Amgen announced new data that show Repatha, or evolocumab, significantly reduced low-density lipoprotein cholesterol and non-high density lipoprotein cholesterol in patients with Type 2 diabetes and hypercholesterolemia or mixed dyslipidemia, taking the maximum tolerated dose of moderate/high-intensity statin therapy. BANTING was a dedicated study evaluating the efficacy of Repatha, in lowering LDL-C and improving other lipid levels in patients with Type 2 diabetes. In addition to meeting criteria for hypercholesterolemia or mixed dyslipidemia, patients in the trial had varying degrees of glycemic control. Data were presented at the American Diabetes Association 78th Annual Scientific Sessions. Results from the BANTING study show that in patients with Type 2 diabetes and hypercholesterolemia or mixed dyslipidemia, the addition of Repatha to background statin therapy resulted in significant reductions in LDL-C levels. Type 2 diabetes is often associated with dyslipidemia, a condition characterized by low "good" cholesterol or HDL-C and elevated "bad" cholesterol or LDL-C. In addition to producing significant reductions in LDL-C levels, the addition of Repatha to background statin therapy enabled most patients to reach LDL-C levels recommended by current guidelines. The majority of patients in the Repatha group reached LDL-C levels of less than70 mg/dL as recommended by the American College of Clinical Endocrinologists for patients with Type 2 diabetes and one or more risk factors. Treatment with Repatha was also associated with a significantly higher percentage of patients achieving the greater than or equal to 50% reduction in LDL-C levels recommended by the American College of Cardiology and the American Heart Association. Repatha also reduced several other lipid parameters, including non-HDL-C. These results are consistent with results from previous Phase 3 studies demonstrating Repatha's efficacy in reducing LDL-C and non-HDL-C levels in patients with Type 2 diabetes independent of glycemia, insulin use, renal function and cardiovascular disease status at baseline. The safety profile in BANTING was consistent with the established safety profile of Repatha.

Two investigational doses of Lilly's dulaglutide - 4.5 mg and 3.0 mg -, as well as Trulicity 1.5 mg, provided significantly better blood sugar control with weight benefits compared to placebo in adults with type 2 diabetes. Trulicity is Eli Lilly's once-weekly, injectable glucagon-like peptide-1 receptor agonist approved to improve blood sugar in adults with type 2 diabetes. At the study's primary endpoint of 18 weeks, the investigational dulaglutide 4.5 mg and 3.0 mg doses, as well as the currently approved Trulicity 1.5 mg dose, led to superior A1C reductions from baseline in people with type 2 diabetes who remained on treatment throughout the study compared to placebo. The investigational dulaglutide doses also led to significant weight loss compared to placebo, as did Trulicity 1.5 mg. The most commonly reported side effects were gastrointestinal-related and consistent with the GLP-1 RA class. These events included nausea. Trulicity 1.5 mg had a similar side effect profile to previous studies. No participants in any of the treatment groups experienced severe hypoglycemia. The safety and efficacy of the dulaglutide investigational doses are being studied further in a large, Phase 3 clinical trial, AWARD-11. The study is expected to complete in 2019.

Ironwood Pharmaceuticals presented additional data from an exploratory Phase IIa study of praliciguat in patients with type 2 diabetes and hypertension during an oral session at the American Diabetes Association's 78th Scientific Sessions in Orlando, Florida. Praliciguat is an oral, once-daily soluble guanylate cyclase stimulator that is currently being studied in Phase II clinical trials in patients with diabetic nephropathy and in patients with heart failure with preserved ejection fraction. Building on previously announced top-line data from the Phase IIa randomized, placebo-controlled, 14-day study, which showed that treatment with praliciguat led to reductions in blood pressure, fasting plasma glucose, cholesterol levels and triglycerides in patients on a stable regimen of medicines to manage their disease, the newly reported findings also suggested that praliciguat improved insulin sensitivity. Insulin resistance is a hallmark of diabetes and often linked to hypertension. In addition, the data suggested that praliciguat decreased levels of apolipoprotein B, a key lipid parameter that - when elevated - is associated with increased cardiac events. The effect of praliciguat on ApoB in this Phase IIa study was shown within the context of broader lipid effects, including a reduction in total cholesterol and low-density lipoprotein cholesterol, the component of total cholesterol associated with long-term cardiovascular risk. The study was not designed or powered to assess efficacy, but the data yielded clear and consistent trends indicating a positive effect of praliciguat on blood pressure, metabolic parameters and endothelial function biomarkers. These improvements were seen in patients who were taking a stable regimen of therapies to manage their disease; all participating patients were taking at least one medication to manage their hypertension and at least one medication to manage their diabetes, and a majority were also taking additional medications to manage their cholesterol and serum lipid levels. The study also confirmed a pharmacokinetic profile of praliciguat supporting once-daily dosing and suggested broad distribution to relevant tissues, offering the potential to maximize anti-inflammatory, anti-fibrotic and metabolic effects. Praliciguat was generally well-tolerated. Nausea was the only adverse event present in the praliciguat group at a greater incidence rate than placebo. There was a single serious AE, an upper gastrointestinal hemorrhage in a participant with erosive esophagitis receiving praliciguat. Across all five clinical studies of praliciguat to date, praliciguat was found not to impair platelet function or blood clotting, either on its own or when co-administered with aspirin. No other serious bleeding episodes have been observed. All other AEs in this Phase IIa study were characterized as mild.

Array BioPharma announced updated safety and efficacy results, including OS, from the safety lead-in of the Phase 3 BEACON CRC trial evaluating the triplet combination of encorafenib, a BRAF inhibitor, binimetinib, a MEK inhibitor and cetuximab, an anti-EGFR antibody, in patients with BRAFV600E-mutant metastatic colorectal cancer. The results showed that, at the time of analysis, the OS data were fully mature through 12.6 months and that the median OS had not yet been reached. The one-year overall survival rate for this cohort was 62%. These data were presented in an oral presentation at the ESMO 20th World Congress on Gastrointestinal Cancer in Barcelona, Spain. The median progression-free survival for patients treated with the triplet was 8 months and is similar between patients receiving one prior line of therapy and patients receiving two prior lines of therapy. The confirmed overall response rate was 48% and among the 17 patients who received only one prior line of therapy the ORR was 62%. The triple combination was generally well-tolerated with no unexpected toxicities. The most common grade 3 or 4 adverse events seen in at least 10% of patients were fatigue, anemia, increased blood creatine kinase and increased aspartate aminotransferase. The presentation also referenced updated, mature Phase 2 results for the doublet of encorafenib and cetuximab that showed a mOS of 9.3 months, mPFS of 4.2 months and an ORR of 24%. The data cutoff for that analysis was January 2018 with the last patient enrolled in April of 2015. Enrollment in the randomized portion of the BEACON CRC trial is ongoing.