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New Medical Therapies™

Latest New Medical Therapy Trial Results

Following are the most recent results for new drug therapies currently in clinical trials worldwide. Results are also searchable by therapeutic area beginning with the most recent updates.

Week of September 15, 2014

Eli Lilly issued results of phase III trials of glargine (Lantus) for type 1 diabetes. IMAGINE-1 was a 78-week, open-label study designed to compare BIL (n=295) with insulin glargine (n=160) in combination with mealtime insulin in patients with type 1 diabetes. IMAGINE-3 was a 52-week, double-blind, randomized study designed to compare BIL (n=664) with insulin glargine (n=450) in combination with mealtime insulin in patients with type 1 diabetes. Significantly more patients taking BIL versus those taking insulin glargine achieved an HbA1c of less than 7%. Both trials also showed the rate of nocturnal hypoglycemia was significantly lower in patients taking BIL than in those taking insulin glargine. In both trials there was a statistically significant increase in the rate of total hypoglycemia for patients taking BIL compared with those taking insulin glargine due to a higher rate of daytime hypoglycemic events. In the open-label IMAGINE-1 trial, patients taking BIL reported a statistically significant higher rate of severe hypoglycemic events. However, in the larger, blinded IMAGINE-3 trial the rate of severe hypoglycemic events for treatment with BIL was numerically lower compared with insulin glargine, but was not statistically significant. Lilly is on track to file a submission with regulators by the end of the Q1 2015.

EnteroMedics released results of a pivotal trial of VBLOC Vagal Blocking Therapy for obesity. The study was a prospective, double-blind, sham-controlled clinical trial involving 239 randomized patients (233 implanted) enrolled at 10 sites in the U.S. and Australia. All patients in the trial received an implanted device and were randomized in a 2:1 allocation to VBLOC treatment or sham control groups. VBLOC Therapy-treated patients in the ReCharge Study intention to treat (ITT) group, which included all 239 patients randomized, demonstrated a clinically meaningful excess weight loss (EWL) of 24.4% at 12 months that was statistically significant as compared to the rigorous sham control group. These VBLOC patients also maintained their weight loss with 25% EWL at 18 months and 21% EWL at 24 months. At 12 months, the majority (52.5%) lost 20% or more of their excess weight and nearly one-third of VBLOC Therapy-treated patients lost 30% or more. Statistically significant improvements were observed in the VBLOC Therapy treatment group in total cholesterol, LDL, triglycerides, systolic and diastolic blood pressure, heart rate and waist circumference. The FDA currently is reviewing EnteroMedics’ Premarket Approval (PMA) application for approval of the Maestro Rechargeable System as a treatment for obesity. EnteroMedics anticipates an FDA approval decision in 2014.

Mast Therapeutics reported results from a phase II study of AIR001 (sodium nitrite) inhalation solution for pulmonary arterial hypertension (PAH). The multi-center, open-label, randomized, parallel-dose study randomized subjects into one of three treatment arms and treated with AIR001 for 16 weeks: 80mg once daily after a two-week “run-in” period of 46mg once daily; 46mg four times daily after a two-week run-in period of 46mg four times daily; or 80mg four times daily after a two-week run-in period of 46mg four times daily. The study enrolled 29 patients. All doses showed improvement in median pulmonary vascular resistance (PVR). In the secondary efficacy analysis, all doses showed improvements in the median distances obtained in the six-minute walk test, including clinically meaningful improvements at the highest dose level. AIR001 was well-tolerated, with no treatment-related serious adverse events. In particular, methemoglobin levels remained normal (<1.5%), which distinguishes AIR001 from safety concerns associated with intravenously administered nitrite. AIR001 has been granted Orphan Drug status by the FDA and the EMA for the treatment of PAH. The company will proceed with phase IIa studies and anticipates reporting preliminary study results as early as the second half of 2015.

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