ACADIA (NASDAQ: ACAD) announced the completion of enrollment in its ongoing pivotal Phase III
trial with pimavanserin in patients with Parkinson’s disease psychosis
(PDP). Top-line results from this trial are expected to be announced by
the end of November 2012.
Reasons
why I think the Phase III (-020) trial will be successful:
- The trial will test only 40mg pimavanserin vs. placebo in a 1:1 randomization compared to 3 arms in the previous phase failed trial. It should help reduce the statistical complexity
- This trial also has two-week lead-in period which include social therapy in order to help pull initial placebo responses ahead of the assessment period. This will help rule out placebo effect
- The trial has new Scale for the Assessment of Positive Symptoms (SAPS) endpoint through analysis of the two previous trials -012 and -014. The new trial will focus on 9 items compared to 20 items in previous failed trials. The SAPS endpoint was accepted by the FDA
- Most importantly, this trial will enroll a more homogeneous patient population (US patient population ONLY). The previous failed trial enrolled patients in seven different countries (U.S., U.K., France, Bulgaria, India, Russia, and Ukraine)
Since now we have a clear timeline of the phase III data release. This poses a great near term opportunity for us to take a stock position. I feel as we get near end of October and early November, we will see good number of press releases about this drug. I can see this stock trading near $2.00 to $2.20 range as we get near the data release and once day trader starts scanning this stock. I also feel the that data will be positive due to very careful modification of clinical trial.
I was surprised to see ACADIA (NASDAQ:ACAD) hold its 1.80 support all day today (September 5th, 2012). Normally, small biotech companies like this tend to sell off after a news release. This can be a positive for this stock. Once again, this drug has a unique mechanism of action and has an unmet need.
Pimvanserin
Pimavanserin is a new chemical entity that can be
taken orally as a tablet once-a-day. Pimavanserin selectively blocks the
activity of the 5-HT2A receptor, a drug target that plays an important role in
psychosis.
Parkinson’s
disease psychosis, or PDP, is a debilitating disorder that develops in up to 60
percent of patients with Parkinson’s disease. PDP is characterized by the
presence of hallucinations and delusions.
Disclosure: May initiate position in next 72 hours
Resources: Reuters, Acadia
Pharmaceutical Investor Relations, Google Images, Journal of Clinical
Psychiatry, Abilify Package Insert
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