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.
Go deeper with GlobalData
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.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataEuropean 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."
