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Research

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 October 27, 2014

ChemoCentryx issued results of a phase III study of vercirnon for Crohn’s disease. The randomized, double-blind induction study in patients with moderate-to-severe Crohn’s disease enrolled 253 subjects. The primary endpoint of the trial was the proportion of patients with a Crohn’s disease activity index (CDAI) = 100-point response (100-point decrease in CDAI score) at week 12. The secondary endpoint was the proportion of patients in clinical remission (CDAI <150) at week 12. Adult patients with a baseline CDAI of 220 to 450, C-reactive protein (CRP) = 3mg/L or fecal calprotectin >200μg/g were randomized to receive either 500mg QD or 500mg BID vercirnon for 12 weeks. Baseline CDAI was 323 (± 56) with a range of 220-450. Of those who completed the trial prior to the premature study termination (n=118), the CDAI = 100-point response at week 12 was 56% and 69% in the 500mg QD and in the 500mg BID groups, respectively. In the same population, remission (defined as CDAI <150) at week 12 was 26% and 36% in the 500mg QD and in the 500mg BID groups, respectively. The increase in response and remission rates with the higher dose of vercirnon in contrast to the lack of dose response observed in a previous trial. There were no safety issues observed in the trial and gastrointestinal adverse events were not higher in the 500mg BID group than the 500mg QD group. There were no cardiac safety or liver toxicity signals.

Hepatera reported results of two phase IIa studies of Myrcludex B in patients with chronic hepatitis B (HBV) and delta (HDV). A phase IIa trial investigating effects of several Myrcludex B doses in 40 patients with chronic HBV infection showed the drug was well-tolerated. A dose-dependent effect on HBV DNA was observed: >1 log10 HBV DNA decline at week 12 occurred in 6/8 (75%) patients receiving 10mg Myrcludex B, while this occurred less often in the remaining dose groups (7/40; 17%). The HBV DNA response was maintained in 10mg patients through week 24. In a phase IIa trial in chronic HDV infection with 24 patients, Myrcludex B was investigated as monotherapy v. combination with pegylated interferon alpha for 24 weeks; a control arm received pegylated interferon alpha alone. Myrcludex B was well-tolerated both as monotherapy and in combination with interferon. Myrcludex B has shown strong single agent efficacy against HDV. Six out of seven evaluable patients experienced >1 log10 HDV RNA decline at week 24; two patients became HDV RNA negative and in two others the values dropped below the limit of quantification. In the combination arm, all patients had HDV RNA decline and five were HDV RNA negative at week 24. Importantly, ALT normalized in four Myrcludex B monotherapy patients at week 24.

Repros Therapeutics reported results of a phase III study of Androxal (ZA-303) to evaluate the effects on bone mineral density of administration of Androxal for 52 weeks to overweight men with acquired hypogonadotropic hypogonadism. The study enrolled 317 men younger than 60 years old with BMI greater than 25 if they had morning testosterone of <300ng/dL on two screening visits. The single-blind, placebo-controlled, multi-center study initiated dosing at 12.5mg and dose escalated as necessary to 25mg. Of enrolled subjects, 213 and 104 subjects were treated with Androxal and placebo, respectively. The study results showed no evidence of a negative effect on bone mineral density in subjects treated with Androxal in comparison to the placebo treatment group. However, placebo-treated subjects experienced a statistically significant decrease from baseline in Total Hip bone mineral density (-0.63%) than subjects treated with Androxal (0.01%, p = 0.0043). The percentage of Androxal-treated subjects obtaining a morning testosterone over 300ng/dL in a 12-month treatment window was 79.3%, and 71.4% had a normal testosterone at their last observation on treatment. Androxal was well-tolerated. Repros plans to file an NDA for Androxal at the end of 2014.

 
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