First Five Subjects Randomized in SyneuRx’ SND12 Phase IIb/III Study of Clozaben®, a Novel Treatment for Refractory Schizophrenia

　　SyneuRx International (Taiwan) Corp. today announced that the first five subjects have been randomized for the company’s SND12 Phase IIb/III clinical trial. The trial will study the efficacy and safety of one of its leading investigational therapies, Clozaben®, for adult subjects with schizophrenia who are refractory to current treatments available.
　　Clozaben® is an investigational first-in-class D-amino acid oxidase inhibitor in combination with clozapine.  Clozapine is the last line of treatment for those patients who had failed all the other possible antipsychotic treatments, a group of patients called refractory schizophrenia. An estimated 30% or more of people with schizophrenia are refractory to treatment. The substantial risk and insufficient efficacy of antipsychotics for refractory schizophrenia points to an urgent need to develop therapy to prevent and/or mitigate psychotic symptoms, functional deficits, and debilitating side effects in these patients.
　　The clinical study is expected to enroll about 287 subjects from up to 40 different centers in the U.S, Canada, and Europe for an 8-week double-blind treatment phase. The safety of long-term treatment of Clozaben® will be supported by the 52-week open-label study in a related trial – SND13, which was also launched recently.
This study was granted by the US FDA with both Orphan Drug Designation (ODD) and Breakthrough Therapy Designation (BTD). The ODD provides seven years of market exclusivity upon drug approval. BTD in CNS indications are very rare. The BTD underscores refractory schizophrenia as a serious condition with limited treatment options, and recognizes Clozaben® as a potential therapy being substantially better than current therapies as shown in preliminary clinical studies.
　　With the ODD and BTD, the US FDA will provide additional support and guidance to a quicker development path toward the new drug approval.
　　“Refractory schizophrenia is like cancer in advanced stages where there are no good treatment options. Existing pharmacotherapies for refractory schizophrenia have limited efficacy and there is only one choice: clozapine. Clozaben®, presents a new, patient-centered treatment approach for people with refractory schizophrenia, to improve the positive symptoms of hallucination and delusion and bring up the much needed social skills and cognitions in order to improve their overall daily functioning at work and/or home. If developed successfully, it is likely to quickly become the leading treatment option for refractory schizophrenia” said the CEO and Chairman of SyneuRx International (Taiwan) Corp, Emil Tsai, MD, PhD, MAS.
About SND12 study
　　To learn more about the SND12 study, please click http://syneurxtrials.com/Trials/Adult-Schizophrenia for more information about study and recruitment.
About SyneuRx International (Taiwan) Corp.
　　SyneuRx (6575) is a global biotech company listed at the Emerging Board of Taiwan. The company specializes in the development of new-class drug therapies for CNS disorders. Several programs are currently in progress in late-phase clinical trials or are late-phase clinical trials ready.  The indications include major CNS disorders such as schizophrenia, dementia, and depression.
Disclaimer:
　　This is not an invitation to invest in or acquire SyneuRx (6575TT) stocks.  Statements made in this news release that are not historical facts, including statements concerning future clinical trials, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  Words such as “expect,” “believe,” “intend,” “design,” “plan,” “continue,” “may,” “will,” “anticipate,” and similar expressions are intended to identify forward-looking statements.  Actual results may differ materially from those projected in any forward-looking statement.  Specifically, there are a number of important factors that could cause actual results to differ materially from those anticipated, such as risks and uncertainties related to the actions and decisions of Taipei Exchange, the Company’s ongoing ability to raise additional capital, risks related to the Company’s ability to enroll patients in its clinical trials and complete the trials on a timely basis, uncertainties about the clinical trials process, uncertainties about the timely performance of third parties, risks related to whether the Company’s products will demonstrate safety and efficacy, risks related to the Company’s ability to carry out the intended manufacturing and expansions and risks related to the Company’s ability to carry out the Hospital Exemption program and risks related to possible reimbursement and pricing.  Finally, there may be other factors not mentioned above or included in the Company’s filings that may cause actual results to differ materially from those projected in any forward-looking statement.  You should not place undue reliance on any forward-looking statements.  The Company assumes no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by securities laws in Taiwan.
 
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