Primary Biliary Cirrhosis: Investigating A New Treatment Option using NI 0801, a fully human anti-CXCL10 monoclonal antibody. An open label single arm study to investigate the safety and efficacy of multiple administrations of NI-0801, a fully human anti-CXCL10 monoclonal antibody in primary biliary cirrhosis patients with an incomplete response to ursodeoxycholic acid. - PIANO

开始日期2011-06-21

申办/合作机构-

EUCTR2011-001326-26-GB / Not yet recruitingN/A

PIANO. Primary Biliary Cirrhosis: Investigating A New Treatment Option using NI-0801, a fully human anti-CXCL10 monoclonal antibody.An open label single arm study to investigate the safety and efficacy of multiple administrations of NI-0801, a fully human anti-CXCL10 monoclonal antibody in primary biliary cirrhosis patients with an incomplete response to ursodeoxycholic acid. - PIANO

开始日期2011-05-27

申办/合作机构

Novimmune SA

NL-OMON33532 / CompletedN/A

A randomized, double-blinded, placebo-controlled, single centre, phase I study of the safety of escalating single intravenous doses of NI-0801 in healthy volunteers. - Phase I study to investigate the safety of escalating i.v. doses of Ni-0801

开始日期2008-08-05

申办/合作机构

Novimmune SA

100 项与 NI-0801 相关的临床结果

登录后查看更多信息

100 项与 NI-0801 相关的转化医学

登录后查看更多信息

100 项与 NI-0801 相关的专利（医药）

登录后查看更多信息

项与 NI-0801 相关的文献（医药）

2018-05-01·Hepatology Communications2区 · 医学

NI‐0801, an anti‐chemokine (C‐X‐C motif) ligand 10 antibody, in patients with primary biliary cholangitis and an incomplete response to ursodeoxycholic acid

2区 · 医学

ArticleOA

作者: de Min, Cristina ; Richardson, Paul ; Curbishley, Stuart M. ; Ryder, Stephen D. ; Chapman, Roger W. ; Jones, David E. ; Carbone, Marco ; Guilhot, Florence ; Lapeyre, Geneviève ; Invernizzi, Pietro ; McCune, C. Anne ; de Graaf, Kathy L. ; Floreani, Annarosa ; Moreea, Sulleman ; Adams, David H. ; Ferlin, Walter

NI‐0801 is a fully human monoclonal antibody against chemokine (C‐X‐C motif) ligand 10 (CXCL10), which is involved in the recruitment of inflammatory T cells into the liver. The safety and efficacy of NI‐0801 was assessed in patients with primary biliary cholangitis. In this open‐label phase 2a study, patients with primary biliary cholangitis with an inadequate response to ursodeoxycholic acid received six consecutive intravenous administrations of NI‐0801 (10 mg/kg) every 2 weeks. Patients were followed up for 3 months after the last infusion. Liver function tests, safety assessments, as well as pharmacokinetic and pharmacodynamic parameters were evaluated at different time points throughout the dosing period and the safety follow‐up period. Twenty‐nine patients were enrolled in the study and were treated with NI‐0801. The most frequently reported adverse events included headaches (52%), pruritus (34%), fatigue (24%), and diarrhea (21%). No study drug‐related serious adverse events were reported. NI‐0801 administration did not lead to a significant reduction in any of the liver function tests assessed at the end of the treatment period (i.e., 2 weeks after final NI‐0801 administration) compared to baseline. Conclusion: Despite clear pharmacologic responses in the blood, no therapeutic benefit of multiple administrations of NI‐0801 could be demonstrated. The high production rate of CXCL10 makes it difficult to achieve drug levels that lead to sustained neutralization of the chemokine, thus limiting its targetability. (Hepatology Communications 2018;2:492‐503)

项与 NI-0801 相关的新闻（医药）

2024-04-11

·BioSpace

Edesa Biotech to Participate in Bloom Burton Healthcare Investor Conference

TORONTO, ON / ACCESSWIRE / April 11, 2024 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics for immuno-inflammatory diseases, announced today that the company will participate in the 2024 Bloom Burton & Co. Healthcare Investor Conference scheduled for April 16-17, 2024 in Toronto, Ontario. Edesa's Chief Executive Officer Par Nijhawan, MD, is scheduled to present on Wednesday, April 17 at 11:00 am ET. To meet with Edesa management during the conference, please utilize the conference's online portal or contact the company directly at investors@edesabiotech.com. About Edesa Biotech Edesa Biotech, Inc. (NASDAQ:EDSA) is a clinical-stage biopharmaceutical company developing innovative ways to treat inflammatory and immune-related diseases. The company's most advanced drug candidate is EB05 (paridiprubart), a monoclonal antibody developed for acute and chronic disease indications that involve dysregulated innate immune responses. Edesa is currently evaluating EB05 in a Phase 3 study as a potential treatment for Acute Respiratory Distress Syndrome (ARDS), a life-threatening form of respiratory failure. Edesa is also planning to investigational new drug application for a future Phase 2 study of paridiprubart for pulmonary fibrosis. For its dermatology assets, the company has received regulatory approval to conduct a Phase 2 trial of its EB06 (anti-CXCL10) monoclonal antibody as a treatment for vitiligo, a life-altering autoimmune disease that causes skin to lose its color in patches. In addition, Edesa is developing an sPLA2 inhibitor, EB01 (daniluromer), as a topical treatment for chronic Allergic Contact Dermatitis (ACD), a common occupational skin condition. Sign up for news alerts. Connect with us on X (Twitter) and LinkedIn. Edesa Forward-Looking Statements This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as "anticipate," "believe," "plan," "estimate," "expect," "intend," "may," "will," "would," "could," "should," "might," "potential," or "continue" and variations or similar expressions. Readers should not unduly rely on these forward-looking statements, which are not a guarantee of future performance. There can be no assurance that forward-looking statements will prove to be accurate, as all such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the forward-looking statements. Such risks include: the ability of Edesa to obtain regulatory approval for or successfully commercialize any of its product candidates, the risk that access to sufficient capital to fund Edesa's operations may not be available or may be available on terms that are not commercially favorable to Edesa, the risk that Edesa's product candidates may not be effective against the diseases tested in its clinical trials, the risk that Edesa fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business, Edesa's ability to protect its intellectual property, the timing and success of submission, acceptance and approval of regulatory filings, and the impacts of public health crises. Many of these factors that will determine actual results are beyond the company's ability to control or predict. For a discussion of further risks and uncertainties related to Edesa's business, please refer to Edesa's public company reports filed with the U.S. Securities and Exchange Commission and the British Columbia Securities Commission. All forward-looking statements are made as of the date hereof and are subject to change. Except as required by law, Edesa assumes no obligation to update such statements. CONTACT: Gary Koppenjan Edesa Biotech, Inc. (289) 800-9600 investors@edesabiotech.com SOURCE: Edesa Biotech View the original press release on accesswire.com

临床2期临床3期

2024-03-07

·BioSpace

Edesa Biotech to Participate in Barclays Global Healthcare Conference

TORONTO, ON / ACCESSWIRE / March 7, 2024 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics for immuno-inflammatory diseases, announced today that company management will participate in the Barclays 26th Annual Global Healthcare Conference, which is being held in Miami, Florida, from March 12-14, 2024. Attendees interested in meeting with Edesa can request meetings through conference organizers or by contacting the company at investors@edesabiotech.com. About Edesa Biotech Edesa Biotech, Inc. (Nasdaq:EDSA) is a clinical-stage biopharmaceutical company developing innovative ways to treat inflammatory and immune-related diseases. The company's most advanced drug candidate is EB05 (paridiprubart), a monoclonal antibody developed for acute and chronic disease indications that involve dysregulated innate immune responses. Edesa is currently evaluating EB05 in a Phase 3 study as a potential treatment for Acute Respiratory Distress Syndrome (ARDS), a life-threatening form of respiratory failure. Edesa is also planning to investigational new drug application for a future Phase 2 study of paridiprubart for pulmonary fibrosis. For its dermatology assets, the company has received regulatory approval to conduct a Phase 2 trial of its EB06 (anti-CXCL10) monoclonal antibody as a treatment for vitiligo, a life-altering autoimmune disease that causes skin to lose its color in patches. In addition, Edesa is developing an sPLA2 inhibitor, EB01 (daniluromer), as a topical treatment for chronic Allergic Contact Dermatitis (ACD), a common occupational skin condition. Sign up for news alerts. Connect with us on X (Twitter) and LinkedIn. Edesa Forward-Looking Statements This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as "anticipate," "believe," "plan," "estimate," "expect," "intend," "may," "will," "would," "could," "should," "might," "potential," or "continue" and variations or similar expressions. Readers should not unduly rely on these forward-looking statements, which are not a guarantee of future performance. There can be no assurance that forward-looking statements will prove to be accurate, as all such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the forward-looking statements. Such risks include: the ability of Edesa to obtain regulatory approval for or successfully commercialize any of its product candidates, the risk that access to sufficient capital to fund Edesa's operations may not be available or may be available on terms that are not commercially favorable to Edesa, the risk that Edesa's product candidates may not be effective against the diseases tested in its clinical trials, the risk that Edesa fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business, Edesa's ability to protect its intellectual property, the timing and success of submission, acceptance and approval of regulatory filings, and the impacts of public health crises. Many of these factors that will determine actual results are beyond the company's ability to control or predict. For a discussion of further risks and uncertainties related to Edesa's business, please refer to Edesa's public company reports filed with the U.S. Securities and Exchange Commission and the British Columbia Securities Commission. All forward-looking statements are made as of the date hereof and are subject to change. Except as required by law, Edesa assumes no obligation to update such statements. Contact: Gary Koppenjan Edesa Biotech, Inc. (289) 800-9600 investors@edesabiotech.com SOURCE: Edesa Biotech, Inc. View the original press release on accesswire.com

临床2期临床3期

2024-03-04

·BioSpace

Edesa Biotech to Participate in Upcoming Dermatology Meetings - March 04, 2024

TORONTO, ON / ACCESSWIRE / March 4, 2024 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics for immuno-inflammatory diseases, announced today that the company plans to participate in the American Contact Dermatitis Society Annual Meeting on March 7, 2024 and the American Academy of Dermatology Annual Meeting from March 8-12, 2024 in San Diego, California. Attendees interested in meeting with Edesa can request meetings by contacting the company at investors@edesabiotech.com. About Edesa Biotech Edesa Biotech, Inc. (NASDAQ:EDSA) is a clinical-stage biopharmaceutical company developing innovative ways to treat inflammatory and immune-related diseases. The company's most advanced drug candidate is EB05 (paridiprubart), a monoclonal antibody developed for acute and chronic disease indications that involve dysregulated innate immune responses. Edesa is currently evaluating EB05 in a Phase 3 study as a potential treatment for Acute Respiratory Distress Syndrome (ARDS), a life-threatening form of respiratory failure. Edesa is also planning to investigational new drug application for a future Phase 2 study of paridiprubart for pulmonary fibrosis. For its dermatology assets, the company has received regulatory approval to conduct a Phase 2 trial of its EB06 (anti-CXCL10) monoclonal antibody as a treatment for vitiligo, a life-altering autoimmune disease that causes skin to lose its color in patches. In addition, Edesa is developing an sPLA2 inhibitor, EB01 (daniluromer), as a topical treatment for chronic Allergic Contact Dermatitis (ACD), a common occupational skin condition. Sign up for news alerts. Connect with us on X (Twitter) and LinkedIn. Edesa Forward-Looking Statements This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as "anticipate," "believe," "plan," "estimate," "expect," "intend," "may," "will," "would," "could," "should," "might," "potential," or "continue" and variations or similar expressions. Readers should not unduly rely on these forward-looking statements, which are not a guarantee of future performance. There can be no assurance that forward-looking statements will prove to be accurate, as all such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the forward-looking statements. Such risks include: the ability of Edesa to obtain regulatory approval for or successfully commercialize any of its product candidates, the risk that access to sufficient capital to fund Edesa's operations may not be available or may be available on terms that are not commercially favorable to Edesa, the risk that Edesa's product candidates may not be effective against the diseases tested in its clinical trials, the risk that Edesa fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business, Edesa's ability to protect its intellectual property, the timing and success of submission, acceptance and approval of regulatory filings, and the impacts of public health crises. Many of these factors that will determine actual results are beyond the company's ability to control or predict. For a discussion of further risks and uncertainties related to Edesa's business, please refer to Edesa's public company reports filed with the U.S. Securities and Exchange Commission and the British Columbia Securities Commission. All forward-looking statements are made as of the date hereof and are subject to change. Except as required by law, Edesa assumes no obligation to update such statements. Contact: Gary Koppenjan Edesa Biotech, Inc. (289) 800-9600 investors@edesabiotech.com SOURCE: Edesa Biotech, Inc. View the original press release on accesswire.com

临床2期临床3期

100 项与 NI-0801 相关的药物交易

登录后查看更多信息

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
白癜风	临床2期	加拿大	Edesa Biotech, Inc.	2023-02-01
胆汁性肝硬化	临床2期	瑞士	Berta Holding AG	2022-01-30
胆汁性肝硬化	临床2期	瑞士	Stellar Biotechnologies, Inc.	2022-01-30
原发性胆汁性胆管炎	临床2期	意大利	Novimmune SA	2011-09-08
原发性胆汁性胆管炎	临床2期	英国	Novimmune SA	2011-09-08
刺激性皮炎	临床2期	-	Novimmune SA	2010-11-19
变应性接触性皮炎	临床1期	-	Novimmune SA	2010-11-19

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01430429 (Pubmed \| Hepatol Commun) 人工标引	临床2期	原发性胆汁性胆管炎	29	NI-0801	(鬱願醖鹽鹹繭製蓋繭膚) = headaches (52%), pruritus (34%), fatigue (24%), and diarrhea (21%) 簾艱廠鹹選醖窪鏇獵範 (鏇襯糧繭製獵鏇鏇齋觸 )	不佳	2018-03-23