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news.US-based Catabasis Pharmaceuticals has reported positive top-line Phase I trial data for CAT-2054, the company’s product candidate targeting the Sterol Regulatory Element-Binding Protein (SREBP) pathway to treat hypercholesterolemia.
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In either the single or multiple ascending dose arms of the double-blind, randomized clinical trial, CAT-2054 was well-tolerated with no serious adverse events (AEs) observed.
In the multiple ascending dose trial, a decrease in median LDL-C levels of about 20% was observed at day 21 in healthy volunteers.
Mainly, CAT-2054 was also found to be well-tolerated in combination with atorvastatin, the statin drug most commonly used to treat hypercholesterolemia, and there was no evidence for impact of CAT-2054 on the pharmacokinetics of atorvastatin.
Metabolic & Atherosclerosis Research Center director emeritus Evan Stein said: "CAT-2054 is an oral agent that targets SREBP, a key regulator of lipid metabolism, which may be an effective means to lower LDL-C.
"It also has potential effects on other metabolic parameters such as triglycerides, glucose, and liver fat in patients.
"The Phase 1 data of LDL-C efficacy signal combined with no safety issues support the continued clinical development of CAT-2054."
A total of 118 healthy volunteers were included in the Phase I clinical trial, which was designed to evaluate the safety, tolerability and pharmacokinetics of single and multiple ascending oral doses of CAT-2054.
Catabasis chief executive officer Jill Milne said: "Based on these data, we intend to initiate a Phase IIa trial in patients with hypercholesterolemia in the fourth quarter of 2015."