– Phase 1 safety study of NTS-104 is initiated in healthy volunteers –
– Compound is being developed for stroke and other Central Nervous System (CNS) injuries –
ATLANTA, GA, June 1, 2023 – NeuroTrauma Sciences, LLC (NTS), a private biopharmaceutical company developing neuroprotective therapeutics for treating patients with stroke and other CNS injuries, today announced that it has commenced dosing in a Phase 1 study of its investigational drug NTS-104, in healthy volunteers.
The single-dose, randomized, double-blind, placebo-controlled, Phase 1 single-center dose-escalation study will assess the safety, tolerability, and pharmacokinetics of intravenous NTS-104 in healthy US participants. The study is expected to enroll a total of 32 participants across four cohorts. For more information, please visit www.clinicaltrials.gov. (NCT05547438)
“First-in-human dosing of our novel drug, NTS-104, is an important achievement for NTS,” said Carl Long, Chief Executive Officer. “NTS-104 represents a compelling approach to neuroprotection with the objective of improving neurologic recovery and function in millions of patients worldwide. Our principal developmental focus is in stroke, where there are few effective treatments and a tremendous unmet need. Additionally, NTS’s extensive preclinical study program demonstrates NTS-104’s potential to treat multiple forms of brain injury.”
NTS-104 is a novel, water-soluble neurosteroid prodrug that, when delivered intravenously, is converted in the bloodstream to NTS-105, the active neurosteroid. NTS-105 rapidly enters the brain at concentrations sufficient to modulate key target receptors, protecting neurons from inflammation, edema, and programmed cell death. NTS-104 has demonstrated efficacy in multiple preclinical brain injury models validated at independent laboratories. NeuroTrauma Sciences plans to conduct a Phase 2 study of NTS-104 in acute ischemic stroke.
About NeuroTrauma Sciences
NeuroTrauma Sciences is a biopharmaceutical company advancing its mission to develop neuroprotective therapies for treating patients with stroke and other CNS injuries. By leveraging insights into the biology of CNS injury, NTS is advancing a pipeline of therapeutic candidates targeting ischemic stroke and CNS injuries. For additional information, please visit www.neurotraumasciences.com.
Chief Financial Officer