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Cyrenaic Pharmaceuticals Reports Improvement of Negative Symptoms and Cognition in Schizophrenia Patients Treated with CYR-101

Data suggest the drug could address the most important unmet medical need in schizophrenia

PRINCETON, N.J.--(BUSINESS WIRE)--Nov 30, 2010 - 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.

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.


About Cyrenaic Pharmaceuticals
Cyrenaic is focused on the development of CYR-101, an innovative antipsychotic in development for the treatment of schizophrenia that has the potential to treat all symptoms of the disease. The Company was established through a joint investment by Care Capital and Index Ventures in 2007. Cyrenaic is headquartered in Princeton, New Jersey, USA. Cyrenaic's clinical studies are being conducted by French neuroscience CRO Forenap Pharma based in Rouffach, France.

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About CYR-101
CYR-101 is a small molecule New Molecular Entity with a novel mechanism of action that was in-licensed from a leading Japanese pharmaceutical firm. It shows potent antagonistic effects at 5-HT2A and sigma-2 receptors in vivo and in vitro and is devoid of direct modulatory activity on dopamine transmission.

About schizophrenia
Schizophrenia is a chronic, severe and disabling mental disorder affecting 2.4 million Americans (approx. 1.1% of the U.S adult population) and approximately 5 million people globally. While there is no cure for the disease, correct medication and treatment is able to keep the disorder in check. According to Datamonitor, the global schizophrenia market was valued at US$16 billion in 2008. The symptoms of schizophrenia are broadly categorized as positive, negative, and cognitive symptoms. Positive symptoms are psychotic behaviors not seen in healthy people, such as hallucinations and delusions. Negative symptoms are associated with disruption to normal behavior and emotion, such as a lack of ability to sustain planned activity or a lack of pleasure in everyday life. Cognitive symptoms include problems with working memory and trouble focusing or paying attention.


Contact: Media enquiries
College Hill Life Sciences
Nicole Yost and Jayne Crook
Ph: +44 (0)20 7866 7855
Corporate enquiries
Geoff Race
Ph: (+44) 7968 961 275
US: Care Capital – Dr. Lorenzo Pellegrini
Ph: (+1) 609-683-8300
Europe: Index Ventures – Dr. Michele Ollier
Ph: +41 (0)22 737 00 00



Posted: November 2010