New data show that RIFAXIMIN-α reduces systemic inflammation in patients with cirrhosis and chronic hepatic encephalopathy

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12 April 2018

CORPORATE MEDIA RELEASE

NEW DATA SHOW THAT RIFAXIMIN-α REDUCES SYSTEMIC INFLAMMATION IN PATIENTS WITH CIRRHOSIS AND CHRONIC HEPATIC ENCEPHALOPATHY[i]

 

AMSTERDAM. The Netherlands, 12 April 2018, 09:05AM CET / 08:05AM BST. Norgine B.V. announced results from the RIFSYS study showing that rifaximin-α reduces systemic inflammation, a known driver of hepatic encephalopathy (HE) and the immune dysfunction and infection susceptibility associated with cirrhosis:

  • Significant (p<0.001) reductions in plasma TNFα occurred to day-90 suggesting an important reduction in systemic inflammation
  • Participants on rifaximin-α- but no placebo normalised their hepatic encephalopathy grade by day 30.

Rifaximin–α has previously been shown to reduce bacterial endotoxaemia and improve survival in patients with cirrhosis and the RIFSYS study showed a trend towards reduction in TLR4 a known immune binding site of bacterial endotoxin.[ii]

The study, RIFSYS is a Norgine funded investigator initiated academic study conducted at King’s College London, UK. Dr Vishal Patel, Senior Clinical Lecturer and Honorary Consultant Hepatologist based at the Institute of Liver Studies and Transplantation, King’s College London, UK led the randomised controlled trial with Dr Debbie Shawcross, Clinician Scientist and Honorary Consultant Hepatologist.

Dr Patel explained: “The rationale for undertaking the study was to better understand the therapeutic targets of action of rifaximin and ultimately delineate more clearly the pathophysiological processes involved in driving and resolving hepatic encephalopathy.”

Norgine currently holds marketing rights for rifaximin–α (XIFAXAN® 550mg known as TARGAXAN® 550mg in the UK and Belgium) in Australia, Belgium, Denmark, Finland, Germany, Luxembourg, Netherlands, New Zealand, Norway, Republic of Ireland, Sweden and United Kingdom.

 

 

 

Notes to Editors:

About Norgine

 

Norgine is a leading European specialist pharmaceutical company with a direct commercial presence in all major European markets. In 2017, Norgine’s total net sales were EUR 345 million, up 17 per cent.

Norgine employs over 1,000 people across its commercial, development and manufacturing operations and manages all aspects of product development, production, marketing, sale and supply.

Norgine specialises in gastroenterology, hepatology, cancer and supportive care.

 

Norgine is headquartered in the Netherlands. Norgine owns a R&D site in Hengoed, Wales and two manufacturing sites in Hengoed, Wales and Dreux, France.

 

For more information, please visit www.norgine.it

In 2012, Norgine established a complementary business Norgine Ventures, supporting innovative healthcare companies through the provision of debt-like financing in Europe and the US. For more information, please visit www.norgineventures.com.

NORGINE and the sail logo are trademarks of the Norgine group of companies.

 

XIFAXAN and TARGAXAN are under license from Alfasigma S.p.A. 
XIFAXAN and TARGAXAN are registered trademarks of the Alfasigma group of companies, licensed to the Norgine group of companies.

 

 

Media Contact

Isabelle Jouin, T: +44 (0)1895 826237

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GL/XIF/0418/0186

 

[i] Patel VC et al. Results of a placebo-controlled double blind randomised trial to investigate the efficacy of rifaximin-alpha versus placebo in improving systemic inflammation in patients with cirrhosis and chronic hepatic encephalopathy (RIFSYS Trial), ILC 2018

[ii] Kalambokis et al Clinical Gastroenterology and Hepatology 2012;10:815–818