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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 December 22, 2014

Cynapsus Therapeutics issued results from a phase II study of APL-130277 for the management of OFF motor symptoms of Parkinson’s disease. In the multicenter, open-label study, APL-130277 was assessed in 16 patients with Parkinson’s disease who experience OFF episodes, with a total duration of OFF of at least two hours daily. Patients were then given escalating doses of APL-130277 (at a minimum of three hours between doses) until ON was achieved. All five doses of APL-130277 used in the study (10mg, 15mg, 20mg, 25mg and 30mg) resulted in patients moving from OFF to ON. The onset of a clinically meaningful improvement was seen in as early as 10 minutes and lasted up to 90 minutes, the last time point measured in this study. The mean time to ON as reported by study staff was 22 minutes. Preliminary data show several subjects converted to ON with the 10mg low dose, and 14 of 16 subjects converted ON with all available doses. The maximum mean change from baseline Unified Parkinson’s Disease Rating Scale (UPDRS) III was 18.4, which is a large clinically important difference. APL-130277 treatment was safe and well-tolerated, with no local irritation, no postural hypotension and a low number of nausea events. Cynapsus is planning to conduct pivotal studies of longer duration and with larger patient numbers to confirm these results. These pivotal studies are expected to form the registration package necessary for a 505(b)(2) New Drug Application with the FDA expected to be submitted in 2016.

Poxel reported results of a phase IIb study of Imeglimin for the treatment of type 2 diabetes. The phase IIb trial assessed the efficacy and safety profile of four doses of Imeglimin in 382 patients after 24-week treatment. In addition to the HbA1C and FPG reductions obtained with the 1,500mg dose, the number of responders (defined as patients achieving an HbA1C below 7% at the end of the treatment) was statistically significant (p=0.005) and no patient required rescue therapy (p=0.01) during the trial’s duration. The trial achieved its primary endpoint of HbA1c reduction v. placebo (p<0.001) and significant decrease in FPG (Fasting Plasma Glucose) (p<0.006) at a dose of 1500mg, which will be the dose Poxel will advance into a phase III development program. The overall safety and tolerability profile was positive in all Imeglimin groups, with a similar overall incidence of adverse events between treatment groups and placebo group. The trial reported no serious adverse events related to the treatment with Imeglimin.

Trevena released results from its randomized, double-blind, placebo- and active-controlled phase II trial of TRV130 in moderate-to-severe postoperative acute pain. Doses of 2mg and 3mg of TRV130 at three-hour intervals achieved a statistically significant reduction in pain intensity difference from placebo over 48 hours, measured as the time-weighted average change in pain score (TWA0-48). At 2mg, TRV130 reduced average pain score (LS mean change in TWA0-48) by 1.4 points (p=0.0024 v. placebo; all p-values 1-sided). At 3mg, TRV130 reduced LS mean TWA0-48 by 2.4 points (p<0.0001 v. placebo). TRV130 achieved a reduction in mean pain intensity of up to approximately six points, with notable efficacy at five minutes, the first pain intensity assessment after dosing. Over 48 hours, 3mg of TRV130 at three-hour intervals achieved a statistically significant reduction in pain intensity difference from 4mg morphine at four-hour intervals, reducing average pain score (LS mean change in TWA0-48) by one point v. morphine (p=0.014). When study pain was most severe, during the first three hours after the initial dose, TRV130 at 1mg, 2mg and 3mg showed a statistically significant reduction in pain (TWA0-3) v. placebo (LS mean change -1.0, -2.4, and -3 respectively; p=0.021, p<0.0001 and p<0.0001, respectively). More patients reported statistically greater peak pain relief during the first dosing period for 2mg and 3mg TRV130 compared to 4mg morphine (p=0.005 and p<0.0001 for TRV130 2mg and 3mg v. morphine, respectively). A phase III study is planned.