The return to the therapy angle will continue in July as more breaking news has developed related to my first SharePost in June. I feel the great hope for a medical breakthrough that can halt or reverse the cognitive deficits that people diagnosed with schizophrenia experience warrants immediate attention. I will focus now on just such a contender.
Cypress Bioscience, Inc. has entered into an exclusive North American license for the development and commercial use of BioLine RX's novel antipsychotic, CYP-1020, an agent that has the potential to alleviate cognitive impairment as well as psychotic symptoms.
A six-week double-blind placebo and active-comparator (risperidone) controlled multi-site Phase 2B clinical trial showed that CYP-1020 at the 20-30 mg dose range resulted in clinically relevant and statistically significant improvement in cognition using a test known as the Brief Assessment of Cognition in Schizophrenia (BACS).
The BACS test battery measures aspects of cognition like verbal memory, working memory, motor speed, verbal fluency, attention and speed of information processing, and executive function. As you might know from firsthand experience, people with schizophrenia often experience severe deficits in these areas.
The 20-30 mg/day dose range of CYP-1020 was superior at endpoint to both risperidone and placebo in the BACS total score. This compound also effectively treated other symptoms measured by the Positive and Negative Symptoms Scale (PANSS).
Serious adverse effects were low in the CYP-1020 (20-30 mg/day) patients (0%) in relation to risperidone (3.3%) and placebo (6.5%). Adverse metabolic effects including body weight gain, glucose increases or changes in lipids were not statistically significant either.
An extended trial revealed that those patients who took the CYP-1020 at the 20-30 mg/day dose for six additional weeks after the original study maintained their improvements in the PANSS and continued to show cognitive improvement.
The study was conducted at 40 sites in the U.S. Europe and India under a U.S. Food and Drug Administration investigational New Drug Application (IND). The 363 participants were patients in the throes of acute episodes who were randomized equally to treatment with a low (10 mg/day) or high (20-30 mg/day) dose of CYP-1020, risperidone (2-8 mg/day) or placebo.
As you can see I wanted to report on this breaking news instead of getting back to an evergreen topic because I feel community members need to know about such developments as soon as they occur. What I find hopeful about this study is that it was done on individuals who were actively symptomatic and so the new compound would potentially be used as a first line of defense instead of as a "fail-first" drug used only after another antipsychotic did not work. This could be good news indeed as an alternative to other drugs that have a host of unwanted side effects.
The idea that comes to my mind is that CYP-1020 could level the playing field and enable more people diagnosed with schizophrenia to hold jobs and engage in life in ways that were limited because of their cognitive impairment.
Published On: June 27, 2010