Thursday, September 19, 2019

Thursday, September 19, 2019

SHINKEI THERAPEUTICS: FDA Accepts SHINKEI Therapeutics Investigational New Drug Application for MR-301 for Traumatic Brain Injury


SHINKEI Therapeutics issued the following announcement on Aug. 28.

SHINKEI Therapeutics., a clinical stage pharmaceutical company focused on the development of therapeutic drugs for the treatment of Central Nervous System (CNS) disorders, today announced that they received notification from Food and Drug Administration (FDA), stating that FDA has accepted the filing of an Investigational New Drug (“IND”) application for MR-301 for the treatment of Severe Traumatic Brain Injury (sTBI) resulting in minimally conscious and/or vegetative comatose state.

There is no approved medication that can be administered to reverse the effects of sTBI and improve cognitive functions of the patient. Every year, 80,000-90,000 people experience the onset of long-term or lifelong disabilities associated with sTBI. We look forward to examining the potential of MR-301 to treat this distressing condition. The filing and FDA clearance of this IND is a key milestone and we are now able to move forward with our clinical program. We expect the dosing on the initial study in healthy volunteers to start in next 30 days continuing the progress towards development and approval of MR-301 using the 505(b)(2) pathway.

About SHINKEI Therapeutics

SHINKEI Therapeutics is a CNS (Central Nervous System) disorders focused pharmaceutical company using the 505(b)(2) regulatory strategy to repurpose existing pharmaceutical products for faster and better patient outcome. The pharmaceutical industry has over last few years largely neglected investing in the development of drugs for many CNS disorders. With reduced R&D spending and a need to boost productivity in finding new products, pharma increasingly relies on new concepts from partners like SHINKEI who are on the front lines of identifying unmet clinical needs. For more information, please visit www.SHINKEITherapeutics.com.

Original source can be found here.

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