A low dose of ACP-103 and either risperidone, an atypical antipsychotic, or haloperidol, a typical antipsychotic, produced the same results as high doses of the other drugs. At high doses, both risperidone and haloperidol are associated with side effects. In a conference call with analysts, Acadia officials said they expect the ACP-103 combinations to be easier on patients. In particular, they said that an ACP-103 combination with risperidone caused only half the weight gain of a high dose of risperidone in the same time span.
Acadia also pointed out that the ACP-103 regimens achieved much of their efficacy within 2 weeks, while the other drugs, working alone, needed three to four weeks to get a similar effect. This is the time during which patients are hospitalized, raising the hope that ACP-103 could be cost-effective by getting patients home more quickly.
In the conference call, Uli Hacksell, PhD, CEO of Acadia, said the company would first analyze the data more thoroughly, then seek to find a partner for the drug before entering Phase III trials. He said a big consideration in seeking a partner was to find one with “marketing muscle” in anti-psychotics so that Arcadia could compete with the powerful drug companies who are already in that space.
To analyze the effectiveness of the drug, Acadia used the Positive and Negative Syndrome Scale [PANSS] as the primary endpoint of the trial, which lasted for six weeks. In the risperidone side of the trial, a low dose of risperidone (2 mg) and 20 mg of ACP-103 reduced symptoms by 27.4%. These results were about the same as a high dose of risperidone, which produced a 26.4% reduction. In comparison, a low dose of risperidone by itself lowered symptoms by only 19%.
The results were less positive when the Acadia drug was used with haloperidol. In this arm, ACP-103 did not provide a statistically significant improvement, though, once again, the onset of relief was quicker with the Acadia drug. Acadia expects to begin a Phase III test of ACP-103 for Parkinson’s disease psychosis soon. The compound is the lead drug for Acadia.
At the end of 2006, Acadia had $83.3 million in cash. It burned $41.1 million during 2006, but raised $59.4 million in a secondary offering last year. With its big increase in share price, Acadia now has a market capitalization of $390 million.
ACAD 1-yr chart