NeuroNEXT

Network successes and the five-year renewal application were presented at the 2018 Annual Meeting of the American Society for Experimental Neurotherapeutics poster session. The poster, presented March 9 at the meeting’s poster presentation and reception, concluded that NeuroNEXT has met all of its initial goals within the first 7-year funding period; that Network sites hae demonstrated their capacity to effectively enroll subjects; and that the Network is primed for future collaborations with industry, academia and small business partners.

In the same issue where the NN101 SMA primary results were published, the Annals of Neurology also published an accompanying editorial with high praise for the Network. The authors noted that “NeuroNEXT is clearly trying to change the landscape of clinical trials in neurology, helping to empower the academic investigator to pursue research efforts that would otherwise be impossible.”

Results of the NN104 study were covered  in the San Diego Union-Tribune. The article details the development of 3K3A-APC, the study drug, originally developed by The Scripps Research Institute in La Jolla, CA.

Final results from the NN104 RHAPSODY trial, which were presented at the International Stroke Conference (ISC) 2018 as a closing event, were subsequently featured in ISC’s Science News as Featured Science and on the American Stroke Association blog “Blogging Stroke.”

The FDA released several guidance documents in February, 2018, three of which fall under the NeuroNEXT umbrella: ALS, DMD and Migraine.

Article Summary: In February, 2012, the US National Institute for Neurological Disorders and Stroke (NINDS) is due to announce the first study to be supported by the National Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT). With this ambitious new network, NINDS aims to facilitate the progress of new drugs from the laboratory to the clinic, specifically at the stage of phase 2 trials and biomarker validation studies. New therapies for neurological diseases are undoubtedly needed, but how can NeuroNEXT make a difference?

View Steve Kolb’s video announcement of the NN101 SMA study.

Please visit the NIH page for information related to the NeuroNEXT Clinical Trials (U01 Clinical Trial Optional) funding mechanism.  The FOA is available for applications beginning January 5, 2018, through January 8, 2021.

MediciNova, the industry sponsor of NN102 SPRINT-MS, announced the positive top-line results from the trial. The second funded NeuroNEXT trial, a study to evaluate the activity, safety, and tolerability of Ibudilast in patients with Multiple Sclerosis (MS), has very promising results for MS treatment. Results indicate that Ibudilast demonstrated a statistically significant reduction in the rate of progression of whole brain atrophy as compared to placebo.

The August 2013 issue of Annals of Neurology describes how NeuroNEXT can streamline neurological research.