(MENAFN- EIN Presswire)
PRINCETON, NJ, UNITED STATES, October 28, 2024 /EINPresswire / -- SHINKEI Therapeutics, a clinical-stage
Pharmaceutical company dedicated to developing treatments for central nervous system (CNS) disorders, is pleased to announce that it has initiated enrollment and dosing in SHINKEITBI, a Phase 2 clinical trial of MR-301 in patients with severe traumatic brain Injury (TBI ).
Since no approved drug therapy exists to treat disorders of consciousness after TBI, there is a current unmet clinical need for an approved therapy.
Suresh Borsadia, Chief Executive Officer, stated“the initiation of patient dosing in the SHINKEITBI Phase 2 trial marks a significant milestone for SHINKEI Therapeutics, as it advances its lead program into clinical development.”
The SHINKEITBI Phase 2 trial is a multicenter, randomized, placebo-controlled study expected to enroll approximately 45 patients. SHINKEI is conducting the study across several sites within the United States. The trial is being conducted by Duke Clinical Research Institute (DCRI). Further details of the trial can be found at under NCT identifier: NCT06253923.
About Traumatic Brain Injury (TBI)
Traumatic brain injury (TBI) remains a leading cause of mortality in the United States, accounting for approximately one third of injury-related deaths in the United States. Even patients surviving TBI may still be burdened with long-lasting or permanent disability, which significantly impacts their independence and quality of life. Currently, no approved drug therapy exists to treat disorders of consciousness after TBI. Thus, there is a current unmet clinical need for an approved therapy, which allows these patients to recover more rapidly.
About MR-301
MR-301 – Amantadine HCl Intravenous (IV) Solution - is SHINKEI's most advanced program. Amantadine HCl is one of the most commonly prescribed off-label medications for patients with prolonged disorders of consciousness after TBI. Amantadine HCl increases dopamine availability in the synapse by inhibiting the activation of dopaminergic receptors. Amantadine HCl has been approved as a prescription oral product in the U.S since 1966 and, as such, has a long history of safe use in the U.S. and globally. Preliminary studies in preclinical models and patients with TBI have suggested that amantadine may promote functional recovery with high levels of safety.
About SHINKEI Therapeutics
SHINKEI Therapeutics is a clinical-stage pharmaceutical company focused on CNS disorders. Our robust and diverse product development pipeline aims to enhance drug administration for new indications, increase convenience, improve compliance, and reduce side effects for patients. SHINKEI Therapeutics is headquartered in Princeton, New Jersey. For more information, please visit .
GP Singh
SHINKEI Therapeutics
+1 855-574-4653
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