Intec Pharma Ltd. (NASDAQ: NTEC) (TASE: INTP), a clinical-stage biopharmaceutical company, today announced the enrollment in the U.S. of the first patient in its pivotal Phase III clinical trial for its lead product candidate, the Accordion Pill Carbidopa/Levodopa, or AP-CDLD, for the treatment of Parkinson's disease symptoms in advanced Parkinson's disease patients.
"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." said Peter A. LeWitt MD, Professor of Neurology at the Wayne State University School of Medicine, Director, Parkinson's Disease and Movement Disorders Program at Henry Ford West Bloomfield Hospital and a member of Intec Pharma's Scientific Advisory Team.
The multi-center, randomized, double blind, double-dummy, parallel, active-controlled Phase III trial is expected to enroll approximately 460 participants across two arms: AP-CDLD or Sinemet® IR, an immediate release CDLD, which is a conventional Levodopa medication for the treatment of Parkinson's disease symptoms that is currently on the market. The primary efficacy endpoint will be a change from baseline to termination of treatment in the percent of daily off time during waking hours based on Hauser home diaries. "Off time" refers to debilitating periods of decreased motor and non-motor functions.
Parkinson's disease is the second most common chronic progressive neurodegenerative disorder in the elderly, affecting 1%-2% of individuals ages ≥65 years worldwide[1]. More than 6 million people worldwide have Parkinson's disease[2].
"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." said Peter A. LeWitt MD, Professor of Neurology at the Wayne State University School of Medicine, Director, Parkinson's Disease and Movement Disorders Program at Henry Ford West Bloomfield Hospital and a member of Intec Pharma's Scientific Advisory Team.
The multi-center, randomized, double blind, double-dummy, parallel, active-controlled Phase III trial is expected to enroll approximately 460 participants across two arms: AP-CDLD or Sinemet® IR, an immediate release CDLD, which is a conventional Levodopa medication for the treatment of Parkinson's disease symptoms that is currently on the market. The primary efficacy endpoint will be a change from baseline to termination of treatment in the percent of daily off time during waking hours based on Hauser home diaries. "Off time" refers to debilitating periods of decreased motor and non-motor functions.
Parkinson's disease is the second most common chronic progressive neurodegenerative disorder in the elderly, affecting 1%-2% of individuals ages ≥65 years worldwide[1]. More than 6 million people worldwide have Parkinson's disease[2].
In 2012, the market for drugs for Parkinson's disease was approximately $3.6 billion a year in the seven major markets (the United States, Japan, France, Germany, Italy, Spain and the United Kingdom) plus Brazil[1]. Of all these drugs, Levodopa is generally considered to be the most effective and most prescribed therapy for the treatment of Parkinson's disease symptoms.
However, recent studies have reported that up to 50% of patients show the onset of motor fluctuations within two years of starting conventional Levodopa therapy. For many patients with advanced Parkinson's disease, the repeated emergence of off states can occupy up to one-third or more of a typical waking day. The off states between Levodopa doses occur in parallel to the drug's pharmacokinetics profile. Therefore, improving the consistency in Levodopa's plasma levels becomes the major factor for improving symptom control in advanced Parkinson's patients.
In the company's Phase II clinical trial of AP-CDLD, participants receiving AP-CDLD for three weeks showed a statistically significant reduction in average total daily off time by 44% in one group and 45% in the second group (p<0.0001). In addition, average total daily time of troublesome dyskinesia was not increased in one group and was decreased by 42% in the second group (p=0.002). As a result, the average daily total "good" on-time (i.e; on-time with no troublesome dyskinesia) was increased by 2.1 and 2.7 hours in those groups, respectively (p<0.0001).
However, recent studies have reported that up to 50% of patients show the onset of motor fluctuations within two years of starting conventional Levodopa therapy. For many patients with advanced Parkinson's disease, the repeated emergence of off states can occupy up to one-third or more of a typical waking day. The off states between Levodopa doses occur in parallel to the drug's pharmacokinetics profile. Therefore, improving the consistency in Levodopa's plasma levels becomes the major factor for improving symptom control in advanced Parkinson's patients.
In the company's Phase II clinical trial of AP-CDLD, participants receiving AP-CDLD for three weeks showed a statistically significant reduction in average total daily off time by 44% in one group and 45% in the second group (p<0.0001). In addition, average total daily time of troublesome dyskinesia was not increased in one group and was decreased by 42% in the second group (p=0.002). As a result, the average daily total "good" on-time (i.e; on-time with no troublesome dyskinesia) was increased by 2.1 and 2.7 hours in those groups, respectively (p<0.0001).
"The Phase III clinical trial should be able to demonstrate whether the Accordion Pill can confirm the Phase II results and show meaningful improvement in symptom control for patients experiencing irregular benefits from Levodopa." Said Dr. LeWitt.
"Enrolling a first patient in our single pivotal Phase III clinical trial is an exciting milestone for Intec Pharma. 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" said Zeev Weiss, CEO of Intec Pharma.
"Enrolling a first patient in our single pivotal Phase III clinical trial is an exciting milestone for Intec Pharma. 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" said Zeev Weiss, CEO of Intec Pharma.
http://www.prnewswire.com/news-releases/intec-pharma-enrolls-first-patient-in-pivotal-phase-iii-clinical-trial-of-ap-cdld-for-advanced-parkinsons-disease-patients-574459481.html?
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