The Intrepid2566 trial is expected to seek to enroll a total of 260 patients with moderate to severe brain injury. Patients will be randomised 2:1 for drug and placebo and stratified 2:1 in favour of drug versus placebo.
In addition to safety, the study includes two endpoints that measure overall patient function, a wide range of neuropsychological measures and physiological assessments in the form of EEG monitoring and serum-based biomarkers.
Neuren Pharmaceuticals said that the patient enrollment is expected to take approximately 18 months. In addition to the 12 sites already committed to the study, backup sites have been identified in the event that enrolment is slower than anticipated.
While the Phase II trial is running, Neuren is expected to undertake additional preclinical and clinical studies that are necessary to engage in a pivotal or registration trial. These include reproductive toxicology studies in animals, a cardiovascular safety study in human volunteers and a safety and pharmacokinetics study in female volunteers, the latter a requirement for enrolling women in the Phase II and subsequent trials.
Reportedly, the reproductive toxicology studies have been initiated as has the safety and pharmacokinetics study in females which is being conducted at Nucleus Network Limited’s Centre for Clinical Studies in Melbourne. The first cohort of the safety and pharmacokinetics study has been completed with no adverse events reported.
Larry Glass, CEO of Neuren Pharmaceuticals, said: “We are confident that the study’s design and the painstaking groundwork that has been laid will pay off in the successful execution of the trial. Knowing that, between the financing announced at the end of 2009 and funding from the US Army, we have access to all of the capital resources needed to complete the study contributes significantly to our level of confidence.
“Most importantly, however, as this trial begins, we are hopeful that we will be able to answer the desperate need for a drug that can make a real difference for the hundreds of thousands of people worldwide who suffer a brain injury each year.”