CAMBRIDGE, MA, USA I December 9, 2015 I Catabasis Pharmaceuticals, Inc. (NASDAQ: CATB), a clinical-stage drug development company built on a pathway pharmacology technology platform, today announced that the first patient has been dosed in a Phase 2a trial of CAT-2054 for the treatment of hypercholesterolemia. CAT-2054 is an oral small molecule that modulates the SREBP pathway. SREBP is a master regulator of lipid metabolism that impacts LDL, triglycerides and glucose with the potential to impact liver fat and hepatocellular carcinoma.
The CAT-2054 Phase 2a trial is a 4-week randomized, double-blind, placebo-controlled trial in patients with hypercholesterolemia. Catabasis plans to enroll approximately 150 patients that will receive one of four doses of CAT-2054 or placebo, both in addition to a stable dose of a high intensity statin, atorvastatin 40 mg per day. The primary efficacy endpoint for this trial will be percent reduction in LDL cholesterol. Catabasis will also explore the activity of CAT-2054 on other metabolic parameters such as triglycerides and glucose.
“Compared with currently approved cholesterol drugs, CAT-2054 represents a novel pharmacologic approach to treating dyslipidemia,” said Harold Bays, M.D., Medical Director / President of the Louisville Metabolic and Atherosclerosis Research Center Inc. “Based on the encouraging Phase 1 study results, and the continued unmet need in treating patients with abnormal lipid levels, we look forward to participating as a research site in evaluating this agent.”
“CAT-2054, via its modulation of SREBP activity, has the potential to impact LDL cholesterol, triglycerides and glucose metabolism,” said Joanne Donovan, M.D., Ph.D., Chief Medical Officer of Catabasis Pharmaceuticals. “The initiation of the Phase 2a trial is an important milestone in the development of CAT-2054 and signifies that we are one step closer to potentially providing a novel oral treatment option to patients with hypercholesterolemia.”
More information about the CAT-2054 Phase 2a trial can be found on ClinicalTrials.gov under trial identifier NCT02608697.
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 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. Catabasis is currently conducting a Phase 2a trial of CAT-2054 in addition to high intensity statin therapy in patients with hypercholesterolemia. Catabasis has previously reported positive top-line Phase 1 data.
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.
SOURCE: Catabasis Pharmaceuticals
Post Views: 65
CAMBRIDGE, MA, USA I December 9, 2015 I Catabasis Pharmaceuticals, Inc. (NASDAQ: CATB), a clinical-stage drug development company built on a pathway pharmacology technology platform, today announced that the first patient has been dosed in a Phase 2a trial of CAT-2054 for the treatment of hypercholesterolemia. CAT-2054 is an oral small molecule that modulates the SREBP pathway. SREBP is a master regulator of lipid metabolism that impacts LDL, triglycerides and glucose with the potential to impact liver fat and hepatocellular carcinoma.
The CAT-2054 Phase 2a trial is a 4-week randomized, double-blind, placebo-controlled trial in patients with hypercholesterolemia. Catabasis plans to enroll approximately 150 patients that will receive one of four doses of CAT-2054 or placebo, both in addition to a stable dose of a high intensity statin, atorvastatin 40 mg per day. The primary efficacy endpoint for this trial will be percent reduction in LDL cholesterol. Catabasis will also explore the activity of CAT-2054 on other metabolic parameters such as triglycerides and glucose.
“Compared with currently approved cholesterol drugs, CAT-2054 represents a novel pharmacologic approach to treating dyslipidemia,” said Harold Bays, M.D., Medical Director / President of the Louisville Metabolic and Atherosclerosis Research Center Inc. “Based on the encouraging Phase 1 study results, and the continued unmet need in treating patients with abnormal lipid levels, we look forward to participating as a research site in evaluating this agent.”
“CAT-2054, via its modulation of SREBP activity, has the potential to impact LDL cholesterol, triglycerides and glucose metabolism,” said Joanne Donovan, M.D., Ph.D., Chief Medical Officer of Catabasis Pharmaceuticals. “The initiation of the Phase 2a trial is an important milestone in the development of CAT-2054 and signifies that we are one step closer to potentially providing a novel oral treatment option to patients with hypercholesterolemia.”
More information about the CAT-2054 Phase 2a trial can be found on ClinicalTrials.gov under trial identifier NCT02608697.
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 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. Catabasis is currently conducting a Phase 2a trial of CAT-2054 in addition to high intensity statin therapy in patients with hypercholesterolemia. Catabasis has previously reported positive top-line Phase 1 data.
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.
SOURCE: Catabasis Pharmaceuticals
Post Views: 65
