Dopamine is a chemical messenger (aka, a neurotransmitter) in the brain. That means it carries signals from one cell in the brain to the next until it reaches a receptor, which relays the signal to its intended target.
The dopamine producing neurons in the substantia nigra portion of the brain stem are part of a bundle of fibers that are important in the facilitation of body movement. If these neurons die, a person will have severe movement-related issues, which are expressed as symptoms of the neurodegenerative disorder known as Parkinson’s disease. Everyone recognizes the trembling and impaired motor functions of someone with Parkinson’s.
Today there is no known cure for Parkinson’s disease. The treatment is simply taking doses of a drug called levodopa to increase the amount of dopamine in the brain and make up for the lowered levels.
Although levodopa has been administered orally for decades, this method has a number of limitations, leaving the treatment to be inadequate. Most significantly, the oral dosage remains in the blood for too short a period and it has low absorption. Because of this, doctors have difficulty prescribing the correct dosage. Too low a dose won’t do the trick, but too high a dose can result in involuntary movements (dyskinesia) that interfere with their daily lives.
Two Israeli companies are in the process of developing solutions to these limitations.
NeuroDerm is a clinical stage pharmaceutical company that was founded in 2003 and for the first 8 years of growth had under 10 people on their team. In November 2014 they went public, raising $45 million, and now trade on Nasdaq and have over 70 employees.
According to their website, NeuroDerm has developed patented liquid formulations that, for the first time, enables 24-hour, day and night, continuous subcutaneous administration of Levodopa/Carbidopa (LD/CD). By delivering directly into the bloodstream via the skin they are able to maintain steady therapeutic levodopa levels and offer patients an improved quality of life. NeuroDerm’s LD/CD portfolio includes three product candidates, for moderate, moderate to severe and very severe PD patients, all aimed at overcoming the most significant limitations of current LD/CD therapy.
Due to their recent successful open trial of the drug they are expanding their Phase III clinical trial in Europe and are conducting bioequivalence trials in the US.
Intec Pharma‘s approach is yet another application of their proprietary Accordion PillTM platform. The late-stage biopharmaceutical company was founded earlier than NeuroDerm (in 2000) but began trading on Nasdaq later than them (August 2015).
The Accordion PillTM is a gastro-retentive delivery system that is specifically designed for drugs with either a narrow absorption window or poorly soluble. It is a multi-layer, planar structure, folded to an accordion shape into a standard size, regular capsule. Upon reaching the stomach, the capsule dissolves, the Accordion PillTM unfolds and is retained in the stomach for up to 12 hours. While in the stomach, the Accordion PillTM releases the drug in a controlled manner towards the upper part of the gastrointestinal tract.
The company’s product pipeline currently includes three product candidates in clinical trial stages that are being developed for the treatment of Parkinson’s disease symptoms (currently in Phase III), for the treatment of insomnia, including sleep induction and sleep maintenance, and for the prevention and treatment of gastroduodenal and small bowel ulcers induced by Nonsteroidal Anti-Inflammatory Drugs. In addition, an Accordion PillTM for cannabinoid therapies (AP-CBD/THC) will enter Phase I clinical trials in the first quarter of 2017.
I actually have a slight personal connection with both of these companies. When I was working at Luzzatto & Luzzatto I recall receiving a tour of Intec Pharma’s offices in Jerusalem and learning about their product. I performed a patent search for them and was impressed with the technology, which left me with a positive impression about the company. On the other hand, not long ago, a recruiting agency contacted me on behalf of NeuroDerm regarding a Patent Director position they were looking to fill. Out of curiosity, I travelled to Rehovot to be interviewed. They didn’t offer me the position!
It seems like NeuroDerm and Intec Pharma are at a race toward the finish line to see whose product will reach the market first. I wish both of these Israeli companies the best (but I’m secretly rooting for Intec Pharma.)