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

Severe and Penetrating TBI

Submission Deadline September 8, 2023

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

The broad classes of compounds that TRACK-TBI NET will consider for conducting Phase 2 studies using an adaptive platform trial design 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 and other partners 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, with 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
  • IV and/or IM route of administration and proposed acute dosing regimen
  • Patient population targeted (Severe/Penetrating TBI-GCS 3-8) evidence for prognostic, predictive, and/or pharmacodynamic biomarkers as a primary or secondary endpoints of efficacy, 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) as well as animal safety and toxicity studies
  • FDA-reviewed New Drug Application (NDA) and/or Investigational New Drug (IND) application for human TBI studies, if available
  • 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 2 and Phase 3 clinical trials
  • Known or potential drug interactions with drugs commonly used in neurological intensive care units
  • Current financial health and business plan of submitter, 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

Clinical Trial Synopsis Submission Instructions

  • Submission deadline: by or before September 8, 2023 at 5pm Pacific
  • Submission address: [email protected]
  • Format: 4-page limit (exclusive 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 US Army Medical Materiel Development Activity (USAMMDA) will review all Synopses and will communicate to the submitter regarding the proposed candidate’s suitability for further consideration by or before October 25, 2023. Submitters with appropriate candidates will be invited to provide further information at in-person individual presentations to be held at an Industry Day Meeting on either December 5 or December 6, 2023 in Denver, CO.