Profile: ACADIA Pharmaceuticals Inc (ACAD.O)
27 Nov 2015
ACADIA Pharmaceuticals Inc., incorporated on January 16, 1997, is a biopharmaceutical company. The Company is focused on the development and commercialization of medicines for the treatment of neurological and related central nervous system disorders. The Company’s drug candidate NUPLAZID (pimavanserin) is under development for the treatment of Parkinson’s disease psychosis, Alzheimer’s disease psychosis, Schizophrenia and Sleep disturbances. The Company is also conducting preclinical programs for alpha adrenergic agonists indicated for the treatment of chronic pain and muscarinic drugs for the treatment of glaucoma.
NUPLAZID has an active ingredient pimavanserin, is a selective serotonin inverse agonist (SSIA) preferentially targeting 5-HT2A receptors that was discovered by the Company and under development for the treatment of psychosis. NUPLAZID is being developed for the treatment of Parkinson’s disease psychosis, Alzheimer’s disease psychosis, Schizophrenia and Sleep disturbances. The Company has completed a pivotal Phase III clinical trial, referred to as the -020 Study, evaluating the efficacy, tolerability, and safety of NUPLAZID in patients with Parkinson’s disease psychosis (PDP). The -020 Study was a multi-center, double-blind, placebo-controlled clinical trial. A total of 199 patients were enrolled in the study and randomized on a one-to-one basis to receive either 34 milligrams (mg) of NUPLAZID (the equivalent of 40mg of pimavanserin tartrate) or placebo once-daily for six weeks, following a two-week screening period that included brief psycho-social therapy. Patients also received stable doses of their existing anti-Parkinson’s therapy throughout the study. NUPLAZID met the primary endpoint in the -020 Study by demonstrating a highly significant reduction in psychosis (p=0.001) as measured using the SAPS-PD, a scale consisting of nine items from the hallucinations and delusions domains of the Scale for the Assessment of Positive Symptoms. NUPLAZID also met the key secondary endpoint for motoric tolerability as measured using Parts II and III of the Unified Parkinson’s Disease Rating Scale, or UPDRS. These results were further supported by highly significant improvements in all secondary efficacy measures, including the Clinical Global Impression Severity, or CGI-S, scale (p<0.001), the Clinical Global Impression Improvement, or CGI-I, scale (p=0.001), and a CGI-I responder analyses (p=0.002). The United States Food and Drug Administration (FDA) granted Breakthrough Therapy designation for NUPLAZID for the treatment of Parkinson’s disease psychosis. NUPLAZID was safe and well tolerated in the Phase III trial. The Company is also conducting an open-label safety extension study, referred to as the -015 Study, involving patients with Parkinson’s disease psychosis who have completed the -020 Study and its earlier Phase III studies. A total of over 250 patients have been treated with NUPLAZID for at least one year, and of those at least 100 patients have been treated for at least two years. The Company’s longest single-patient exposure is greater than nine years.
The Company is conducting a Phase II study exploring the utility of pimavanserin for the treatment of Alzheimer’s disease psychosis (ADP). The Phase II trial also referred to as the -019 Study, examines the efficacy and safety of pimavanserin as a treatment for Alzheimer’s disease psychosis. The -019 Study is a randomized, double-blind, placebo-controlled study designed to enroll 200 patients with Alzheimer’s disease psychosis. Following a screening period that includes brief psycho-social therapy, patients are randomized on a one-to-one basis to receive either 34 milligrams (mg) of pimavanserin (the equivalent of 40mg of pimavanserin tartrate) or placebo once-daily for twelve weeks. The -019 study will assess several key efficacy endpoints, including use of the Neuropsychiatric Inventory-Nursing Home scale to measure psychosis and other behavioral disorders. Key efficacy endpoints will be based on the change at week 6 from baseline. The study will also assess additional exploratory endpoints, including the cognitive status of patients and the durability of response to pimavanserin, through twelve weeks of therapy.
The Company has completed a Phase II study of pimavanserin as a co-therapy (risperidone) in patients with schizophrenia. The trial results showed several advantages of co-therapy with pimavanserin and a 2 millligram, or low, dose of risperidone in patients with schizophrenia. These advantages included efficacy comparable to that of a 6 milligram, or standard, dose of risperidone, combined with a faster onset of antipsychotic action and an improved side effect profile, including significantly less weight gain, compared to the standard dose of risperidone.
Clinical benefits of pimavanserin were observed in an exploratory efficacy measure of sleep during the Company’s -020 Study. Pimavanserin has shown benefits in nighttime sleep and daytime wakefulness in studies conducted in elderly patients with PDP. Sleep was assessed using the SCOPA-sleep scale, which was designed to evaluate nighttime sleep and daytime wakefulness.
Alpha Adrenergic Program
The Company in collaboration with Allergan, has discovered small-molecule product candidates for the treatment of chronic pain. Its alpha adrenergic agonists are designed to provide pain relief without the side effects of current pain therapies, including sedation and cardiovascular and respiratory effects. Allergan has conducted several Phase II trials in this program, and has reported preliminary results, including positive proof-of-concept in a visceral pain trial in patients who had hypersensitivity of the esophagus, and efficacy signals in two chronic pain trials in the areas of fibromyalgia and irritable bowel syndrome.
The Company has discovered and, in collaboration with Allergan, are developing small-molecule product candidates for the treatment of glaucoma. Using its discovery platform, the Company identified a subtype of the muscarinic receptors that controls intraocular pressure and discovered lead compounds that selectively activate this target. In preclinical models, its product candidates have demonstrated a promising preclinical profile, including robust efficacy and a long duration of action. This program has reached Phase I development.
The Company competes with Astra-Zeneca PLC, Sunovion Pharmaceuticals Inc., Eli Lilly and Company, Johnson & Johnson, Bristol-Myers Squibb Company, Otsuka Pharmaceutical Co., Ltd., Pfizer Inc., Allergan, Eisai Inc. and Forest Laboratories, LLC.
ACADIA Pharmaceuticals Inc
3611 Valley Centre Dr Ste 300
SAN DIEGO CA 92130-3331