Catabasis Pharmaceuticals has announced preliminary Phase 1 clinical trial data for CAT-2054, the Company’s product candidate targeting the Sterol Regulatory Element-Binding Protein, or SREBP, pathway for the potential treatment of hypercholesterolaemia.
In January 2015, the Company initiated a Phase 1 clinical trial to assess the safety, tolerability and pharmacokinetics of CAT-2054 in healthy volunteers. Preliminary data are available for the full range of doses tested in the single and multiple ascending dose portions of the Phase 1 trial. Catabasis expects that full results will be available in the third quarter of 2015.
In the single ascending dose portion of the Phase 1 clinical trial, 38 healthy volunteers were randomised to receive CAT-2054 in capsules at doses ranging from 50 mg to 1000 mg or placebo. When single doses of CAT-2054 were administered under fed and fasted conditions, CAT-2054 was well-tolerated and no serious adverse events (AEs) were reported. No safety signals were observed in laboratory vital sign or electrocardiogram results following CAT-2054 administration. The observed AEs occurring under fed and fasted conditions at doses up to 500 mg were similar for CAT-2054 and placebo. All reported AEs were mild.
Statistically significant decreases in median LDL-C levels of up to 20% were observed in the CAT-2054 study
In the ongoing multiple ascending dose portion of the Phase 1 trial, 40 healthy volunteers have been randomised to receive CAT-2054 in soft gelatin capsules at daily doses ranging from 100 mg to 750 mg or placebo for 14 days. In these subjects, CAT-2054 was well-tolerated and no serious AEs were reported. No safety signals were observed in laboratory vital signs or electrocardiogram results following CAT-2054 administration and all subjects completed dosing. All reported AEs were mild.
Lipid biomarkers also were measured in the healthy volunteers enrolled in the Phase 1 trial. Decreases in LDL-C were observed at the end of the 14-day dosing period at doses of 500 and 750 mg. Decreases in median LDL-C levels of up to 20% were observed at day 21 which were statistically significant compared to baseline for all dose levels.
