Breakthrough Therapy for Parkinson’s Disease

By Christian Zeron,
Money and Investing Writer

On September 2, the price of Acadia Pharmaceuticals (NASDAQ: ACAD) stock shot up 12 percent. Such rise came as a result of the U.S Food and Drug Administration granting Nuplazid, a compound developed by the San Diego biotechnology company, an impressive designation of ‘Breakthrough Therapy’ in the treatment of Parkinson’s disease psychosis.

Acadia Pharmaceuticals closed with the market on Friday August 29th and $23.98 and upon the positive press release on September 2nd, reopened on Tuesday September 2nd $2.25 higher at $26.23. Since the large increase on September 2nd, Acadia’s stock has risen up to $27.48.

The significance of the Food and Drug Administration’s title ‘Breakthrough Therapy’ is to expedite the development and review of a given treatment that is intended to particularly life-threatening conditions.

Such a designation translates to quicker market breakthrough to investors and in turn a rapid return.

By passing through both Phase I and Phase II Clinical Trials, proving to have no toxic value and effectively function against placebo in a double blind study has landed Nuplazid in Phase III Clinical Trials to ensure final confirmation of safety and efficacy.

Uli Hacksell, Ph.D., Chief Executive Officer of ACADIA stated “NUPLAZID represents a potential new class of psychosis medication and could be the first drug approved in the United States for patients with Parkinson’s disease psychosis.”

Essentially meaning, If proven effective, Nuplazid will be the only therapy to treat Parkinson’s disease psychosis on the United States market and thus without competition.

To elaborate, Nuplazid will not cure Parkinson’s but rather greatly better the quality of life of those living with it. Such improvements in quality of life come by targeting 5-HT2A receptors with inverse selective serotonin and eradicating the common visual hallucinations and delusions that Parkinson’s victims suffer from daily.

Each year, Parkinson’s effects more than 60,000 Americans. As the disease progresses, victims lose their ability to perform simple tasks such writing a letter and eventually are unable to walk.

In addition to the physical limitations Parkinson’s imposes, victims also experience psychological hardship.

Joyce Oberdorf, president and chief executive officer of the National Parkinson Foundation stated “The hallucinations and delusions in Parkinson’s disease psychosis are devastating to patients and contribute to a dramatic rise in caregiver burden.”

Although Nuplazid has progressed furthest in its Parkinson’s indication, it is also being formerly tested for efficacy in Schizophrenia and Alzheimer’s disease in Phase II Clinical Trials.

Annually, Alzheimer’s disease leads to the death of 500,000 people putting it at the 6th leading cause of death in the United States of America. Only 3 percent of Alzheimer’s patients live after 14 years of diagnosis.

Schizophrenia is a severe psychiatric illness that induces multiple personalities in its victims as well as one’s ability to distinguish reality from imagination. While may only officially effect 1.2 percent of the United States population, is expected to effect and go undiagnosed in masses.

As it stands, Nuplazid shows great promise in one, and even possibly three indications but Acadia Pharmaceuticals doesn’t stop there.

Including Nuplazid, Acadia has a wide pipeline with five compounds. These developmental compounds address seven indications. Three of the compounds have entered Clinical Trials while the remaining two remain in the preclinical phase.

Very simply, Acadia Pharmaceuticals has an opportunity to own the sole product in an important market. If Nuplazid passes though Phase III Clinical Trials, Acadia very well may be the next big biotech.

A version of this article appeared in the Tuesday, Sept. 9 print edition.

Contact Christian at

christian.zeron@student.shu.edu

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