merck & Co. agreed in April to put up $10.8 billion to buy Prometheus Biosciences primarily to get its hands on PRA023. Meanwhile, Pfizer and Roivant Sciences are developing a similar drug, dubbed RVT-3101, that is in mid-stage testing.

临床2期引进/卖出临床1期

2023-10-04

·EndPoints

Sanofi's $1.5B pact with Teva in IBD adds fuel to anti-TL1A race against Merck, Roivant and Pfizer

A new player has entered the anti-TL1A race, with Sanofi securing a development and commercialization deal with Teva for its monoclonal antibody under investigation for inflammatory bowel disease. Teva is set to receive €469 million ($500 million) upfront and up to €940 million ($1 billion) in development and launch milestones, the companies revealed early Wednesday morning. In the anti-TL1A contest, Roivant is already in the mix when it teamed up with Pfizer for RVT-3101, as is Merck, which bought Prometheus Biosciences in a deal worth $10.8 billion for MK-7240. You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

并购引进/卖出抗体药物偶联物

100 项与 Prometheus Biosciences, Inc 相关的药物交易

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管线布局

2023年11月29日管线快照

管线布局中药物为当前组织机构及其子机构作为药物机构进行统计，早期临床1期并入临床1期，临床1/2期并入临床2期，临床2/3期并入临床3期

药物发现

临床前

临床1期

临床2期

批准上市

其他

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当前项目

药物(靶点)	适应症	全球最高研发状态

盐酸阿洛司琼 ( 5-HT3 receptor )	腹泻型肠易激综合征更多	批准上市
PRA-023 ( VEGI )	系统性硬化相关的间质性肺病更多	临床2期
T-Cells(Key Biologics)	黑色素瘤更多	临床2期
PRA-052 ( CD153 )	溃疡性结肠炎更多	临床1期
PR1100	免疫系统疾病更多	临床前