Trial Results

Elite Pharmaceuticals Reports Positive Topline Results From SequestOx Pilot Study

February 5, 2018

Elite Pharmaceuticals reported positive topline results from a pilot study conducted for SequestOx, Elite’s immediate release Oxycodone Hydrochloride product that incorporates its proprietary abuse-deterrent technology. An objective of the study was to assess whether the reformulated SequestOx could achieve a Tmax (the mean or median time to the maximum drug concentration in subjects) comparable to the reference drug, Roxicodone, when dosed with the standard high fat meal specified by the FDA. As opposed to the earlier formulation, based on pilot results, the modified SequestOx is expected to achieve bioequivalence with a Tmax range equivalent to the reference product when conducted in a pivotal trial under fed conditions. Elite intends to review with the FDA the study results and discuss the pharmacokinetic study requirements for a re-submission of the NDA. The study was a Phase I pilot, randomized, single-dose, single period, pharmacokinetic study in healthy male and female volunteers in the fed state.

Sunovion’s Parkinson’s Drug Succeeds in Late-Stage Trial
Sunovion Pharmaceuticals announced topline results from its pivotal Phase III, randomized, double-blind, placebo-controlled clinical trial, CTH-300, that evaluated apomorphine sublingual film (APL-130277) in patients with Parkinson’s disease (PD) who experience motor fluctuations (OFF episodes). The Phase III study met its primary endpoint, with initial results from 109 adults with PD showing that individuals with OFF episodes who received apomorphine sublingual film demonstrated a statistically significant mean reduction in the Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III score from pre-dose to 30 minutes after dosing at week 12 compared with the placebo group, with effects persisting until the last observed time point at 90 minutes. The difference in MDS-UPDRS Part III score change from baseline 30 minutes after dosing between apomorphine sublingual film and placebo was 7.6 (p=0.0002). Apomorphine sublingual film was generally well-tolerated in the study population. The most commonly reported treatment-emergent adverse events during both the titration and maintenance treatment phases were nausea (27.0 percent), somnolence (14.9 percent), dizziness (14.2 percent), yawning (12.8 percent) and headache (9.2 percent).

Positive Data From Adocia’s Dose-Proportionality Study
Adocia announced positive topline results from a Phase Ib clinical trial evaluating the dose exposure and dose response relationships of BioChaperone Combo 75/25 at three different doses in people with type 2 diabetes. BioChaperone Combo is a proprietary formulation combining basal insulin glargine (active ingredient in Lantus, Sanofi and Basaglar, Eli Lilly) and prandial insulin lispro (active ingredient in Humalog, Eli Lilly and Admelog, Sanofi). This study aimed to document the dose exposure relationship of BioChaperone Combo in people with type 2 diabetes. In the double-blinded, randomized, four period crossover trial, using automated 30-hour euglycemic clamp, 32 participants with type 2 diabetes mellitus were randomly allocated to a sequence of four treatments, i.e. one of three single doses of BioChaperone Combo 75/25 (0.6 U/kg; 0.8 U/kg or 1.0 U/kg) or one single dose of Humalog Mix25 at 0.8 U/kg. The primary endpoints were the assessments of dose-proportionality for total insulin exposure (AUCtotal_insulin 0-last) and maximal observed total plasma insulin concentration (Cmax) across three doses of BioChaperone Combo. Both primary endpoints were met (AUC0-last overall dose exposure slope 0.93; 95% confidence interval [0.58 ; 1.29]; Cmax overall dose exposure slope 0.80, 95%CI [0.43 ; 1.17]) and a dose-proportionality relationship was demonstrated for all exposure pharmacokinetic parameters assessed in the early, intermediate and basal phases.

Cerus Reports Results from INTERCEPT Study
Cerus reported that the primary efficacy and safety endpoints were successfully achieved in the company’s Phase III transfusion study of chronic anemia evaluating INTERCEPT-treated red blood cells (RBCs) in thalassemia patients, SPARC. A total of 86 patients were enrolled at three participating international sites in the double blinded, cross-over study. Subjects were randomly assigned to a sequential treatment period of either INTERCEPT-treated RBCs or conventional RBCs with cross over to the other treatment upon completion of the first treatment period. The study’s primary efficacy endpoint used a non-inferiority design to assess up to a 15% relative difference in the mean consumption of hemoglobin between INTERCEPT-treated RBC and conventional RBC.