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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 June 19, 2017

Eli Lilly released results from three phase III studies of galcanezumab for the prevention of episodic and chronic migraine. In the EVOLVE-1 and EVOLVE-2 studies, over the six-month treatment period, patients with episodic migraine treated with galcanezumab 120mg and 240mg doses experienced a statistically significantly greater decrease in the average number of monthly migraine headache days compared to patients treated with placebo, with statistically significant improvements observed at each month starting at one month of treatment. A statistically significantly greater percentage of patients treated with both doses of galcanezumab achieved at least a 50%, 75% and 100% reduction in the number of migraine headache days compared to placebo over the six-month treatment period, in both studies after multiplicity adjustment. In the REGAIN study, over the three-month treatment period, patients with chronic migraine treated with galcanezumab 120mg and 240mg doses experienced a statistically significantly greater decrease in the average number of monthly migraine headache days compared to patients treated with placebo. Statistically significant improvements for both doses of galcanezumab were observed at each month starting at one month of treatment. A statistically significantly greater percentage of patients also achieved at least a 50% reduction in the number of migraine headache days compared to placebo over the three-month treatment period (27.6% for 120mg and 27.5% for 240mg compared to 15.4% for placebo, p<0.001 for both dosing groups) after multiplicity adjustment. Based on these results, Lilly will submit a Biologics License Application to the FDA for galcanezumab in the second half of 2017, followed by submissions to other regulatory agencies around the world.

Janssen Research & Development issued results from a phase III trial of Simponi Aria (golimumab) in the treatment of active psoriatic arthritis. The GO-VIBRANT trial was a multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of intravenous (IV) golimumab in biologic-naïve adult patients with active psoriatic arthritis. Patients (n=480) were randomized one-to-one to receive Simponi Aria 2mg/kg at weeks zero, four and every eight weeks thereafter or placebo at weeks zero, four, 12 and 20 with crossover to Simponi Aria at week 24. The primary endpoint was American College of Rheumatology (ACR20) response at week 14. Multiplicity-controlled endpoints at week 14 included ACR50, ACR70, PASI 75, change from baseline in HAQ-DI, enthesitis, dactylitis and SF-36 PCS/MCS scores. At week 24, ACR50 and change from baseline in total modified vdH-S (structural damage) score were evaluated. In GO-VIBRANT, 75.1% of patients with active psoriatic arthritis receiving Simponi Aria 2mg/kg achieved at least a 20% improvement in arthritis signs and symptoms as measured by the ACR20 at week 14, the study’s primary endpoint, compared with 21.8% of patients receiving placebo (p<0.001). Simponi Aria also showed significant improvement across all secondary endpoints evaluating improvements in skin symptoms, joint damage and health-related quality of life measures. Simponi Aria is currently under review by the FDA for the treatment of adults with active psoriatic arthritis and the treatment of adults with ankylosing spondylitis. Simponi Aria is approved in the U.S. for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate.

Lexicon Pharmaceuticals reported results of two phase III sotagliflozin studies for type 1 diabetes. Collectively, 24-week data from the two pivotal inTandem1 and inTandem2 studies for sotagliflozin in patients with type 1 diabetes demonstrated the following: Sotagliflozin 200mg and 400mg on top of optimized insulin significantly reduced A1C compared to placebo (p<0.001 in both studies). Sotagliflozin was generally well-tolerated. In both studies, there was a low rate of severe hypoglycemia, which occurred less frequently on sotagliflozin than placebo in three of four arms across the two studies. In both studies, there was a low diabetic ketoacidosis (DKA) rate (0.4% to 3.1% over 24 weeks) that was higher for patients on insulin pump versus multiple dose injections (MDI).

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