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Catabasis Pharmaceuticals Announces Preliminary Phase 1 Data for Hypercholesterolemia Product Candidate CAT-2054Catabasis Pharmaceuticals, Inc., a clinical-stage drug development company built on a pathway pharmacology technology platform, today 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 hypercholesterolemia. 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 randomized 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-204 and placebo. All reported AEs were mild. In the ongoing multiple ascending dose portion of the Phase 1 trial, 40 healthy volunteers have been randomized 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. About CAT-2054 CAT-2054 is an investigational oral drug initially being developed for the treatment of hypercholesterolemia in patients for whom existing therapies are insufficient. By modulating the SREBP pathway, CAT-2054 may inhibit production of important cholesterol metabolism proteins such as PCSK9, HMG-CoA reductase, ATP (News - Alert) citrate lyase and NPC1L1. If approved, CAT-2054, may have the potential to be the first therapy to simultaneously modulate cholesterol synthesis, clearance and absorption. About Catabasis Catabasis Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics using its proprietary Safely Metabolized And Rationally Targeted, or SMART, linker technology platform. The Company's SMART linker technology platform is based on the concept of treating diseases by simultaneously modulating multiple targets in one or more related disease pathways. The Company engineers bi-functional product candidates that are conjugates of two molecules, or bioactives, each with known pharmacological activity, joined by one of its proprietary SMART linkers. The SMART linker conjugates are designed for enhanced efficacy and improved safety and tolerability. The Company's focus is on treatments for rare diseases. The Company is also developing other product candidates for the treatment of serious lipid disorders. For more information on the Company's technology and pipeline of drug candidates, please visit www.catabasis.com.
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