June 26, 2007

New Clozapine-like Medication Entering Phase II Clinical Trials

Acadia Pharmaceuticals has announced today that phase II clinical trials for its new schizophrenia medication under development has begun.

New medications that are still in development are given a number to identify them, until they get to the point where they prove that they work well enough to pass the FDA tests and will be commercialized. Accordingly, this new Clozapine-like drug is for now simply called "ACP-104".

ACP-104 is actually a chemical called N-desmethylclozapine, a major metabolite of clozapine (trade name Clorazil). Its development, which has been supported in part by the Stanley Medical Research Center, is designed to provide an atypical antipsychotic level of effectiveness with the added potential benefit of enhanced thinking ability, or cognition.

If you're interested in contacting the company to learn more about this clinical trial or to potentially participate in the testing of this new medication, you can visit the Acadia Pharma web site contact information page here. We would recommend you talk to your doctor about this before you consider participating in the test, or make any medications changes.

As with any new medication development effort, there is no guarantee that this product will be any better than any existing medication. That is what these clinical trials hope to determine.

At a recent biotechnology conference, and Acadia executive had this to say about this new mediation program:

You can see the co-therapy group here in purple and what this shows is after only two weeks of therapy, more than 60% of the patients in the co-therapy arm responded to the treatment, which was significantly greater than either the low dose or the high dose of risperidone.

We believe this provides a significant advantage for the therapy because it's coming at a time in a treatment when the patients are typically hospitalized and undergoing the most expensive part of their medical care. We therefore think this may translate to health economic benefits. In addition to efficacy advantages, we also saw advantages in a side effect profile with pimavanserin therapy.

On the left you see that the co-therapy provided significantly lower prolactin levels as compared to a high dose of risperidone. And on the right, you see that the co-therapy also resulted in 50% lower weight gain than the standard dose of risperidone. Both elevated prolactin and weight gain are troubling side effects of many antipsychotic drugs.

In total, we are very excited with the results of this study which showed the key advantages of pimavanserin co-therapy and the benefits it provides the schizophrenia patients. Following the top-line results, we've been busy conducting the full analysis of the trial, and I'm pleased to report today that this has progressed very well and we're nicely on track to complete this analysis this month in June.

We do continue to plan to present the full data set from this trial at a medical meeting in the second half of this year, and importantly we feel with the conclusion of the full analysis, we're well positioned to begin to explore strategic alliances in this program.

Below is the press / marketing release from the company:

ACADIA Pharmaceuticals Initiates Phase IIb Clinical Trial with ACP-104 in Patients with Schizophrenia

ACADIA Pharmaceuticals Inc., a biopharmaceutical company utilizing innovative technology to fuel drug discovery and clinical development of novel treatments for central nervous system disorders, today announced the initiation of a Phase IIb clinical trial designed to evaluate the safety and efficacy of ACP-104 as a treatment for patients with schizophrenia.

“ACP-104 represents a promising new approach to the treatment of schizophrenia that combines the potential for a superior atypical antipsychotic efficacy profile with enhanced cognition, thereby addressing the major challenges in schizophrenia therapy today,” said Uli Hacksell, Ph.D., Chief Executive Officer of ACADIA. “The initiation of this Phase IIb trial with ACP-104, along with our clinical program with pimavanserin as a co-therapy for schizophrenia, underscores ACADIA’s ongoing commitment to improve the standard of care for patients who suffer from this debilitating mental illness.”

The Phase IIb trial is a multi-center, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of ACP-104 in approximately 250 patients with schizophrenia who are experiencing an acute psychotic episode. Patients in the trial will be randomized to three different study arms, which will include two different doses of ACP-104 (100 mg twice daily and 200 mg twice daily) and one placebo arm. Patients will receive oral doses of either ACP-104 or placebo for six weeks. The primary endpoint of the trial is antipsychotic efficacy as measured using the Positive and Negative Syndrome Scale, or PANSS, an industry standard rating scale commonly used in schizophrenia trials.

About ACP-104

ACP-104, or N-desmethylclozapine, is the major metabolite of clozapine that ACADIA is developing as a novel stand-alone therapy for schizophrenia. ACP-104 is designed to provide an atypical antipsychotic efficacy profile with the added potential benefit of enhanced cognition. ACP-104 combines M1 muscarinic agonism, 5-HT2A inverse agonism, and D2 and D3 dopamine partial agonism in a single compound and, therefore, uniquely addresses what ACADIA believes are the three most promising target mechanisms for treating schizophrenia. In 2006, ACADIA announced results from three initial studies with ACP-104 in patients with schizophrenia. The results of these studies demonstrated that initial signals of antipsychotic effects were observed within the tolerated dose range of ACP-104 after treatment of up to two weeks. ACADIA’s development program for ACP-104 has been supported in part by the Stanley Medical Research Center.

About ACADIA Pharmaceuticals

ACADIA is a biopharmaceutical company. ACADIA’s corporate headquarters is located in San Diego, California and it maintains research and development operations in both San Diego and Malmö, Sweden. For more information see: Acadia Pharmaceuticals web site.

Related News:
Acadia Pharma Talks about its New Schizophrenia Medications in Development
ACP-104 Future Schizophrenia Drug?
Acadia Pharma CEO Speech
New Research to Improve Schizophrenia Cognition


Anyone heard anything on when any new antipsychotics will be released or FDA approved?

Posted by: Cory Schulz at June 26, 2007 09:40 PM

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