Parkinson Disease

Q & A Parkinson Disease with Randall Moreadith, MD, PhD – President and CEO of Serina Therapeutics

The HudsonAlpha Institute for Biotechnology is a nonprofit research institute, but also has more than 30 for-profit biotech companies on its campus. One company in particular is Serina Therapeutics, a pharmaceutical company that has developed a proprietary, patented polymer technology for drug development. Using this technology, the company developed a once-a-week injection, called SER-214, which may not only reduce the amount of needed treatments, but it may also become an alternative to levodopa—a common Parkinson’s drug which causes a well-known side effect associated with the disease.

How common is Parkinson disease in the U.S.?

As many as one million Americans in the US are presently diagnosed with Parkinson disease, and approximately 60,000 new patients are diagnosed every year. It is one of the most common and debilitating neurological diseases in the US and worldwide, with as many as 10 million patients worldwide.

If a family member has Parkinson disease, what is the likelihood that I will also receive a diagnosis?

Most patients who are diagnosed with Parkinson disease have the non-familial form of the disease, which means they do not have a genetic predisposition to developing the disorder. Only about 5 % of Parkinson disease is inherited. That means 95% of the patients who are diagnosed, generally at an age over 50, do not have an identifiable genetic link to developing the disease. There is much work being done to identify genetic links to the disease, and in the future it may be possible to diagnose the disease with a genetic test before one even begins to develop signs or symptoms of the disease.

What types of treatment options are available?

There are many treatment options for patients with Parkinson disease, both pharmacological – meaning drugs – to nonpharmacological such as dance and exercise, and final- ly even surgery. The most commonly prescribed drug for Parkinson disease is levodopa given as an oral formula in combination with another drug that inhibits the break- down of levodopa before it can enter the brain. Once levodopa enters the brain, it is converted to the missing chemical in the brain that leads to the disorder – dopa- mine. Dopamine is a neurotransmitter that is required for normal coordination … if it is deficient, then one begins to develop the common manifestations of the disorder including tremors, bradykinesia and gait disturbance such as imbalance. There are other drugs that act like dopamine in the brain we call those dopamine agonists. Commonly employed dopamine agonists include rotigotine – which is available in a transdermal patch, and ropinirole and pramipexole, which are available as oral drugs. All of these drugs can be used to control the symptoms in Parkinson disease, but like many drugs, they have side effects including nausea, somnolence, pathologic gambling, onset of involuntary motor fluctuations known as dyskinesia, and hypersexuality. Other classes of drugs include those that prevent the normal metabolism of dopamine by inhibiting the enzymes that convert dopamine to its metabolic end products in the brain (MAO-B inhibitors), as well as those that inhibit it’s breakdown in the blood (COMT inhibitors).

   Finally, if the options described above do not provide symptomatic relief, then surgical options are available including an intestinal catheter that delivers levodopa continuously into the small intestive, and an invasive procedure known as deep brain stimulation (DBS). The latter approach involves implantation of electrodes within the brain that provide tiny pulses of electrical stimulation that can provide dramatic improvements in some patients but there can be complications with the surgical procedure. The intestinal catheter and surgery are generally reserved for patients with significantly advanced disease.

What is SER-214?

SER-214 is an injectable candidate drug that can be taken just like you take an insulin shot, except that you would take it once a week. We programmed this pharmacokinet- ic profile using our polymer drug platform, which allows drugs to be delivered as a single injection. The drug at- tached to the polymer is rotigotine, which is a known safe and effective drug that can be delivered as a transdermal patch on a daily basis (Neupro). The advantages of SER- 214 over the patch are significant – you have to shave your body to apply the patch, it often causes significant skin irritation and itching, and it can fall off if you sweat. There are chemical components in the patch that can also cause an acute allergic reaction. SER-214 goes into the blood directly following the injection – no shaving, no skin irritation, no sig- nificant side effects, and it delivers rotigotine continuously over a one-week period. There is no product like this right now, and we are in Phase I development now in Parkinson disease patients.

Have you started clinical trials?

We are in the earliest phase of clinical development now known as Phase I. Our Phase I study is being conducted in Parkinson disease patients, and you can read more about this on our website at www.serinatherapeutics.com. On the website, you can pull down a fact sheet as well as the entire description of the trial on ClinicalTrials.gov site.

How far away are we from a cure?

That is a great question, and it is the mission of organizations like the Michael J Fox Foundation who want to achieve that. We may be years away from curing the disorder, but in the meantime there are effective treatment options that are available to control the symptoms of the disorder while we work diligently to find a cure for this very common and often debilitating disease.