Intec Pharma has enrolled the first patient in the US under its phase III clinical trial for Accordion Pill Carbidopa/Levodopa (AP-CDLD) for treatment of patients with advanced Parkinson’s disease.
Under the multi-centre, randomised, double blind, double-dummy, parallel, active-controlled phase III trial, around 460 participants will be enrolled in two segments, including AP-CDLD or Sinemet IR, an immediate release CDLD, which is a currently available and conventional Levodopa medication for treatment of Parkinson’s disease symptoms.
The trial’s primary efficacy endpoint will be a change from baseline to termination of treatment in the percent of daily off time, which is debilitating periods of decreased motor and non-motor functions during waking hours based on Hauser home diaries.
Henry Ford West Bloomfield Hospital Parkinson’s Disease and Movement Disorders Program director Peter A LeWitt MD said: "A major unmet need for many Parkinson’s disease patients is to improve duration and consistency of symptom relief provided by Levodopa.
"In its Phase II trial, AP-CDLD achieved more uniform drug blood concentrations than current orally-administered Levodopa products, and demonstrated a statistically significant reduction of off-time and decreasing troublesome dyskinesia."
According to reports by Global Data, Parkinson’s disease is considered to be the second most common chronic progressive neurodegenerative disorder in the elderly, affecting 1%-2% of individuals aged below 65 years across the globe.
European Parkinson’s Association reports revealed that over six million people worldwide are suffering from the disease.
New studies have showed that up to 50% of patients demonstrate the beginning of motor fluctuations within two years of starting conventional Levodopa therapy.
During Intec Pharma’s phase II clinical trial of AP-CDLD, participants getting AP-CDLD for three weeks demonstrated a statistical drop in average total daily off time by 44% in one group and 45% in the second group.
In addition, average total daily time of troublesome dyskinesia was not increased in one group and was decreased by 42% in the second group, resulting the average daily total ‘good’ on-time, which is a period with no troublesome dyskinesia, was increased by 2.1 and 2.7 hours in those groups respectively.
Intec Pharma CEO Zeev Weiss said: "We are committed to providing a replacement Levodopa treatment to advanced Parkinson’s disease patients that experience off states for hours during a typical waking day.
"For Intec Pharma, improving the current treatment of this very prevalent and severe neurodegenerative disease is an important mission, and today we achieved a significant milestone related to this mission."