Intec Pharma has been granted a Chinese patent covering the company’s Accordion Pill, an experimental technology platform to allow for the prolonged absorption of drugs with a small absorption window, such as the combination of carbidopa and levodopa for the treatment of Parkinson’s disease (PD).
The patent granted by the State Intellectual Property Office of the People’s Republic of China (SIPO) is effective until April 2029, and belongs to Intec’s IN-7 patent family, which includes patents granted in the United States, Europe, and Israel.
A Phase 3 clinical trial (NCT02605434) is currently testing the pill’s effectiveness — in combination with two primary treatments for Parkinson’s, carbidopa and levodopa (known as Accordion Pill Carbidopa/Levodopa) — in reducing “off time” motor fluctuations in people with advanced disease. The global and randomized trial, comparing that pill’s effectiveness against Sinemet (carbidopa-levodopa immediate release) or placebo, is currently recruiting patients. More information is available on its clinical trials.gov webpage.
Levodopa (L-dopa), a drug that belongs to a class of medications called central nervous system agents, and works by being converted to dopamine in the brain. It is almost always prescribed in combination with carbidopa, which belongs to a class of drugs known as decarboxylase inhibitors, and works by preventing levodopa from breaking down before it reaches the brain. This allows the use of lower doses of levodopa, resulting in fewer unpleasant side effects like nausea and vomiting, according to the National Institutes of Health.
The Accordion Pill is designed to aid in the pharmacokinetics of drugs with either a narrow absorption window (poor colonic absorption), or drugs that are poorly soluble (belonging to Biopharmaceutics Classification System (BCS) class II or IV). The platform provides for a prolonged absorption phase for drugs, resulting in improved pharmacokinetic parameters and, often, better drug efficacy, safety and dose regimen.
“We continue to globally expand and strengthen our patent portfolio for our IN-7 patent family in order to build a fortress intellectual property position that will protect our Accordion Pill technology platform,” Zeev Weiss, chief executive officer of Intec Pharma, said in a recent press release. “This Chinese patent secures key elements of our Accordion Pill technology platform and our leading product, the Accordion Pill Carbidopa/Levodopa, in significant markets.”
According to the company, between 30 percent and 45 percent of medications on the market today are poorly soluble, a problem the Accordion Pill addresses by retaining the dosage form in the stomach and then releasing the drug gradually into the upper part of the gastrointestinal tract.