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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 October 24, 2016

AbbVie issued results of two replicate pivotal phase III trials of Elagolix in premenopausal women who suffer from endometriosis. The first pivotal trial (M12-665) was a 24-week, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of Elagolix in 872 women, age 18 to 49, with moderate to severe endometriosis-associated pain. It was conducted at 175 sites in the U.S., Puerto Rico and Canada. The second trial (M12-671) employed the same design as the first trial, was multinational and included 815 women with moderate to severe endometriosis-associated pain across 226 sites in 13 countries (U.S. and 12 ex-U.S. countries). Together, these two studies evaluated the safety and efficacy of Elagolix in nearly 1,700 women. In the two studies, both doses of Elagolix administered orally demonstrated a statistically significant (p≤0.001) improvement versus placebo in the percentage of DYS and NMPP responders. In the first study, at month three, 46% of patients treated with 150mg once daily and 76% of patients treated with 200mg twice daily of Elagolix were classified as DYS responders, versus 20% of patients in the placebo group. Fifty percent of patients treated with 150mg once daily and 55% of patients treated with 200mg twice daily of Elagolix were classified as NMPP responders, versus 36% of patients in the placebo group. The second pivotal phase III study demonstrated similar results. The safety profile of Elagolix was consistent across both phase III trials and also consistent with prior Elagolix studies. Discontinuations due to AEs were 5.9% and 6.1% for placebo in study 1 and study 2, respectively, 6.4% and 4.4% for 150mg once daily in study 1 and study 2, respectively, and 9% and 10% for 200mg twice daily in study 1 and study 2, respectively.

Omeros announced positive results from a phase II clinical trial evaluating the effects of a peroxisome proliferator-activated receptor (PPAR)-gamma agonist in patients with cocaine use disorder (CUD). In the double-blind, placebo-controlled trial, 30 treatment-seeking CUD patients were randomized to receive either a PPAR-gamma agonist (n=15) or placebo (n=15) daily for 12 weeks. Measures of impulsivity, decision-making and cocaine craving were recorded at multiple time points. A subgroup of 19 patients (10 placebo patients and 9 PPAR-gamma-treated patients) underwent brain scans using diffusion tensor imaging (DTI) to measure white matter integrity before and after the course of treatment. The data reveal a statistically significant time-dependent reduction in cocaine craving in PPAR-gamma-agonist-treated patients compared to placebo controls. Treated patients also showed improvement in white matter integrity in four target DTI regions of interest, specifically in the corpus callosum and in two associated thalamic tracts. During treatment, side effects reported were minimal and similar between the PPAR-gamma agonist and placebo groups. These clinical findings are consistent with results of earlier mechanistic and target-based preclinical studies showing that PPAR-gamma agonists protect against neuronal damage and block reinstatement of cocaine, heroin and alcohol seeking in animal models of drug abuse. 

OncoGenex Pharmaceuticals released results of a phase III trial of custirsen in patients whose non-small cell lung cancer (NSCLC) has progressed following initial treatments. The ENSPIRIT trial is an international, randomized, open-label trial. The trial investigated if combining custirsen with docetaxel, a standard second-line NSCLC chemotherapy, has the potential to improve survival outcomes compared to docetaxel alone in these patients. The trial enrolled 664 patients at approximately 50 sites globally. The trial did not meet the primary endpoint of demonstrating a statistically significant improvement in overall survival for patients treated with custirsen in combination with docetaxel compared to docetaxel alone. The median overall survival for the custirsen arm was nine months versus 7.9 months for the control arm with a hazard ratio of 0.915 (one-sided p=0.178). Safety results were consistent with those observed in previous trials of custirsen in combination with chemotherapy.

Trevi Therapeutics reported results of a phase II study of Nalbuphine ER for the treatment of moderate to severe prurigo nodularis. The multicenter, randomized, double-blind, placebo-controlled, parallel, three-arm study evaluated the safety and anti-pruritic efficacy of Nalbuphine ER tablets dosed twice-daily at 90mg and 180mg in 62 patients in the U.S. and Europe. Patients with moderate to severe itch intensity, defined as ≥5 on the zero to 10 Numerical Rating Score (NRS) scale, were enrolled to evaluate drug efficacy across a representative patient population for treatment of this chronic indication. The actual average baseline worst itch for enrolled patients was ≥8, indicating the severe nature of the disease. The main outcome variables for this study were responder analyses of the proportion of patients with at least a 30% or 50% reduction in their seven-day worst itch intensity NRS from baseline to completion of treatment at week 10 or last observation visit. The proportion of patients in the Nalbuphine ER 180mg BID arm meeting 50% responder criteria at week 10 or last observed visit (MITT population with n=18) approached statistical significance (p=0.083), and this arm met statistical significance for patients (n=12) completing treatment (p=0.028). The mean change in worst itch NRS was additionally evaluated, and the MITT population of the Nalbuphine ER 180mg BID arm as compared to placebo approached statistical significance (p=0.083) as well. This arm also met statistical significance for patients (n=12) completing treatment (p=0.025). The company expects the open label extension study to be completed in the third quarter of 2017.

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