Optimistic on Acadia |
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By Jason Napodano, CFA - Zacks Investment Research | |
Tuesday, 26 April 2011 10:53 | |
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Acaida Pharmaceuticals is developing pimavanserin, a potent and selective 5-HT2A inverse agonist, in phase 3 trials for the treatment of Parkinson’s disease psychosis (PDP). Pimavanserin was designed to modulate dopamine transmission by decreasing dopamine release in the brain regions where excessive dopaminergic transmission underlies psychosis, and by increasing dopamine release in brain regions where low levels of dopaminergic activity may cause cognitive deficits. Previous Work In PDP Management has tested the drug in two previous phase 3 trials. High placebo responses, specifically in centers outside the U.S., doomed these two trials (Study-012 and Study-014). However, we think there were clear signs of efficacy in those programs. Below are data read-outs from -012 showing the high placebo response in the global population, and the more consistent data in the U.S., on the primary endpoint of antipsychoitic efficacy assessed by the Scale for the Assessment of Positive Symptoms (SAPS). Management stopped the -014 trial early after -012 failed, even though there was clear separation on both the SAPS and CGII endpoints (below, click to enlarge). Changes in the Current Phase 3 Trial In late July 2010, Acadia initiated a third phase 3 program in PDP (Study-020), this time in the U.S. only. Study-020 is expected to enroll about 200 patients, and will test oral doses of either 40 mg of pimavanserin or placebo once-daily for six weeks in patients with Parkinson's disease. Patients also will continue to receive stable doses of their existing dopamine replacement therapy (DRT) used to manage the motoric symptoms of Parkinson's disease.
The primary endpoint is antipsychotic efficacy as measured using a group of nine items from the hallucinations and delusions domains of the Scale for the Assessment of Positive Symptoms (SAPS), assessed using centralized ratings. Motoric tolerability will be a key secondary endpoint in the trial and will be measured using Parts II and III of the Unified Parkinson's Disease Rating Scale (UPDRS).
The goal of the program is to correct some of the high placebo response witnessed in the two previous phase 3 trials. We note several changes to Study-020 that we believe will aid in the success of the trial.
Acadia continues to conduct an open-label safety extension study (-015) that enrolled patients who completed either of two earlier phase 3 PDP trials. Patients who complete the -020 study will also will have the opportunity to enroll in the -015 if the treating physician agrees the patient will benefit from continued treatment with pimavanserin. Data from Study-020 will be available mid-2012. We note some patients from a previous phase 2 program have been on pimavanserin open-label for nearly five years. We think the safety profile of the drug is outstanding.
We believe the -020 trial and the -015 open label extension study will provide the necessary long-term data required by ICH guidelines for approval of a new chemical entity in this indication. If this trial is successful, we expect Acadia to secure a development and commercialization partnership for pimavanserin that will fund another phase 3 trial in PDP, and potentially new phase 2 and 3 trials with pimavanserin in Alzheimer's disease psychosis and schizophrenia. Cash Position Solid Acadia's cash position is solid. In January 2011, management raised just over $14 million. We estimate the current cash balance is around $45 million. The company also has earlier-stage development programs with Allergan (AGN) for the treatment of glaucoma and neuropathic pain, and with Meiji Seika to develop a new class of pro-cognitive antipsychotic drugs. Acadia is also working on preclinical candidates for Parkinson's disease through a grant from the Michael J. Fox Foundation. Acadia's stock has tripled from December 2010. We believe investors are returning to the story given the improved cash position and increased confidence in the ongoing phase 3 trial. ![]() "Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'. Add this page to your favorite Social Bookmarking websites ![]() ![]() ![]() ![]() ![]() ![]() ![]() ![]() ![]() ![]() ![]() |