The extension study, initiated in January 2017, was performed on a group of overweight men (BMI 30-35) and with a hip to waist ratio below 0.9 but otherwise healthy. In total 16 volunteers, whereof 8 were given 100 mg C21 and 8 were given placebo during a period of 8 days participated. The aim of the study was to evaluate safety and tolerability of C21 in a group with a potentially compromised metabolic situation and to investigate if markers of metabolic dysfunction could be affected by C21 during the short treatment period.
The results from the study verified that C21 is well tolerated and safe also in this group as there were no serious adverse effects noted or adverse readings from the laboratory analyses for a large number of biomarkers. In addition, the group receiving C21 demonstrated a tendency to lowering of plasma LDL (low density lipoprotein), the harmful form of cholesterol. Further detailed analysis are still ongoing.
“In view of the small size of the study one should be careful to draw far-reaching conclusions but it is encouraging that we with the support of the study results can formulate a hypothesis that C21 can have positive effects on lipid metabolism” says Professor Mika Scheinin, Principle Investigator for the study, University of Turku, Finland.
The outcome adds to the safety profile of C21 and is important for upcoming Phase IIa study where C21 will be tested on patients suffering from Idiopathic pulmonary fibrosis (IPF).
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This is information which Vicore Pharma Holding AB is required to disclose under the EU Market Abuse Regulation and the Securities Market Act. The information was provided by the above contact person's auspices, for publication August 17, 2017 at. 08:50 CET.
Vicore Pharma develops drugs that act through the AT2 receptor. The company’s drug candidate C21 aims to improve the treatment of idiopathic pulmonary fibrosis, a rare disease for which C21 has been granted orphan drug designation both in the EU and the US. In addition, C21 is explored pre-clinically in a number of rare diseases where the AT2 receptor plays an important role. Vicore Pharma is based in Astra Zeneca's Bioventurehub in Mölndal. The company's share (VICO) is listed for trading on Nasdaq First North in Stockholm with Erik Penser Bank as Certified Adviser. For more information, see www.vicorepharma.com