Fighting Back Against Parkinson’s
Neurological diseases are insidious and justifiably feared. Among the most dreaded is Parkinson’s disease.
A progressive neurological disorder, Parkinson’s disease is fairly common in older adults. While it can run in families and affect younger people, it most often develops after the age of 50, affecting men and women roughly equally. Nearly 2 percent of those older than age 65 suffer from Parkinson’s.
Symptoms typically begin mildly, with patients initially experiencing a slight tremor, a stiff leg or dragging foot. With time, symptoms include difficulty swallowing or initiating movement, muscle rigidity, worsening tremors and trouble speaking among others.
If the symptoms ended there, the disease would be bad enough. But an estimated 50 percent to 80 percent of patients with Parkinson’s go on to experience Parkinson’s disease dementia (PDD) within 10 years of first being diagnosed with Parkinson’s disease.
PDD results in changes in memory and concentration, difficulty making decisions and interpreting visual information, hallucinations and delusions and, in some cases, violent behavior.
There are no treatments currently available that specifically target PDD, so physicians typically use currently marketed antipsychotic medications or off-label indications to try to minimize symptoms. Unfortunately, many antipsychotic medications block dopamine uptake and worsen the physical symptoms of Parkinson’s.
Acadia Pharmaceuticals (NSDQ: ACAD) has developed a new chemical entity called pimavanserin in trials that could be the answer to those problems.
Last November, the company announced that in a Phase III study, pimavanserin treatment showed strong efficacy in treating PDD and reducing psychotic symptoms without compromising a patient’s motor control.
Tolerability and safety data were also positive, with few side effects compared to a placebo. Pimavanserin also improved nighttime sleep and daytime wakefulness.
The US Food and Drug Administration (FDA) has agreed that the data already collected supports the filing of a new drug application (NDA). Despite that, the company has opted to continue extension trails of two studies to accumulate more long-term safety data on the drug, as well as supportive studies such as those for drug interactions.
At this point, Acadia has said that it plans to file its NDA for pimavanserin in late 2014, but most analysts expect the filing to come sometime early next year.
In addition to treating PDD, pimavanserin is also being studied for other indications. It’s believed the drug could be effective in treating Alzheimer’s disease psychosis for which there are no effective treatments available, as well as for use as a co-therapy for the treatment of schizophrenia.
With safety and tolerability already well established in earlier studies, trials for additional indications will focus primarily on efficacy.
In addition to pimavanserin, Acadia also has a product candidate in Phase II trials for the treatment of chronic pain caused by conditions such as diabetes, arthritis, migraine, fibromyalgia, irritable bowel syndrome, cancer, shingles, and previous trauma or injury. It has another candidate in Phase I trials geared towards treating glaucoma.
Since Acadia is still a development stage company it continues to burn cash, averaging about $30 million annually. However, after raising $80 million with the sale of 9.5 million shares in December, the company is in a strong financial position, with about $200 million in cash on its balance sheet.
Consequently, Acadia can continue funding its current research program without the need for additional equity issuance, although it will likely need to raise additional funds if it doesn’t partner up to market pimavanserin.
That said, with shares currently trading for less than $20, there is still significant upside opportunity ahead. Pimavanserin is likely to receive quick approval, thanks to its status as an orphan drug. There is also a large addressable market.
At least 6 million people around the world currently suffer from Parkinson’s disease and, if statistics hold true, more than half of them will have developed PDD. The population of the developed world is also continuing to age, enlarging the pool of potential patients.
At the same time, pimavanserin will improve the quality of life for Parkinson’s patients, many of whom are eventually institutionalized because of PDD. By reducing, if not eliminating, many of the psychological effects of the disease, patients will be able to remain in their home settings.
A progressive neurological disorder, Parkinson’s disease is fairly common in older adults. While it can run in families and affect younger people, it most often develops after the age of 50, affecting men and women roughly equally. Nearly 2 percent of those older than age 65 suffer from Parkinson’s.
Symptoms typically begin mildly, with patients initially experiencing a slight tremor, a stiff leg or dragging foot. With time, symptoms include difficulty swallowing or initiating movement, muscle rigidity, worsening tremors and trouble speaking among others.
If the symptoms ended there, the disease would be bad enough. But an estimated 50 percent to 80 percent of patients with Parkinson’s go on to experience Parkinson’s disease dementia (PDD) within 10 years of first being diagnosed with Parkinson’s disease.
PDD results in changes in memory and concentration, difficulty making decisions and interpreting visual information, hallucinations and delusions and, in some cases, violent behavior.
There are no treatments currently available that specifically target PDD, so physicians typically use currently marketed antipsychotic medications or off-label indications to try to minimize symptoms. Unfortunately, many antipsychotic medications block dopamine uptake and worsen the physical symptoms of Parkinson’s.
Acadia Pharmaceuticals (NSDQ: ACAD) has developed a new chemical entity called pimavanserin in trials that could be the answer to those problems.
Last November, the company announced that in a Phase III study, pimavanserin treatment showed strong efficacy in treating PDD and reducing psychotic symptoms without compromising a patient’s motor control.
Tolerability and safety data were also positive, with few side effects compared to a placebo. Pimavanserin also improved nighttime sleep and daytime wakefulness.
The US Food and Drug Administration (FDA) has agreed that the data already collected supports the filing of a new drug application (NDA). Despite that, the company has opted to continue extension trails of two studies to accumulate more long-term safety data on the drug, as well as supportive studies such as those for drug interactions.
At this point, Acadia has said that it plans to file its NDA for pimavanserin in late 2014, but most analysts expect the filing to come sometime early next year.
In addition to treating PDD, pimavanserin is also being studied for other indications. It’s believed the drug could be effective in treating Alzheimer’s disease psychosis for which there are no effective treatments available, as well as for use as a co-therapy for the treatment of schizophrenia.
With safety and tolerability already well established in earlier studies, trials for additional indications will focus primarily on efficacy.
In addition to pimavanserin, Acadia also has a product candidate in Phase II trials for the treatment of chronic pain caused by conditions such as diabetes, arthritis, migraine, fibromyalgia, irritable bowel syndrome, cancer, shingles, and previous trauma or injury. It has another candidate in Phase I trials geared towards treating glaucoma.
Since Acadia is still a development stage company it continues to burn cash, averaging about $30 million annually. However, after raising $80 million with the sale of 9.5 million shares in December, the company is in a strong financial position, with about $200 million in cash on its balance sheet.
Consequently, Acadia can continue funding its current research program without the need for additional equity issuance, although it will likely need to raise additional funds if it doesn’t partner up to market pimavanserin.
That said, with shares currently trading for less than $20, there is still significant upside opportunity ahead. Pimavanserin is likely to receive quick approval, thanks to its status as an orphan drug. There is also a large addressable market.
At least 6 million people around the world currently suffer from Parkinson’s disease and, if statistics hold true, more than half of them will have developed PDD. The population of the developed world is also continuing to age, enlarging the pool of potential patients.
At the same time, pimavanserin will improve the quality of life for Parkinson’s patients, many of whom are eventually institutionalized because of PDD. By reducing, if not eliminating, many of the psychological effects of the disease, patients will be able to remain in their home settings.