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April 25, 2011
Amarin reported results from a phase III trial of AMR-101 for mixed dyslipidemia. This phase III placebo-controlled, randomized, double-blind, 12-week study, ANCHOR, enrolled 702 subjects with high triglyceride levels who were on statin therapy. The subjects received AMR101 2g or 4g or placebo. The primary endpoint was the percentage change in triglyceride level from baseline to week 12. The primary endpoint was achieved at both AMR-101 doses, with median reductions in triglyceride levels of 21.5% and 10.1% for the 4 grams and 2 grams per day dose groups, respectively. These reductions were both statistically significant compared to placebo (p<0.0001 and p≡0.0005, respectively). In addition, LDL-C decreased at both doses within the predefined non-inferiority boundary, with a statistically significant 6.2% decrease in LDL-C from baseline versus placebo at 4 gram dose. The safety profile of AMR101 was similar to placebo and there were no treatment-related serious adverse events.
December 7, 2009
Genfit issued positive results from a phase II trial of GFT505 for the treatment of atherogenic dyslipidemia associated with pre-diabetes and abdominal obesity. This randomized, double-blind, placebo controlled trial, dubbed GFT505-2083, enrolled 97 subjects who received placebo or GFT505 (80mg) administered orally once daily for 28 days. The study took place in France, Romania and Tunisia. Efficacy was assessed by comparing changes in plasma triglycerides and HDL-C (good cholesterol) in the GFT505 treated group versus the placebo treated group. All primary objectives were reached. The therapeutic efficacy of GFT505 was demonstrated with a statistically significant 21% (p≡0.0027) reduction of plasma triglycerides and a 9% (p≡0.003) increase in HDL-C level compared to placebo. GFT505 also showed significant effects on multiple secondary endpoints related to lipid metabolism and inflammation. GFT505 was very well tolerated.
June 22, 2009
Kowa reported results from two phase III trials of pitavastatin for the treatment of dyslipidemia in elderly patients. Data are from a core study and an extension study. The active-controlled core study enrolled subjects 65 years and older with primary hypercholesterolemia or combined dyslipidemia. The subjects received pitavastatin (1 mg, 2 mg and 4 mg) or pravastatin (10 mg, 20 mg and 40 mg). The results of the core study demonstrated that pitavastatin was statistically superior to pravastatin across all three dose comparisons as measured by percent change from baseline in LDL-C (P<.001), and that a higher percentage of patients achieved LDL-C goal with pitavastatin 2 mg and 4 mg than in any other treatment group. All three doses of pitavastatin demonstrated a comparable safety profile to low-dose pravastatin. The extension study was a 60-week, open-label extension to this core study. It was conducted to assess the long-term safety of pitavastatin at the recommended starting dose of 2 mg once daily, and the need for up-titration to 4 mg once daily in consenting completers from the pitavastatin treatment groups of the core study. In addition, results from the extension study showed maintenance of the efficacy and safety of pitavastatin 2 mg and 4 mg through 60 weeks.
May 25, 2009
Isis and Genzyme reported positive results from a phase III trial of mipomersen for the treatment of homozygous familial hypercholesterolemia (hoFH). This randomized, double-blind, placebo-controlled study enrolled 51 subjects, aged 12 and older, across international sites. The subjects were randomized to receive a 200 mg dose of mipomersen or placebo via weekly injections for 26 weeks. The trial met the primary endpoint, with a 25% reduction in LDL cholesterol after 26 weeks of treatment versus 3% for placebo (p<0.001). The three secondary endpoints, a reduction in apolipoprotein B, total cholesterol and non-HDL cholesterol, were also reached with statistical significance over placebo (all p<0.001).
November 24, 2008
Metabolex released positive results from a phase II trial of MBX-8025 for the treatment of dyslipidemia. This randomized, double-blind, placebo-controlled study enrolled 183 overweight or obese patients with high cholesterol and triglycerides, of whom 173 completed the entire eight weeks of treatment. The subjects were placed into six groups and received two different doses of MBX-8025 (50 mg and 100 mg), both alone and in combination with Lipitor (20 mg), placebo and Lipitor only. The group treated with MBX-8025 alone experienced an approximate 30% reduction in triglycerides and 20% drop in LDL cholesterol versus placebo after eight weeks of treatment (p< 0.0001). MBX-8025 also raised HDL cholesterol by approximately 8% (50 mg; p≡0.068) and 12% (100 mg; p ≡0.0045) and selectively and substantially depleted the small, dense LDL cholesterol particles, both alone and in combination with Lipitor. In addition, the groups treated with MBX-8025 experienced decreases in fasting insulin and glucose (100 mg; p≡ 0.01) and significant decreases in the liver enzymes Gamma-glutamyl transferase and alkaline phosphatase. MBX-8025 was well tolerated.
November 17, 2008
Aegerion Pharma reported positive pooled results from three phase II trials of AEGR-733 for the treatment of dyslipidemia. The three trials enrolled more than 460 subjects with dyslipidemia and ranged in duration from 8 to 12 weeks. The subjects received AEGR-733 (2.5 mg to 10 mg) administered alone as a once-daily pill, and also in combination with other lipid lowering agents, including Lipitor, Zetia and fenofibrate. At the higher doses, AEGR-733 reduced LDL-C up to 35% from baseline when used as a monotherapy, and up to 66% from baseline when administered in combination with Lipitor. The subjects also experienced a reduction in their triglyceride levels by up to 50% and weight loss of up to 3% after 12 weeks on therapy. One of the trials was designed to evaluate the hepatic fat levels of subjects treated with AEGR-733 alone and in combination with Lipitor, Zetia and fenofibrate. The average hepatic fat levels after 12 weeks of exposure across doses of AEGR-733 ranging from 2.5 to 10 mg were approximately 7% with no arm exceeding 10%. Treatment was well tolerated. A phase III trial of AEGR-733 is currently underway.
September 10, 2007
Merck announced positive results from a phase III trial of Cordaptive for the treatment of dyslipidemia. This double-blind, randomized trial enrolled 1,613 subjects who received Cordaptive (1 gram/day), extended-release niacin alone (1 gram/day) or placebo. After four weeks, the active treatment groups doubled their respective doses to 2 grams per day for an additional 20 weeks. The co-primary endpoints were the effects of 2 grams of Cordaptive versus placebo on percent changes in LDL-cholesterol (LDL-C) across weeks 12 to 24, and the effects of 1 gram of Cordaptive versus extended-release niacin on flushing symptom severity during the first week of treatment. In the subjects who advanced to 2 grams of Cordaptive, LDL-C levels were reduced from baseline by an average of 19% (versus a reduction of 0.5% with placebo). In addition, in the subjects receiving 1 mg of Cordaptive, 69% reported either no flushing symptoms or mild flushing symptoms during the first week of treatment compared to 44% of those who received extended-release niacin alone. Secondary endpoints included the effects of 2 grams of Cordaptive versus placebo on HDL-cholesterol (HDL- C) levels, triglyceride levels and other lipid parameters, and the flushing frequency and intensity of 2 grams of Cordaptive compared to extended-release niacin alone. In the subjects receiving Cordaptive 2 mg their HDL-C levels increased by an average of 19% (versus a reduction of 1.2% with placebo), and their triglyceride levels were reduced by an average of 22% (versus an increase of 3.6% with placebo). By week 24, the frequency of moderate or greater flushing was 2 days/week for subjects receiving 2 grams of Cordaptive or a placebo versus 7 days/week among those treated with 2 grams of extended-release niacin. A NDA for Cordaptive in the treatment of dyslipidemia is currently under review by the FDA.
Novartis reported positive results from a phase II trial of SPP100 for the treatment of heart failure. This trial, dubbed ALOFT (ALiskiren Observation of Heart Failure Treatment), enrolled 302 subjects who were treated with SPP100 150 mg once per day plus standard heart failure therapy or placebo plus standard therapy. Results revealed that subjects treated with SPP100 plus standard therapy showed significant reductions in B-type natriuretic peptide (BNP) which were nearly five times greater than reductions with standard therapy alone (-61 pg/mL versus -12 pg/mL, p= 0.016). Treatment with SPP100 was safe and well tolerated, with a profile similar to placebo. Based on the results, Novartis plans to proceed with the development of SPP100 into phase III trials.
Sanofi-Aventis issued positive long-term results from two clinical trials of Lovenox for the treatment of acute ST-segment elevation myocardial infarction (STEMI). The first trial, dubbed ExTRACT-TIMI 25 (Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment, Thrombolysis in Myocardial Infarction -- Study 25), enrolled 4,676 subjects. The subjects received adjunctive anticoagulation therapy with either Lovenox or unfractionated heparin (UFH) in a blinded fashion during fibrinolysis and underwent subsequent percutaneous coronary intervention (PCI). Results at one year showed that the primary endpoint of death or nonfatal myocardial infarction remained significantly in favor or Lovenox versus UFH (15.8% versus 17.0%, p-0.01). Net clinical benefit, including all cause of death, nonfatal myocardial infarction and nonfatal disabling stroke, was also significantly in favor of Lovenox when compared to UFH through one year (16.0% versus 17.3%, p=0.007). The second trial, dubbed STEEPLE (Safety and Efficacy of Enoxaparin in Percutaneous Coronary Intervention (PCI): An International Randomized Evaluation), enrolled 3,528 subjects. The trial was designed to evaluate a single intravenous dose of Lovenox (0.5 mg/kg and 0.75 mg/kg) versus Activated Clotting Time (ACT)-adjusted intravenous UFH in subjects undergoing non-emergency PCI. The primary endpoint was the incidence of major and minor bleeding. Results at one year showed that the composite of all cause death at 1 year and major bleeding was 3.1% for Lovenox 0.5 mg/kg (p=0.06 vs. UFH), 3.4% for Lovenox 0.75 mg/kg (p=0.07 vs. UFH), 3.3% for the two Lovenox arms combined (p=0.03 vs. UFH) and 4.7% for UFH. Lovenox has been approved for the treatment of acute coronary syndromes.