Data Presented at ATVB 2013 Scientific Sessions —
LAKE BUENA VISTA, FL, USA I May 2, 2013 I Esperion Therapeutics, Inc., a privately-held clinical-stage biopharmaceutical company focused on developing and commercializing first-in-class, oral low-density lipoprotein cholesterol (LDL-C) lowering therapies for the treatment of hypercholesterolemia and other cardiometabolic disorders, today announced full results of a Phase 2 clinical trial of ETC-1002 in patients with Type 2 diabetes and hypercholesterolemia. The trial met its primary endpoint, demonstrating that ETC-1002 lowered LDL-C by up to 43 percent and was associated with improvements in control of other cardiometabolic risk factors. In addition, ETC-1002 was well tolerated.
The data were presented here in an oral session at the Arteriosclerosis, Thrombosis, and Vascular Biology (ATVB) 2013 Scientific Sessions. Esperion previously announced topline results from this clinical trial in January 2013.
Esperion is currently evaluating ETC-1002 in multiple Phase 2 clinical trials in more targeted patient populations. These include a Phase 2 trial in patients with hypercholesterolemia who are intolerant to statin therapy and a Phase 2 trial of ETC-1002 in combination with statin therapy in patients with hypercholesterolemia.
“We are encouraged by both the significant efficacy observed, as well as the tolerability results in this trial, especially since there were no reported cases of myalgia. Our clinical program is primarily focused on statin intolerant and resistant patients where tolerability of ETC-1002 is an important factor,” said Roger S. Newton, Ph.D., chairman and chief scientific officer of Esperion. “We believe that these results show that ETC-1002 has the potential to be developed in broader patient populations with multiple cardiometabolic risk factors, especially in patients who suffer from both hypercholesterolemia and diabetes.”
Phase 2 Trial Design and Results
This randomized, double-blind, placebo-controlled, parallel group, single-site, Phase 2 trial assessed the LDL-C lowering efficacy and safety of ETC-1002 compared with placebo in patients with Type 2 diabetes. A total of 60 patients with a history of Type 2 diabetes (HbA1C 7-10 percent), a body mass index (BMI) of 25-35 kg/m2, and LDL-C ≥100 mg/dL were randomized to ETC-1002 (80 mg followed by 120 mg) or placebo for four weeks and treated in an inpatient unit where their diet and lifestyle were controlled.
After 2 weeks of treatment with 80 mg of ETC-1002, LDL-C was reduced by an average of 32 percent (p
The most common adverse events in the ETC-1002 treated group (experienced by more than 5 percent of trial participants) were headache, hyperglycemia, constipation, arthralgia, dry eye and viral upper respiratory tract infection. The most common adverse events in the placebo-treated group were headache, hyperglycemia, dry eye, viral upper respiratory tract infection, pruritus, abdominal pain, nausea and dizziness. Importantly, no patients discontinued the trial because of myalgia, hypoglycemia or hypotension.
About Statin Intolerance and ETC-1002
It is estimated that more than 2 million U.S. adults have discontinued statin therapy because of myalgia (muscle pain or weakness). Symptoms of myalgia occur in up to 20 percent of patients on statin therapy in clinical practice.
ETC-1002 is a first-in-class, orally available, once-daily LDL-C lowering small molecule therapy designed to target known lipid and carbohydrate metabolic pathways to lower levels of LDL-C and to avoid many of the side effects associated with existing LDL-C lowering therapies. Phase 2 clinical trials of ETC-1002 conducted to date have demonstrated significant average LDL-C reductions, as well as reductions comparable to statins in levels of hsCRP, a key marker of inflammation associated with cardiovascular disease. In clinical research to date, ETC-1002 has been well tolerated. No serious adverse events have been observed in more than 230 patients treated with ETC-1002.
Unlike some therapies currently in development that, if approved, will require regular injections, ETC-1002 is an oral pill taken once daily, the same way traditional LDL-C lowering therapies are administered. ETC-1002 is targeted for statin-intolerant patients with elevated levels of LDL-C.
About Esperion Therapeutics
Esperion Therapeutics, Inc. is a biopharmaceutical company focused on the research, development and commercialization of therapies for the treatment of patients with elevated levels of low-density lipoprotein cholesterol (LDL-C) and other cardiometabolic risk factors. ETC-1002, Esperion’s lead product candidate, is a novel, first-in-class, orally available, once-daily LDL-C lowering small molecule therapy designed to target known lipid and carbohydrate metabolic pathways to lower levels of LDL-C and to avoid many of the side effects associated with existing LDL-C lowering therapies. ETC-1002 is targeted for statin-intolerant patients with elevated levels of LDL-C. For more information, please visit www.esperion.com.
SOURCE: Esperion Therapeutics
Post Views: 69
Data Presented at ATVB 2013 Scientific Sessions —
LAKE BUENA VISTA, FL, USA I May 2, 2013 I Esperion Therapeutics, Inc., a privately-held clinical-stage biopharmaceutical company focused on developing and commercializing first-in-class, oral low-density lipoprotein cholesterol (LDL-C) lowering therapies for the treatment of hypercholesterolemia and other cardiometabolic disorders, today announced full results of a Phase 2 clinical trial of ETC-1002 in patients with Type 2 diabetes and hypercholesterolemia. The trial met its primary endpoint, demonstrating that ETC-1002 lowered LDL-C by up to 43 percent and was associated with improvements in control of other cardiometabolic risk factors. In addition, ETC-1002 was well tolerated.
The data were presented here in an oral session at the Arteriosclerosis, Thrombosis, and Vascular Biology (ATVB) 2013 Scientific Sessions. Esperion previously announced topline results from this clinical trial in January 2013.
Esperion is currently evaluating ETC-1002 in multiple Phase 2 clinical trials in more targeted patient populations. These include a Phase 2 trial in patients with hypercholesterolemia who are intolerant to statin therapy and a Phase 2 trial of ETC-1002 in combination with statin therapy in patients with hypercholesterolemia.
“We are encouraged by both the significant efficacy observed, as well as the tolerability results in this trial, especially since there were no reported cases of myalgia. Our clinical program is primarily focused on statin intolerant and resistant patients where tolerability of ETC-1002 is an important factor,” said Roger S. Newton, Ph.D., chairman and chief scientific officer of Esperion. “We believe that these results show that ETC-1002 has the potential to be developed in broader patient populations with multiple cardiometabolic risk factors, especially in patients who suffer from both hypercholesterolemia and diabetes.”
Phase 2 Trial Design and Results
This randomized, double-blind, placebo-controlled, parallel group, single-site, Phase 2 trial assessed the LDL-C lowering efficacy and safety of ETC-1002 compared with placebo in patients with Type 2 diabetes. A total of 60 patients with a history of Type 2 diabetes (HbA1C 7-10 percent), a body mass index (BMI) of 25-35 kg/m2, and LDL-C ≥100 mg/dL were randomized to ETC-1002 (80 mg followed by 120 mg) or placebo for four weeks and treated in an inpatient unit where their diet and lifestyle were controlled.
After 2 weeks of treatment with 80 mg of ETC-1002, LDL-C was reduced by an average of 32 percent (p
The most common adverse events in the ETC-1002 treated group (experienced by more than 5 percent of trial participants) were headache, hyperglycemia, constipation, arthralgia, dry eye and viral upper respiratory tract infection. The most common adverse events in the placebo-treated group were headache, hyperglycemia, dry eye, viral upper respiratory tract infection, pruritus, abdominal pain, nausea and dizziness. Importantly, no patients discontinued the trial because of myalgia, hypoglycemia or hypotension.
About Statin Intolerance and ETC-1002
It is estimated that more than 2 million U.S. adults have discontinued statin therapy because of myalgia (muscle pain or weakness). Symptoms of myalgia occur in up to 20 percent of patients on statin therapy in clinical practice.
ETC-1002 is a first-in-class, orally available, once-daily LDL-C lowering small molecule therapy designed to target known lipid and carbohydrate metabolic pathways to lower levels of LDL-C and to avoid many of the side effects associated with existing LDL-C lowering therapies. Phase 2 clinical trials of ETC-1002 conducted to date have demonstrated significant average LDL-C reductions, as well as reductions comparable to statins in levels of hsCRP, a key marker of inflammation associated with cardiovascular disease. In clinical research to date, ETC-1002 has been well tolerated. No serious adverse events have been observed in more than 230 patients treated with ETC-1002.
Unlike some therapies currently in development that, if approved, will require regular injections, ETC-1002 is an oral pill taken once daily, the same way traditional LDL-C lowering therapies are administered. ETC-1002 is targeted for statin-intolerant patients with elevated levels of LDL-C.
About Esperion Therapeutics
Esperion Therapeutics, Inc. is a biopharmaceutical company focused on the research, development and commercialization of therapies for the treatment of patients with elevated levels of low-density lipoprotein cholesterol (LDL-C) and other cardiometabolic risk factors. ETC-1002, Esperion’s lead product candidate, is a novel, first-in-class, orally available, once-daily LDL-C lowering small molecule therapy designed to target known lipid and carbohydrate metabolic pathways to lower levels of LDL-C and to avoid many of the side effects associated with existing LDL-C lowering therapies. ETC-1002 is targeted for statin-intolerant patients with elevated levels of LDL-C. For more information, please visit www.esperion.com.
SOURCE: Esperion Therapeutics
Post Views: 69
