The patent (HK1158545) is titled “Carbidopa/Levodopa Gastroretentive Drug Delivery” and is scheduled to remain active until April 2029. The patent belongs to Intec’s IN-7 patent family that already includes patents in the U.S., European Union, China, Japan, South Africa, and South Korea, among others.
Intec Pharma’s Accordion Pill is an oral drug delivery system designed to improve the effectiveness and safety of existing drugs and drugs in development by utilizing an efficient gastric retention and specific release mechanism.
Levodopa (LD) is one of the most widely used therapies for Parkinson’s disease. However, LD treatment is associated with motor complications, “off” periods (when the drug doesn’t work and symptoms return), and LD-induced dyskinesia (involuntary muscle movements). Parkinson’s disease patients often report “off” periods between levodopa doses due to its short-term effects.
The AP-CD/LD was created to overcome these effects by formulating a gastric-retentive dosage containing carbidopa and levodopa in both immediate and controlled-release methods.
A Phase 2 randomized, multiple-dose, dose-ranging crossover study was conducted in 60 patients with Parkinson’s disease to evaluate the clinical efficacy and safety of AP-CD/LD. The part of the study assessing the effects and mechanism of action of AP-CD/LD consisted of a series of crossover comparisons between the therapy candidate and each patient’s current conventional treatment with LD + DDCI (levodopa plus a dopamine decarboxylase inhibitor) — like carbidopa.
Results showed that total off time was decreased by 44 percent and 45 percent in two patient groups medicated with two different doses of the AP-CD/LD, and the improvements were achieved with significantly fewer LD doses per day.
As reported by Intec Pharma, these findings suggest that AP-CD/LD is capable of providing continuous, stable levodopa plasma levels throughout the day. The drug delivery candidate was also found to be well tolerated with no serious adverse events.
“This Hong Kong patent secures key elements of our Accordion Pill technology platform and our leading product, the Accordion Pill Carbidopa/Levodopa (AP-CD/LD), in significant markets,” Jeffrey A. Meckler, Intec Pharma’s CEO, said in a press release.
“The AP-CD/LD is currently in a global Phase 3 clinical trial in advanced Parkinson’s disease and the expanded patent protection will enhance any global commercial efforts for AP-CD/LD,” he added.
The company’s pipeline includes the AP-CD/LD delivery candidate and the Accordion Pill with the two primary cannabinoids contained in cannabis sativa, cannabidiol (CBD), and tetrahydrocannabinol (THC), or AP-CBD/THC, being developed for several indications including fibromyalgia and low back neuropathic pain.