US – Ischemix, a privately owned company focused on developing therapeutics for serious medical conditions, has received funding worth US$2.9M from the US department of defense (USDoD) to conduct its phase 1 study of a traumatic brain injury (TBI) drug.
This fund was granted by US Army Medical Research and Development Command (USAMRDC), Combat Casualty Care Research Program (CCCRP) in collaboration with the Medical Technology Enterprise Consortium (MTEC), a 501(c)(3) biomedical technology consortium.
The funding is meant pay for a substantial portion of manufacturing and formulating additional supply of the drug candidate as well as cater for the cost of conducting trials.
“We are pleased to have received this second award from DoD/MTEC for the development of our novel compound for treating TBI,” said Geoffrey E. Clark, Chairman and Chief Medical Officer of Ischemix. “This compound aims to improve the health outcomes of TBI patients in military and civilian populations, thereby increasing patients’ quality of life and reducing the economic and social costs to society.”
“We have assembled a highly experienced team of partners in drug manufacturing and formulation and in clinical trial management to work with us on this Phase 1 trial,” said David DeWahl, President and CEO of the Company. “We are excited to commence this important phase of the development of our proprietary drug candidate to treat TBI.”
The drug CMX-2043, a multi-modal cytoprotective compound based on a naturally-occurring molecule present in the human body, has previously demonstrated safety and efficacy in preclinical models of TBI.
Phase 1 trials will evaluate how safe the drug is on healthy volunteers and will be grouped in single ascending dose (SAD) and multiple ascending dose (MAD).
The SAD will have five sequential dose groups with eight patients per group and the MAD will have four sequential dose groups with 10 patients per group.
TBI is a condition for which there are currently no approved pharmaceutical therapies available. The Center for Disease Control (CDC) reports that in the US in 2014, there were about 2.9 million TBI-related emergency department visits.
It is estimated that each year TBI is responsible for 60,000 deaths and causes 80,000 individuals to have permanent disabilities as annual direct and indirect cost of TBI in the US totaling approximately to US$77 billion.
The US DoD reported 434,681 TBIs among its worldwide service members in the period 2000 – 2020 and 16,198 TBIs in 2020.
Ischemix is hopeful that the first trial phase of the drug will relay positive data that will further help it progress to the next stage of developing it further.