SyneuRx International (Taiwan) Corp. today announced that the first three subjects have been randomized from the 11 subjects screened into the company’s SND13 Phase IIb/III clinical trial within a short period of time. The trial will study the efficacy and safety of its leading investigational therapy NaBen© for adult subjects between 18 and 55 years of age with schizophrenia.
NaBen© (1000 mg daily) is an investigational first-in-class D-amino acid oxidase inhibitor. It can be used as an add-on treatment to any existing drug therapies. NaBen© addresses comprehensive symptom domains. It aims at improving negative symptoms such as social withdrawal, lack of motivation and cognitive symptoms including concentration and memory. Neither of these domains has existing treatments yet. At the same time, NaBen© was shown to be able to supplement existing therapies on reducing positive symptoms (hallucinations, delusions, and suspiciousness) as well.
The clinical study is expected to enroll about 348 subjects from up to 40 different centers in the U.S, Canada, and Europe for a 12-week double-blind treatment phase, followed by a 52-week open-label extension phase.
This study was approved by US FDA with Breakthrough Therapy Designation (BTD). Breakthrough designations in CNS indications are very rare. The BTD underscores schizophrenia as a serious condition with limited treatment options, and recognizes NaBen© as a potential therapy being substantially better than current therapies as shown in preliminary clinical studies.
With the BTD, the US FDA will provide additional support and guidance to a quicker path to a NDA application.
“Existing pharmacotherapies for schizophrenia is limited in their efficacy. Our SND13 study presents a new, patient-centered treatment approach for schizophrenia patients, to bring up the much needed social skills and cognitions in order to improve patients’ overall daily functioning at work and/or home” said the CEO and Chairman of SyneuRx International (Taiwan) Corp, Emil Tsai, MD, PhD, MAS.
About SND13 study
To learn more about the SND13 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 late-phase clinical trials ready in major CNS conditions including schizophrenia, dementia, and depression.