Cyrenaic announces results of CYR-101 Phase IIa clinical trial for schizophrenia

Cyrenaic Pharmaceuticals Inc. ("Cyrenaic"), a private drug development company focused on the treatment of CNS disorders, today announced Phase IIa clinical results for CYR-101, its novel investigational drug for the treatment of schizophrenia. The results from the study showed that the drug alleviated the symptoms of the disease, including the negative and cognitive symptoms.

“We are very encouraged by the results of this study. We believe CYR-101 has the potential to deal with the important aspects of schizophrenia, including those symptoms currently not managed by existing therapies.”

Schizophrenia affects approximately 1% of the general population and is characterized by three major symptom classes: positive symptoms, such as hallucinations and delusions; negative symptoms, such as apathy and emotional flattening; and cognitive symptoms, including impaired memory and attention deficit. Most patients experience some degree of cognitive symptoms during the course of their disease, even during the prodromal phase. Furthermore, if left untreated negative symptoms often lead to poor patient compliance with existing medications and poor control of disease burden.

Whilst existing medications primarily target positive symptoms but have no direct efficacy on other symptoms of this disease, there are currently no approved treatments for the specific treatment of negative or cognitive symptoms. A treatment for these symptoms therefore remains a major unmet medical need in schizophrenia. Despite these shortcomings, the global market for existing antipsychotics was estimated at $16 billion in 2008.

Commenting on the Phase IIa study results, Geoff Race, Strategic Advisor to Cyrenaic, said: "We are very encouraged by the results of this study. We believe CYR-101 has the potential to deal with the important aspects of schizophrenia, including those symptoms currently not managed by existing therapies.

"These results confirm the promising efficacy signal that was observed in relevant animal models and open the door to treatment alternatives not only in schizophrenia but also in a number of other debilitating neurological and psychiatric diseases, suggesting a large spectrum of additional potential indications for CYR-101".

The double-blind, randomized, placebo-controlled, multicentre study was conducted in Europe in 100 patients diagnosed with schizophrenia or schizoaffective disorders as defined in the Diagnostic and Statistical Manual of Mental Disorders (Edition IV-TR). The most salient result observed after treatment with CYR-101 was a reduction of negative symptoms as measured by the Positive and Negative Syndrome Scale (PANSS) compared to placebo. CYR-101 also improved cognition as measured by the Brief Assessment of Cognition in Schizophrenia instrument (BACS). Confirming the benign safety profile observed in four previously completed Phase I clinical studies, CYR-101 was well tolerated with no evidence of the side-effects associated with typical and atypical antipsychotics, including weight gain, prolactin increase and extrapyramidal symptoms.

Cyrenaic's CYR-101 studies have been conducted by Forenap Pharma, an international leader in the field of neuroscience and psychiatric clinical trials.