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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 August 18, 2014

AstraZeneca released results of three phase III trials of lesinurad for the treatment of symptomatic gout (CLEAR1, CLEAR2 and CRYSTAL). CLEAR1 and CLEAR2 were 12-month (U.S. and global, respectively) multicenter, randomized, placebo-controlled studies (n=603 and n=610, respectively) comparing lesinurad (200mg and 400mg once daily) when added to the patient’s current dose of allopurinol (at least 300mg daily, and at least 200mg daily for those with moderate renal impairment) compared to placebo plus allopurinol. CRYSTAL was a 12-month, global, multicenter, randomized, placebo-controlled study (n=324) comparing lesinurad (200mg and 400mg once daily) in combination with febuxostat (80mg) compared to febuxostat (80mg) plus placebo in gout patients with tophi and sUA levels above target. In the CLEAR1 and CLEAR2 trials, patients receiving both lesinurad 200mg and 400mg in combination with allopurinol reached the target sUA goal of <6.0mg/dL at month six compared to allopurinol alone (p<0.0001). In the CRYSTAL trial, patients receiving lesinurad 400mg in combination with febuxostat reached the target sUA goal of <5.0mg/dL at month six compared to febuxostat alone (p<0.0001). Most commonly reported adverse events in CLEAR1 and CLEAR2 were upper respiratory tract infection, nasopharyngitis and back pain. In CRYSTAL, the most commonly reported adverse events were nasopharyngitis, arthralgia and upper respiratory tract infection.

Biodel released phase IIa results comparing BIOD-531 to Humalog Mix 75/25 and Humulin R U-500 in patients with type 2 diabetes with moderate insulin resistance. A single dose of BIOD-531 administered immediately before breakfast achieved significantly lower mean glucose concentrations than Humalog Mix 75/25 administered immediately before breakfast. The mean glucose concentration after breakfast was 167.8 ± 10.4mg/dl with BIOD-531 treatment compared to 205.1 ± 8.3mg/dl with Humalog Mix 75/25 treatment (p<0.001). Premeal BIOD-531 was associated with an average glucose concentration of 177.8 ± 11.9mg/dl compared to 225.1± 10.7mg/dl with Humalog Mix 75/25 treatment (p<0.001). Mean glucose concentrations after the standardized breakfast were 167.8 ± 10.4mg/dl with BIOD-531 treatment compared to 193.1 ± 8.3mg/dl with Humulin R U-500 treatment (p=0.006). Mean glucose concentrations were 177.8 ± 11.9mg/ dl with BIOD-531 treatment compared to 197.2 ± 8.8mg/dl with Humulin R U-500 treatment (p=0.042). Over the course of the entire day of observation, glucose concentrations were in the target range of 70-180mg/dl 46.3 ± 8.4% of the time with BIOD-531 treatment compared to 29.1 ± 6.1% of the time with Humulin R U-500 treatment (p=0.032). Post-meal administration of BIOD-531 v. pre-meal administration of Humalog Mix 75/25 and pre-meal administration of Humulin R U-500 BIOD-531 dosed 20 minutes after the start of the standardized breakfast also resulted in a superior glucose control compared to either Humalog Mix 75/25 or Humulin R U-500 dosed prior to the meal. Mean glucose concentrations were 178.3 ± 11.2mg/dl for post-meal BIOD-531 treatment compared to 225.1 ± 10.7 for pre-meal Humalog Mix 75/25 treatment (p<0.001). The percentage within the 70-180mg/dl target range was 46.2 ± 7.6% for post-meal BIOD-531 treatment compared to 20.6 ± 5.9% for pre-meal Humalog Mix 75/25 treatment (p=0.003) and 29.1 ± 6.1% for premeal Humulin R U-500 (p=0.040).

Collegium Pharmaceutical issued results of a phase III study of Oxycodone DETERx for the treatment of patients with moderate-to- severe chronic low back pain. The phase III study was a multicenter, double-blind, enriched-enrollment, randomized-withdrawal, placebo-controlled study of Oxycodone DETERx versus placebo in opioid-experienced and opioid-naïve subjects with moderate-to-severe chronic low back pain. Patients who achieved a stable and effective dose of Oxycodone DETERx during the open-label titration phase were randomized (n=389) into the 12-week, double-blind maintenance phase, in which they either were maintained on their current dose regimen of Oxycodone DETERx or were tapered to placebo. The primary efficacy endpoint of the study was the change in average pain intensity from baseline to week 12; pain was measured using an 11-point pain intensity numerical rating scale (PI-NRS). The study met the primary efficacy endpoint, showing patients with chronic low back pain treated with Oxycodone DETERx experienced a statistically significant reduction in pain compared with placebo (p< 0.0001). The company is positioned to file an NDA with the FDA for Oxycodone DETERx by the end of 2014.

Salix Pharmaceuticals reported results of a phase III study of rifaximin for the treatment of irritable bowel syndrome with diarrhea (IBS-D). The phase III, randomized, double-blind, placebo- controlled study evaluated repeat treatment with rifaximin 550mg TID (three times daily) for 14 days in subjects with IBS-D, who respond to an initial treatment course with rifaximin 550mg TID for 14 days. Results indicate a significantly greater proportion of rifaximin-treated subjects, compared to placebo-treated subjects, gained relief in both IBS-related abdominal pain and stool consistency during the PEP in the first repeat double-blind, placebo-controlled treatment phase, and continued to respond without recurrence through the end of week six following the second repeat double-blind, placebo-controlled treatment (p=0.0068). Results also indicate, compared to placebo-treated subjects, a significantly greater proportion of rifaximin-treated subjects gained relief in both IBS-related abdominal pain and stool consistency during the PEP in the first repeat double-blind, placebo- controlled treatment phase and continued to respond without recurrence through the end of week 12, independent of any additional treatment (p=0.0419).

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