Invitation to International Neurotrauma Community to Submit Proposals for Candidate Drugs for TRACK-TBI NET Phase 2 Trials

Submission Deadline January 28, 2019

The TRACK-TBI Clinical Trials Network (TRACK-TBI NET) will conduct Phase 2 clinical trials of drug prototype candidate(s) for TBI, with the goal of identifying treatments with the best chance for success in a Phase 3 trial. The end goal is a commercial drug product approved by the FDA to treat TBI and its sequelae.

The broad classes of compounds that TRACK-TBI NET will consider for trials are:

(1) Novel compounds under development by pharma/biotech/academic investigators: Neurotrauma investigators are developing a wide range of novel chemical entities that show promise in experimental models of TBI. We are confident that the Network will be an attractive partner to industry for conducting Phase 2 studies in an efficient and scientifically rigorous manner.

(2) Repurposed drugs: Pharmaceuticals that are FDA-approved and in clinical use for other medical conditions, and have substantial preclinical data and clinical observations supporting their role in neuroprotection and neuroplasticity, are attractive candidates for TRACK-TBI NET.

3) Nutraceuticals: Several nutraceuticals show potential, either as neuroprotective agents or promoters of neuroregeneration. Compounds in wide use as dietary supplements are regulated by FDA using standards that differ from those applied to drugs.

To propose a candidate drug agent, please submit a Clinical Trial Synopsis that discusses the following criteria:

  • Submitting Team: All Members and Lead Contact information
  • Patient population targeted, the use of prognostic, predictive, and pharmacodynamics biomarkers, and proposed outcome measures
  • Strength of scientific rationale including mechanism of action, pre-clinical data to include peer reviewed publications and good laboratory practices (GLP) animal safety and toxicity studies
  • FDA-approved Investigational New Drug (IND) application for human TBI studies, if appropriate
  • Results of Phase 1 study in humans regarding toxicity/tolerability, and availability of PK and PD data for the compound relevant to dose selection
  • In cases of repurposed drugs, evidence of efficacy in human disease, results of Phase II and Phase III clinical trials
  • Known or potential drug interactions with drugs commonly used in neurological intensive care units
  • Current financial health and business plan to include funding/investment source partners (gov/private) and investment status
  • Manufacturing and Distribution capabilities and partnerships - Current stock of drug and placebo; weight, volumes, doses, and ability to produce under good manufacturing practices (GMP) conditions
  • Storage, transport, and distribution details of drug and placebo; production and dissemination; current operations and/or plans, temperature stability
  • Intellectual property and patent right assertions in US and abroad
  • Experience - have submitters and/or their partners obtained FDA approval and marketed other solutions

Submission Instructions

  • Submission deadline: by or before January 28, 2019 at 5pm Pacific
  • Submission address: [email protected]
  • Format: 4-page limit (exlusive of the Submitting Team information and references), single spaced; Arial 12 font; .5 margins on all sides; in .pdf format
  • Email subject line: Submitter Name and “CLINICAL TRIAL SYNOPSIS”
  • All submissions will be confirmed by TRACK-TBI NET via email; for questions regarding submission, please contact: Brian Fabian ([email protected])

The TRACK-TBI NET Executive Committee and USAMMDA will review all Synopses and will communicate to the sponsoring company or investigator regarding the candidate’s suitability for further consideration by or before March 15, 2019. Submitters with appropriate candidates will be invited to provide further information at individual presentations to be held on April 25-26, 2019 in Denver, CO.

Download Invitation Letter