ACAD: ACADIA Pharmaceuticals Analysis and Research Report
2018-02-24 - by Asif , Contributing Analyst - 190 views
ACADIA Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system, or CNS, disorders. ACADIA Pharmaceuticals has a portfolio of product opportunities led by its novel drug, NUPLAZID (pimavanserin), which was approved by the U.S. Food and Drug Administration, or FDA, on April 29, 2016 for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis, or PD Psychosis, and is the only drug approved in the United States for this condition. NUPLAZID is a selective serotonin inverse agonist, or SSIA, preferentially targeting 5-HT2A receptors. Through this novel mechanism, NUPLAZID demonstrated significant efficacy in reducing the hallucinations and delusions associated with PD Psychosis in its Phase III pivotal trial and has the potential to avoid many of the debilitating side effects of existing antipsychotics, none of which are approved by the FDA in the treatment of PD Psychosis. The company hold worldwide commercialization rights to pimavanserin. The company launched NUPLAZID in the United States in May 2016.
The company believe that pimavanserin has the potential to address important unmet medical needs in neurological and psychiatric disorders in addition to PD Psychosis and the company plan to continue to study the use of pimavanserin in multiple disease states.
For example, the company believe Alzheimer’s disease represents one of its most important opportunities for further exploration. In December 2016, the company announced positive top-line results from its Phase II study exploring the utility of pimavanserin for the treatment of Alzheimer’s disease psychosis, or AD Psychosis, a disorder for which no drug is currently approved by the FDA. Following its End-of-Phase II Meeting with the FDA and agreement with the agency on its clinical development plan, the company initiated its Phase III HARMONY relapse prevention study in October 2017, which allows it to evaluate pimavanserin for a broader indication than AD Psychosis alone. More specifically, HARMONY will evaluate pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis, which includes psychosis in patients with Alzheimer’s disease, dementia with Lewy bodies, Parkinson’s disease dementia, vascular dementia and frontotemporal dementia. Furthermore, in October 2017, the FDA granted Breakthrough Therapy Designation to pimavanserin for this dementia-related psychosis indication.
As a result of potential overlap of clinical sites and study participants between the HARMONY study and its SERENE study, which is its Phase II study evaluating pimavanserin for the treatment of Alzheimer’s disease agitation and aggression, the company decided to discontinue enrollment of new patients in that study. Patients already enrolled in SERENE will complete the study as planned. The company believe discontinuing enrollment in, and reducing the size of, the SERENE study will enable it to focus external and internal resources on the HARMONY study.
The company also believe schizophrenia represents a disease with multiple unmet or ill-served needs and ACADIA Pharmaceuticals is currently exploring the utility of pimavanserin in this area. Despite a large number of FDA-approved therapies for schizophrenia, current drugs do not adequately address some very important symptoms of schizophrenia, such as the inadequate response to current antipsychotic treatment of psychotic symptoms and negative symptoms. In November 2016, the company announced that the company initiated two studies evaluating the adjunctive use of pimavanserin in patients with schizophrenia. ENHANCE-1 is a Phase III study evaluating pimavanserin for adjunctive treatment of schizophrenia in patients with an inadequate response to their current antipsychotic therapy. ADVANCE is a Phase II study evaluating pimavanserin for adjunctive treatment in patients with negative symptoms of schizophrenia.
Depression is another disorder with a high unmet need that the company believe represents an attractive development opportunity for pimavanserin. Preclinical and clinical studies have shown that patients with depression often do not receive adequate relief from an antidepressant medication and, due to side effects of currently available therapies, many patients discontinue their medication, significantly increasing their chance of relapse. Preclinical and clinical evidence suggests 5-HT2A antagonism may be an effective adjunctive therapy to currently prescribed antidepressants. In December 2016, the company announced that the company initiated CLARITY, a Phase II study evaluating pimavanserin for adjunctive treatment in patients with major depressive disorder, or MDD, who have an inadequate response to standard antidepressant therapy.