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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 April 21, 2014

Adocia released results of a phase IIa trial of BioChaperone Lispro in comparison to Eli Lilly’s Humalog commercial insulin for type 1 diabetes. In this double-blind, crossover study, the pharmacokinetic and pharmacodynamic characteristics of BioChaperone Lispro were compared to those of Humalog in 36 patients who received single 0.2U/kg doses of BioChaperone Lispro and Humalog under automated euglycemic clamp conditions (ClampArt, target blood glucose 100mg/dL, clamp duration six hours post-dosing). BioChaperone Lispro had a significantly faster rate of absorption than Humalog with an increase in the early insulin exposure of 170% (primary endpoint, AUCLispro_0-30min 23.7 ± 11.4 v. 9.5 ± 6.2 hmU/L; p<0.0001). The time to peak insulin concentration was reduced by more than 35% (Tmax 42 ± 11 v. 69 ± 22 min; p<0.0001). BioChaperone Lispro was cleared from the blood significantly earlier than Humalog, reflected in the time to half-maximum insulin levels after Tmax (late T 50% max = 141 ± 43 v. 173 ± 41 min, p<0.0001). The acceleration of insulin Lispro absorption translated into a significant acceleration of insulin action. The metabolic effect is triggered significantly earlier for BioChaperone Lispro than for Humalog with 30% faster onset of action (T onset = 23.1 ± 7.0 v. 34.4 ± 15.3 min; p<0.0001). The early metabolic effect is increased by 69% relative to Humalog during the first hour after administration (AUCGIR_0-1h = 218 ± 88 v. 129 ± 63mg/kg; p<0.0001). The time to reach the maximal observed hypoglycemic effect is significantly shorter relative to Humalog (TGIR_max = 99 ± 42 v. 133 ± 45 min; p=0.0002). Another clinical trial is planned to start in Germany.

Biogen Idec and Swedish Orphan Biovitrumreported results of a phase III trial of ELOCTATE for the treatment of children under 12 with severe hemophilia A. The global, open-label, multi-center study involved 71 boys with severe hemophilia A (factor VIII activity less than 1IU/dL, or 1%) with at least 50 prior exposure days to factor VIII therapies. The study was conducted at 23 hemophilia treatment centers in eight countries. Overall, 67 participants (94%) completed the study (33 under six years old and 34 six-to-11 years old). The average time participants spent in the study was 25 weeks, and 61 participants received ELOCTATE infusions on at least 50 separate days (exposure days) to assess inhibitor development. All study participants were to be initially treated with twice-weekly prophylactic infusions of ELOCTATE [25IU/kg day one, 50IU/kg day four]. Study investigators could adjust the dose or interval based on individual response. Approximately 90% of study participants were on twice-weekly dosing at the end of the study. The relative increase in half-life in children with severe hemophilia A was consistent with the 1.5-fold increase in half-life seen in the A-LONG study of adults and adolescents. Children treated prophylactically with ELOCTATE had an overall median ABR of two and a median ABR for spontaneous bleeds of zero. Forty-six percent of participants in the study experienced zero bleeding episodes. Overall, 93% of bleeding episodes were controlled by one to two infusions of ELOCTATE. ELOCTATE was generally well-tolerated. This is considered a milestone that will enable regulatory submission in Europe.

Gilead Sciences reported results of a phase II studies of sofosbuvir (SOF) for the treatment of chronic hepatitis C virus (HCV) infection. The ongoing, open-label trial evaluated SOF 400mg and the NS5A inhibitor ledipasvir (LDV) 90mg, with and without ribavirin (RBV) twice-daily (1,000mg/day or 1,200mg/day), among HCV-infected patient populations. 100% (n=26/26) of treatmentnaïve genotype 3 patients receiving 12 weeks of LDV/SOF plus RBV and 64% (n=16/25) of treatment-naïve genotype 3 patients receiving 12 weeks of LDV/SOF without RBV achieved a sustained virologic response 12 weeks after completing therapy (SVR12). Among genotype 1-infected patients who had failed prior treatment with SOF plus RBV, 100% (19/19) achieved SVR12 following 12 weeks of LDV/SOF plus RBV. Additionally, 65% (n=13/20) of genotype 1-infected patients with decompensated or Child-Turcotte-Pugh Class B cirrhosis receiving 12 weeks of LDV/SOF without RBV achieved SVR12. The EMA accepted a request for accelerated assessment for LDV/SOF.