Keep It Quick Reviews

[PoemStone]

INFO & comment on ACAD. [umiak].
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=78288137

ACAD--added today--a little DD:

Sent: Wednesday, June 27, 2012 2:17 PM
Subject: ACAD

Follow the money:
eoq Q1:
cash 26M eoy 31M
burn rate 5M per q
cash through q213
They have plenty of money to complete trial, looks like good overall money management.
Good pipeline, anti-psychotics don't work well for PDP so this would be first choice if they can pass FDA.

Pimavanserin for Parkinson’s disease p3 due Nov '12

Will they succeed?


Quote:
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This Phase III trial builds on the signals of efficacy observed in our earlier PDP studies and uses a refined study design that we expect will help mitigate the placebo response, reduce variability and enhance sensitivity in measuring the efficacy of pimavanserin in PDP patients, said Uli Hacksell, Ph.D., Chief Executive Officer of ACADIA Pharmaceuticals. We believe pimavanserin has an ideal profile to effectively treat PDP without impairing motor function and, therefore, provides the potential for an important advance in therapy for patients suffering from this large unmet medical need.
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How did ACAD go about creating a better trail?
1) The 40 mg showed the most promise of the 2 in the 2009 study so they got rid of the 10mg.
2)They limited the number of visits from study staff to participating patients. The first trial failed in part due to the unexpected improvement in placebo patients. The logic is first study showed improvement in placebo group due to increased quality of care.
3)They limited patients to US only, first trial was in 7 different countries. Again, continuity of care.
.......here are 2 other tweaks to the first study from another source, link follows as it is a good article:

Quote:
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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
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http://a6research.blogspot.com/2012/07/a-promising-drug-on-horizon-acadia.html

What about the failed 2009 p3? From the website:
In September 2009, we announced top-line results from an initial Phase III PDP trial (-012 Study). While the
-012 Study was impacted by a larger than expected placebo response and did not meet its primary endpoint, signals of antipsychotic efficacy were consistently observed in the 40 mg pimavanserin arm. These signals were most prominent in the United States portion of the study, which comprised nearly one-half of the patients in the study. The -012 Study met the key secondary endpoint of motoric tolerability and pimavanserin was generally safe and well tolerated in the study.



Quote:
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What do we know about 5-HT2A
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Pimavanserin selectively blocks the activity of the 5-HT2A receptor, which plays an important role in psychosis.

A little something I found in a random search for 5-HT2A...
Quote:
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Hallucinogens Recruit Specific Cortical 5-HT2A Receptor-Mediated Signaling Pathways to Affect Behavior
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(could be all hallucinations follow this pathway, however they are induced, so blocking 5-HT2A receptor makes sense)