April 25, 2017
By Mark Terry, BioSpace.com Breaking News Staff
Alzheimer’s disease remains an elusive target for drug manufacturers. Approximately 99 percent of drug trials for the disease have failed, including high-profile failures like Pfizer and Johnson & Johnson ‘s bapineuzumab and Eli Lilly ’s solanezumab. A lot of attention is being paid to an upcoming trial data release of Axovant Sciences ’ intepirdine in September.
Both J&J and Lilly’s drugs were designed to clear amyloid plaques. Intepirdine is a 5-HT6 inhibitor, which increases the release of acetylcholine in the brain. Biogen ’s much-watched aducanumab, currently in Phase III trials, also focuses on amyloid plaques.
David Liang, writing for The Motley Fool, takes a look at Acadia Pharmaceuticals , which is trying a different approach.
Acadia’s lead product is Nuplazid, which is being evaluated for Alzheimer’s disease psychosis (ADP). It has already been approved for Parkinson’s disease psychosis (PDP). ADP is a bigger market, with 25 to 50 percent of Alzheimer’s patients developing ADP, and 5.4 million people already diagnosed in the U.S. with Alzheimer’s.
Liang writes, “Should Nuplazid succeed in Phase III studies for ADP, assuming annual pricing remains similar to PDP, Acadia would be targeting a total addressable market of between $32 billion and $65 billion.”
On December 20, 2016, Acadia released positive top-line results from its Phase II study of Nuplazid in ADP. The drug met the primary endpoints, showing a statistically significant cut in psychosis compared to placebo. The company plans to start Phase III trials in the second half of this year. It is also studying Nuplazid as a treatment for Alzheimer’s disease agitation, and as adjunctive therapy for schizophrenia and major depressive disorder.
Liang writes, “While Nuplazid has multiple large shots-on-goal, this stock is definitely not for the faint-of-heart. As I have pointed out before, while Nuplazid did succeed in its Phase II study as treatment for ADP, this study was not without its controversies. Namely, while the results were significant, they were barely so, with Nuplazid beating placebo at a p-value of .0451 (for reference, the cutoff for p-values is .06, and the closer to ‘0’ the better).”
Liang notes that it’s really too early to know how the drug is trending. It was launched in PDP in May 2016, and seems to be doing fairly well. Will it for other indications? Way too early to tell.
And it’s a bit of a stretch to describe the drug as a treatment for Alzheimer’s disease, although it may be possible to treat one component of the disease.
Acadia is currently trading for $35.97. It’s been a fairly volatile stock. Shares traded on June 8, 2016 for $41.55, dropped to $22 on Nov. 2, 2016, rose to $39.47 on Feb. 15, 2017, and back to $32.36 on April 7.
At the company’s fourth-quarter financial update, it reported total revenues (and product sales) of $11.96 million for the fourth quarter and yearly totals of $17.331 million for total revenues and $17.327 million of net product sales.
“2016 was a transformational year for Acadia highlighted by the launch of Nuplazid (pimavanserin) as the first and only drug approved by the FDA for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis,” said Steve Davis, Acadia’s president and chief executive officer, in a statement. “We are pleased with the strong progress of the launch and our execution in bringing this drug to Parkinson’s patients.”
