SHINKEI THERAPEUTICS ANNOUNCES INVESTIGATIONAL NEW DRUG APPLICATION SUBMISSION FOR MR-201, A NOVEL DOSAGE FORM FOR TREATMENT OF PSEUDOBULBAR AFFECT

August 21st , 2019

PRINCETON, N.J., August 21st , 2019 -- SHINKEI Therapeutics, a clinical stage pharmaceutical company focused on the development of drugs for the treatment of Central Nervous System (CNS) disorders, today announced the filing of an Investigational New Drug ("IND") application with the U.S. Food and Drug Administration ("FDA") of MR-201, a novel dosage form for the treatment of Pseudobulbar Affect (PBA).
There are limited treatment options available for PBA which affects almost 1.8 million patients in USA. The successful filing of this IND is a key milestone. This submission follows our PIND meeting feedback, preliminary animal studies and a pilot human pharmacokinetic study. The clinical development program for MR-201 will commence with a Phase I study in healthy volunteers. The goals of the study will be to assess the tolerability and steady state pharmacokinetics of MR-201. SHINKEI seeks to leverage existing clinical and nonclinical data in conjunction with sponsor-initiated studies, such as this Phase I study and the previously completed pilot study, to accelerate development and approval of MR-201 via 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.

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 SHINKEI Therapeutics, PICb, 303A College Road East, Princeton, NJ 08540 : 1855 5 SHINKEI 2 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)
[email protected]
www.SHINKEITherapeutics.com