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

Friday, August 30, 2019 Drug News
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(GLOBE NEWSWIRE) - 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 the 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 the 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 the 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

Forward-looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimated,” and “intend,” among others. These forward-looking statements are based on SHINKEI’s current expectations and actual results could differ materially.

There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties with respect to lengthy and expensive clinical trials, that results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or third-party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations.

As with any drug candidates under development, there are significant risks in the development, regulatory approval, and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful, or that any product will receive regulatory approval for any indication or prove to be commercially successful. SHINKEI does not undertake an obligation to update or revise any forward-looking statement.

For further information, please contact:

GP Singh

SHINKEI Investor Relations

303A College Road East

Princeton, NJ 08540 USA

1 855 5 SHINKEI (1 855 5744653)



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