Phase I extension study demonstrates beneficial effects on lipid metabolism with C21
The extension study, initiated in January 2017, was performed on a group of overweight (BMI 30-35 and waist-to-hip ratio (WHR) above 0.9) but otherwise healthy men. In total 16 volunteers participated, whereof 8 were given 100 mg C21 in a once daily dose and 8 were given placebo over a period of 8 days. 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.
As previously communicated, the results from the study verified that C21 was well tolerated and safe also for this group, as there were no serious adverse events. Further and importantly, in-depth analyses of biomarker data revealed beneficial metabolic effects with C21, which is a first demonstration of pharmacodynamic effects in man for C21 and indeed for the pharmacological principle of AT2 receptor stimulation.
C21 demonstrated clinically relevant protective effects on blood lipids as plasma LDL (Low-Density Lipoprotein) lowering and HDL (High-Density Lipoprotein) increase were noted for the C21 group but not the placebo group. The observed changes in LDL and HDL were statistically significant (p<?0.05) in the C21 treated group for a total of 29 individual biomarkers. Importantly, some biomarkers were determined independently by different methods and laboratories. Moreover, the pattern of positively changed biomarkers was highly consistent.
The complete data for the study will be submitted for publication in a peer-reviewed journal.
Alongside safety and tolerability aspects, the purpose of the study was to investigate if pharmacodynamic effects could be demonstrated and whether earlier preclinical studies with C21, where many beneficial effects in models of obesity and compromised metabolism have been published, could be translated into man. It was consequently highly encouraging that C21 proved to demonstrate significant effects also in man.
“Although this was an exploratory study in a small cohort, the consistency of the findings makes us believe that we really see a pharmacodynamic effect of C21, which has a beneficial impact on lipoprotein pattern” says Professor Mika Scheinin, Principle Investigator for the study, CRST and University of Turku, Finland.
“The effects noted in man for such a short study period and with the selected dose are very encouraging for the further clinical development with C21” says Professor Ulrike Muscha Steckelings, CSO at Vicore Pharma.
“The results from the extension of the Phase I study are very reassuring for the upcoming Phase IIa study on IPF which is currently in late planning” says Per Jansson, CEO at Vicore Pharma.
Audiocast/Conference call on October 2 at 14:00 CET
All interested parties are invited to participate in a telephone conference to go through the results from the phase I extension study, which will include a presentation, on the same day (October 2) at 14:00 CET. The event will be hosted by Vicore Pharma’s CEO, Per Jansson, and CSO Ulrike Muscha Steckelings. The presentation will be held in English.
Slides used in the presentation will be live on the company’s website during the conference call under Events & Presentations and will be made available after the call as well. To participate in the telephone conference, please call:
UK: +44 203 008 9801
SE: +46 856 642 662
US: +1 855 753 2235
A link to audio cast can be found on the Vicore Pharma website under Events & Presentations or here: https://tv.streamfabriken.com/2017-10-02-vicore-pharma-pressconference
This information is information that Vicore Pharma Holding AB is obliged to make public pursuantto the EU Market Abuse Regulation. The information was submitted for publication through the agency of the contact person set out above, at 08.00 CET on October 2, 2017