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Successful initiation for FiH Study with VS-01

Last week, VERSANTIS initiated its first clinical study site which will trial VS-01 in patients: Goethe University Hospital Frankfurt. This site was trained on the protocol and is now actively screening to enroll patients!

The team is ready to enter a new era in the life of Versantis
Following recent approvals by both the German regulatory authorities (BfArM) and by the hospital's independent Ethics Committee, VERSANTIS has now initiated a Phase 1b study with VS-01, a lifesaving multi-organ support therapy able to enhance the clearance of ammonia and other toxins from the body. This open-label phase 1b, multi-cohort, single ascending dose and multiple dose study is being conducted at Goethe University Hospital in Frankfurt am Main, Germany, with the primary objective to characterize the safety, tolerability, and pharmacokinetics of VS-01 in patients with decompensated liver cirrhosis and covert hepatic encephalopathy.
Only 4 years after incorporation, this clinical initiation marks a new era for VERSANTIS. The Company expects to complete this Phase 1b study and advance VS-01 to the subsequent Phase 2 trials by spring 2020. 

Patents granted in 2 additional countries.

VERSANTIS recently received the grant approval for two patent applications in South Korea and one in Mexico.
These are additional steps towards global protection of the science and technology behind VS-01.

Recent study reveals the prognostic role of ammonia in cirrhosis.

[Hepatology 2019; Early View]

Shalimar et al (2019) show in acutely decompensated cirrhotic patients that:

  1. Ammonia level correlated with severity of HE;
  2. Ammonia ≥79.5μmol/L yields higher rate of organ failure(s);
  3. Ammonia has been found to be an independent predictor of 28-day mortality.
Ammonia is a potent neurotoxin in patients with liver impairments. VERSANTIS demonstrated in different animal models that VS-01 efficiently and rapidly reduces plasmatic ammonia. In addition, VS-01 also captures toxins associated with other organ failures providing multi-organ support. These biomarkers will be followed in our first-in-human study to reveal the full potential of the therapy.

EINBLICK publishes about Versantis 

The magazine interviewed the management team and features a large piece about VERSANTIS. The Company is presented as a life-saver fighting the global epidemic of liver diseases. An ambitious goal we look forward to realizing. 
>> read the article here.

Food for thought

In the US, mortality due to cirrhosis is expected to triple by 2030. The incidence of cirrhosis itself is up by 60% in the last decade. Against this gloomy backdrop of an unrelenting rise in liver disease, Dr Simon from Harvard Medical School  provides a spark of hope! Her research shows exercise can modify risk factors from liver diseases, as it does for cardiovascular diseases. However, modern societies are governed by desk-jobs and staggeringly sedentary lifestyles; will we be able to avoid and/or cope with this silent liver-disease epidemic?
https://www.sciencedaily.com/releases/2019/05/190519162350.htm.

Outlook

VERSANTIS wishes you an inspiring return from summer break. We will soon be in touch regarding our next milestones: 
  • Closing of a Series B financing Round.
  • Early clinical data with first patients treated with VS-01.
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