Lipigon Pharmaceuticals AB announced the complete safety results from the lipid lowering investigational ANGPTL4 inhibitory drug Lipisense Phase I trial. Throughout the treatment groups, a favorable safety and pharmacokinetic profile was observed. Analyses also revealed decreasing plasma ANGPTL4 levels with repeated doses in the multiple ascending dose (MAD) groups.

The Phase I study included 54 healthy study participants, and the primary goal was to evaluate safety and tolerability after single och multiple subcutaneous injections of Lipisense at different dose levels or placebo. No serious adverse events have occurred, and adverse events possibly or probably related to treatment were mild resolving injection site reactions (89% of treated, 0% of placebo). In this study there were no signs for elevations of markers of toxicity in liver or kidney.

In the MAD cohorts a dose dependent trend for decreased plasma ANGPTL4 protein levels was detected, clearly suggesting that Lipisense has target engagement. Protein levels in plasma were decreased with up to 24 %, 90 days after last dose, corrected for the placebo effect. Decreasing levels compared to placebo were observed throughout the dosing period.