A randomized, placebo-controlled study to evaluate the effects of intravenous sevuparin on dermal and systemic LPS responses and the interaction between subcutaneous enoxaparin and sevuparin on coagulation responses in healthy volunteers. - Inhibition of LPS responses by sevuparin

开始日期2021-11-24

申办/合作机构-

ISRCTN32271864

/ Recruiting临床1期IIT

Sevuparin as a potential adjunctive therapy in children with severe malaria: Phase I safety and dose-finding trial

开始日期2021-10-01

申办/合作机构

Imperial College London

100 项与 Sevuparin sodium 相关的临床结果

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100 项与 Sevuparin sodium 相关的转化医学

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100 项与 Sevuparin sodium 相关的专利（医药）

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项与 Sevuparin sodium 相关的文献（医药）

2024-12-01·HemaSphere

Sevuparin strongly reduces hepcidin expression in cells, mice, and healthy human volunteers

Article

作者: Persson, Kristina E. M. ; Gryzik, Magdalena ; Asperti, Michela ; Denardo, Andrea ; Westerberg, Göran ; Öhd, John ; Poli, Maura

Abstract:

Hepcidin is an essential regulator of systemic iron availability mediating both iron uptake from the diet and its release from body stores. Abnormally high hepcidin levels resulting from inflammation in chronic diseases cause iron restriction with the onset of anemia. Restoring physiological levels of hepcidin could contribute to ameliorating anemia in these patients. Heparin derivatives are known to suppress hepcidin expression acting on the BMP/SMAD pathway. The novel heparin derivative sevuparin, modified to markedly reduce its anticoagulant activity, is proposed as a promising hepcidin antagonizing strategy. Sevuparin was tested for its anti‐hepcidin properties in vitro in HepG2 cells, in vivo in mice, and in healthy volunteers. Sevuparin strongly suppressed basal, BMP6‐, and IL6‐dependent hepcidin expression in HepG2 cells in a dose‐ and time‐dependent manner, modulating the essential BMP6/SMAD cascade. These effects were evident in C57BL/6J mice after intravenous injection of a single dose of sevuparin (20 mg/kg) with a 70% reduction of hepcidin mRNA. Remarkably, similar effects were observed in healthy volunteers following single subcutaneous doses at 3, 6, and 9 mg/kg with 40%–50% suppression at 3 and 6 mg/kg and 72% at 9 mg/kg. Moreover, sevuparin was able to reduce hepcidin upregulation in a mouse model of acute inflammation induced by LPS, also showing an amelioration of the inflammatory markers. Combined with its excellent safety profile, these data suggest a role for sevuparin in treating high‐hepcidin disorders.

2021-05-01·Lancet Haematology1区 · 医学

Sevuparin for the treatment of acute pain crisis in patients with sickle cell disease: a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial

1区 · 医学

Article

作者: John Ohd ; Marvin Reid ; Lisa Kirven-Dawes ; Gabriel Ukala ; Bart J Biemond ; Murtadha Al-Khabori ; Erfan Nur ; Jan Kowalski ; Yurdanur Kilinc ; Anil Tombak ; Miguel Abboud ; Hugh Wong ; Curis Yeates ; Yasser Wali ; Alibülent Antmen ; Abdulrahman Al Sultan ; Anita W. Rijneveld ; Ellen Donnelly ; Mohammed Nafea ; Jens Kristensen ; Adlette Inati

BACKGROUND:

There are no approved treatments for vaso-occlusive crises in sickle cell disease. Sevuparin is a novel non-anticoagulant low molecular weight heparinoid, with anti-adhesive properties. In this study, we tested whether sevuparin could shorten vaso-occlusive crisis duration in hospitalised patients with sickle cell disease.

METHODS:

We did a multicentre, double-blinded, placebo-controlled, phase 2 study in 16 public access clinical hospitals in the Netherlands, Lebanon, Turkey, Bahrain, Oman, Saudi Arabia, and Jamaica. Patients aged 12-50 years with a diagnosis of sickle cell disease (types HbSS, HbSC, HbSβ⁰-thalassaemia, or HbSβ⁺-thalassaemia) on a stable dose of hydroxyurea, hospitalised with vaso-occlusive crisis for parenteral opioid analgesia with a projected stay of more than 48 h were included in the study. Patients were randomly assigned (1:1) using a computer-generated randomisation scheme to receive sevuparin (18 mg/kg per day) or placebo (NaCl, 0·9% solution) intravenously for 2-7 days until vaso-occlusive crisis resolution. All individuals involved in the trial were masked to treatment allocation. The analysis was done in the intention-to-treat population. The primary endpoint was time to vaso-occlusive crisis resolution defined as freedom from parenteral opioid use (in preceding 6-10 h); and readiness for discharge as judged by the patient or physician. The trial is registered with ClinicalTrials.gov, NCT02515838.

FINDINGS:

Between Oct 7, 2015, and Feb 10, 2019, 144 patients were randomly assigned and administered sevuparin (n=69) or placebo (n=75). The median age was 22·2 years (range 12·2-33·6), 104 (72%) 144 were adults (18 years or older), and 90 (63%) were male and 54 (37%) were female. The intention-to-treat analysis for the primary endpoint showed no significant difference in median time to vaso-occlusive crisis resolution between the sevuparin and placebo groups (100·4 h [95% CI 85·5-116·8]) vs 86·4 h [70·6-95·1]; hazard ratio 0·89 [0·6-1·3]; p=0·55). Serious adverse events occurred in 16 (22%) of 68 patients in the sevuparin group and in 21 (22%) of patients in the placebo group. The most frequent treatment-emergent adverse events were pyrexia (17 [25%] in the sevuparin group vs 17 [22%] in the placebo group), constipation (12 [18%] vs 17 [22%]), and decreased haemoglobin (18 [26%] vs 9 [12%]). There were no deaths in the sevuparin group and there was one (1%) death in the placebo group after a hyper-haemolytic episode due to alloimmunisation.

INTERPRETATION:

This result, as well as the results seen in other clinical studies of inhibitors of adhesion in sickle cell disease, suggest that selectin-mediated adhesion might be important in the initiation, but not maintenance of vaso-occlusion, indicating that strategies to treat vaso-occlusive crises differ from strategies to prevent this complication.

FUNDING:

Modus Therapeutics.

2021-05-01·Lancet Haematology1区 · 医学

Sevuparin trial for acute pain in sickle cell disease: the dog that did not bark

1区 · 医学

Article

作者: Ellsworth, Patrick ; Little, Jane A

项与 Sevuparin sodium 相关的新闻（医药）

2025-04-02

·modustx.com

Modus Therapeutics opens second study site in ongoing Phase IIa CKD-anemia study

STOCKHOLM, SWEDEN – April 2, 2025: Modus Therapeutics Holding AB (“Modus”), a company developing innovative treatments for patients with significant unmet medical needs, today announced the opening of a second study site in its ongoing Phase IIa clinical study evaluating sevuparin for the treatment of anemia in patients with chronic kidney disease (CKD). The new site is located at the Unità di Nefrologia e Dialisi, Istituti Clinici Scientifici Maugeri S.p.A., in Pavia, Italy. The study’s first study site, Centro Ricerche Cliniche di Verona/Policlinico G.B. Rossi, was initiated at study start in Verona in December 2024. The Phase IIa study is designed to assess the safety, tolerability, and preliminary clinical effects of sevuparin in non-dialysis and dialysis CKD patients with anemia. Opening a second site marks an important milestone in enabling continued efficient patient recruitment and keeping the study on track. "With two active sites now open in Italy, we are well positioned to advance the first part of the study as planned. It is truly a privilege to work alongside the expert teams at these two renowned Italian clinics, and our partner CRO Latis S.r.l." said John Öhd, CEO of Modus Therapeutics, and continues, " There remains a significant unmet medical need in CKD with anemia, and we are committed to developing sevuparin as a new treatment option for these patients." Further study updates are expected in the first half of 2025. For more information on Modus Therapeutics, please contact: John Öhd, CEO, Modus Therapeutics Phone: +46 (0) 70 766 80 97 Email: john.ohd@modustx.com Certified Adviser Svensk Kapitalmarknadsgranskning AB Website: www.skmg.se About Modus Therapeutics and sevuparin Modus is a Swedish biotechnology company that is developing its proprietary polysaccharide sevuparin as a potential treatment for several major healthcare needs including sepsis, endotoxemia, severe malaria and other disorders with severe systemic inflammation as well as states of anemia, related to chronic inflammation such as kidney disease. There is a great need for new treatments that can effectively treat these conditions. Modus’ ambition is to create a paradigm shift in the care of these diseases, where sevuparin could provide therapeutic benefits. Modus Therapeutics is listed on the Nasdaq First North Growth market (“MODTX”). More information is available at www.modustx.com. Sevuparin is a clinical stage, innovative proprietary polysaccharide drug with a multimodal mechanism of action, including immunomodulating, anti-adhesive and anti-aggregate effects. Sevuparin is a heparinoid with markedly attenuated anti-coagulation features that allows severalfold higher doses to be given, compared to regular heparinoids, without the associated risk for bleeding side-effects. Two routes of administration of sevuparin are currently being tested – an IV formulation for in-patient administration and a subcutaneous formulation that allows ambulatory and home care administration. Attachments Modus Therapeutics opens second study site in ongoing Phase IIa CKD-anemia study

临床2期

2025-03-31

·modustx.com

Modus Therapeutics Secures Bridge Financing from Karolinska Development

STOCKHOLM, SWEDEN – March 31 2025: Modus Therapeutics Holding AB (“Modus”) today announces that the company has secured access to bridge financing of up to SEK 5.0 million from its largest shareholder, Karolinska Development AB. The financing enables Modus to maintain strong operational momentum in its ongoing Phase IIa study targeting anemia in chronic kidney disease (CKD). John Öhd, CEO of Modus Therapeutics, commented: “We are grateful for the continued support from our long-term investor Karolinska Development. This bridge financing is an important step in ensuring the progress of our clinical program, with current focus on completing Part 1 of our Phase IIa CKD study and preparing for Part 2. In parallel, we continue to actively evaluate options for long-term financing.” For more information on Modus Therapeutics, please contact: John Öhd, CEO, Modus Therapeutics Phone: +46 (0) 70 766 80 97 Email: john.ohd@modustx.com This information is information that Modus Therapeutics Holding AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2025-03-31 14:00 CEST. Certified Adviser Svensk Kapitalmarknadsgranskning AB Website: www.skmg.se About Modus Therapeutics and sevuparin Modus is a Swedish biotechnology company that is developing its proprietary polysaccharide sevuparin as a potential treatment for several major healthcare needs including sepsis, endotoxemia, severe malaria and other disorders with severe systemic inflammation as well as states of anemia, related to chronic inflammation such as kidney disease. There is a great need for new treatments that can effectively treat these conditions. Modus’ ambition is to create a paradigm shift in the care of these diseases, where sevuparin could provide therapeutic benefits. Modus Therapeutics is listed on the Nasdaq First North Growth market (“MODTX”). More information is available at www.modustx.com. Sevuparin is a clinical stage, innovative proprietary polysaccharide drug with a multimodal mechanism of action, including immunomodulating, anti-adhesive and anti-aggregate effects. Sevuparin is a heparinoid with markedly attenuated anti-coagulation features that allows severalfold higher doses to be given, compared to regular heparinoids, without the associated risk for bleeding side-effects. Two routes of administration of sevuparin are currently being tested – an IV formulation for in-patient administration and a subcutaneous formulation that allows ambulatory and home care administration. Attachments Modus Therapeutics Secures Bridge Financing from Karolinska Development

临床2期

2025-02-20

·modustx.com

Modus Therapeutics publishes year-end report for 2024

STOCKHOLM, SWEDEN - 20 February 2025: Modus Therapeutics Holding AB (”Modus Therapeutics”) hereby publishes the year-end report for 2024. The report is available as an attached document and on the company's website (www.modustx.com). Below is a summary of the interim report. John Öhd, Modus Therapeutics' CEO, commented:”2024 has been a transformational year for Modus Therapeutics, marked by groundbreaking clinical progress and a reinforced pipeline. With a clear vision and strong scientific foundations, we are poised to drive innovation in delivering innovative treatments for disorders of high need.” The fourth quarter in figures The loss after tax amounted to TSEK 4 713 (4 069). The loss per share amounted to SEK 0,13 (0,18). The cash flow from current operations was negative in the amount of TSEK 3 619 (3 126). The full year in figures The loss after tax amounted to TSEK 15 545 (17 897). The loss per share amounted to SEK 0,43 (1,01). The cash flow from current operations was negative in the amount of TSEK 14 681 (16 684). Important events during the fourth quarter Modus Therapeutics receives a recruitment update from the collaborative Phase Ib study in severe malaria. Modus Therapeutics Receives Approval to Initiate a Phase IIa Clinical Trial for Chronic Kidney Disease (CKD). Modus Therapeutics secures access to bridge financing of 5 MSEK from Karolinska Development. New Article on Sevuparin Published in HemaSphere. Modus Therapeutics Initiates Phase II Study with Sevuparin for the Treatment of Chronic Kidney Disease with Anemia. Modus Therapeutics presents LPS Study Data at Pharmacology 2024. Important events after the end of the period Modus Therapeutics receives a recruitment update from the collaborative Phase Ib study in severe malaria. CEO John Öhd will provide comments on the report in an interview with Jonathan Furelid on February 20 at 11:00. Link to Interview: https://www.youtube.com/watch?v=mZnLJkp0phc For more information on Modus Therapeutics, please contact: John Öhd, CEO, Modus Therapeutics Phone: +46 (0) 70 766 80 97 Email: john.ohd@modustx.com This information is information that Modus Therapeutics Holding AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2025-02-20 08:00 CET. Certified Adviser Svensk Kapitalmarknadsgranskning AB Website: www.skmg.se About Modus Therapeutics and sevuparin Modus is a Swedish biotechnology company that is developing its proprietary polysaccharide sevuparin as a potential treatment for several major healthcare needs including sepsis, endotoxemia, severe malaria and other disorders with severe systemic inflammation as well as states of anemia, related to chronic inflammation such as kidney disease. There is a great need for new treatments that can effectively treat these conditions. Modus’ ambition is to create a paradigm shift in the care of these diseases, where sevuparin could provide therapeutic benefits. Modus Therapeutics is listed on the Nasdaq First North Growth market (“MODTX”). More information is available at www.modustx.com. Sevuparin is a clinical stage, innovative proprietary polysaccharide drug with a multimodal mechanism of action, including immunomodulating, anti-adhesive and anti-aggregate effects. Sevuparin is a heparinoid with markedly attenuated anti-coagulation features that allows severalfold higher doses to be given, compared to regular heparinoids, without the associated risk for bleeding side-effects. Two routes of administration of sevuparin are currently being tested – an IV formulation for in-patient administration and a subcutaneous formulation that allows ambulatory and home care administration. Attachments Modus Year End Report 2024

临床2期临床1期财报

100 项与 Sevuparin sodium 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
慢性肾衰竭贫血	临床2期	意大利	Modus Therapeutics AB	2024-12-02
半规管裂综合征	临床2期	巴林	Modus Therapeutics AB	2015-07-01
半规管裂综合征	临床2期	牙买加	Modus Therapeutics AB	2015-07-01
半规管裂综合征	临床2期	黎巴嫩	Modus Therapeutics AB	2015-07-01
半规管裂综合征	临床2期	荷兰	Modus Therapeutics AB	2015-07-01
半规管裂综合征	临床2期	阿曼	Modus Therapeutics AB	2015-07-01
半规管裂综合征	临床2期	沙特阿拉伯	Modus Therapeutics AB	2015-07-01
半规管裂综合征	临床2期	土耳其	Modus Therapeutics AB	2015-07-01
镰状细胞血症	临床2期	荷兰	Modus Therapeutics AB	2015-04-15
血管闭塞危机	临床2期	荷兰	Modus Therapeutics AB	2015-04-15

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NEWS	临床2期	伴随慢性肾病的贫血 \| 慢性肾病	-	Sevuparin	齋構構觸夢鹽膚簾繭餘(壓鏇遞繭築繭齋築夢鏇) = with no discontinuations due to adverse events, and no observed clinically significant safety trends. 醖鑰範糧築積積鹽淵鹹 (齋範選廠蓋夢廠膚淵鹽 )	积极	2025-08-01
NCT02515838 (Pubmed \| Lancet Haematol) 人工标引	临床2期	急性疼痛 \| 镰状细胞血症	144	sevuparin	糧鑰膚壓顧製窪顧廠襯(範築築齋壓醖製選窪願) = 構鏇廠繭鹹鹽觸鬱鑰範壓獵糧艱築鏇憲鬱蓋鏇 (憲築壓衊築衊鑰築夢齋, 85.5 ~ 116.8) 更多	不佳	2021-05-01
NCT02515838 (Pubmed \| Lancet Haematol) 人工标引	临床2期	急性疼痛 \| 镰状细胞血症	144	Placebo	糧鑰膚壓顧製窪顧廠襯(範築築齋壓醖製選窪願) = 廠襯範淵鏇鹽鹽鬱簾鑰壓獵糧艱築鏇憲鬱蓋鏇 (憲築壓衊築衊鑰築夢齋, 70.6 ~ 95.1) 更多	不佳	2021-05-01