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Acadia Pharmaceuticals (ACAD) Due Diligence (11-17-2012)

About ClinicalTrials:

ClinicalTrials.gov is a Web-based resource that provides patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions.

More information: http://clinicaltrials.gov/ct2/about-studies/learn

Acadia Drug: Pimavanserin (ACP-103)

Completed Phase II Trial (2006) –

Trial: http://clinicaltrials.gov/ct2/show/NCT00087542

Result:  The trial met the primary endpoint, which was to demonstrate that administration of pimavanserin did not result in deterioration of the motoric function of these patients as measured by the UPDRS. Pimavanserin also showed antipsychotic effects in secondary endpoints using two different rating scales, including SAPS. Pimavanserin was generally safe and well tolerated in the study.

Safety (-010 Study): http://clinicaltrials.gov/ct2/show/NCT01518309

Result: On-going PII safety study that will continue until pimavanserin gains FDA approval/hit the market or 8 years have passed.

Completed Phase III Trials (2009+) –

1st attempt – Safety and Efficacy (-012 Study: 10mg vs 40 mg vs Placebo) – http://clinicaltrials.gov/ct/show/NCT00477672

Result: Worldwide Test. Failed due to unusually high placebo response, but signals of antipsychotic efficacy were consistently observed in the pimavanserin 40 mg study arm. The drug was safe and well tolerated.

2nd attempt – Safety and Efficacy (-014 Study: 10mg vs 20 mg vs Placebo) http://clinicaltrials.gov/ct2/show/NCT00658567

Result: U.S. only test. Discontinued early to analyze results. 20 mg pimavanserin arm showed a signal of efficacy on the primary assessment scale and a statistically significant difference from placebo on a secondary outcome measure. The drug was safe and well tolerated.

Safety and Tolerability (-015 Study: Continued safety testing from PIII patients & will continue into -020 study): http://clinicaltrials.gov/ct2/show/NCT00550238

Result: 90% of patients continued enrollment in safety study & continue to receive pimavanserin based on physician recommendation (if improvement was being shown).

Current PIII Trial –

Safety and Efficacy (Study -020: 40mg vs Placebo) – http://clinicaltrials.gov/ct2/show/NCT01174004

Pimavanserin Patents –

10 U.S. Patents & 50 International Patents.

U.S. Patents protect drug from being reproduced generically until 2021. Other pimavanserin/pyschosis specific patents cover the drug until 2028.

Pimavanserin – What’s It Worth?

http://propthink.com/acadias-value-heavily-dependent-on-pimavanserin-data/3357

http://www.strengthforcaring.com/util/press/news/article.html?id=26

Chances of positive PIII (Study -020) results?

I believe this chart (by Zacks Small Cap Research, Sell-Side Equity Research Analyst, Jason Napodano, CFA) provides the best outlook of the chances:  http://4.bp.blogspot.com/-xjp_h_fvPpc/TxolEBJtWmI/AAAAAAAAAes/ecacG-YMuTE/s400/screen-capture-1.png

The data shown above was for 54 patients with an Neuropsychiatric Inventory (NPI) greater than 6 at baseline. These are considered “severely afflicted” patients with Parkinson’s disease psychosis. Results for these 54 patients was of superior statistical significance to the entire 123 U.S. patients using only the 9-SAPS with varied NPI between that was considered “mild to severe.”

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