Intec Pharma is pleased to report the intermediate results of the phase IIb clinical trial for the first group of advanced Parkinson's disease patients, with the Accordion-Pill-Levodopa product.
An analysis of the results showed that the administration of the Levodopa drug with the Accordion-Pill significantly improved its efficacy.
This improvement is of statistical significance (as detailed below). In addition, the administration of the drug with the Accordion-Pill, allowed a significant reduction in the number of doses per day in comparison to the currently marketed Levodopa product.
12 advanced Parkinson's disease patients participated in this study, conducted in three centers; Sourasky Tel-Aviv Medical Center (Ichilov), Rabin Medical Center (Beilinson) and Sheba Medical Center (Tel Hashomer). The patients were treated with the Accordion-Pill-Levodopa product for a period of one week, and then crossed over for a second week in which they were treated with their currently marketed Levodopa treatment regimen (in a randomized manner).
The efficacy of the Accordion-Pill-Levodopa product was tested during 16 hours (waking hours) a day, in comparison to the current treatment regimen. The safety of the Accordion-Pill-Levodopa was also tested during this study.
The following is an analysis of the main intermediate results as received by the Company prior to this publication: In 10 patients who completed the study in accordance with the study protocol, a statistically significant decrease in 'OFF time' (when the patient shows significantly decreased motor functions) and statistically significant reduction in the number of doses per day were achieved. In 80% of these patients an average reduction of about 35% in the OFF time (2.96 hours compared to 4.48 hours with their current treatment) was achieved, which is statistically significant. The number of daily doses in this patient group was reduced by half (from 6.0 times per day to 3.2 times per day).
With respect to product safety, the Accordion-Pill-Levodopa product once again proved its good safety profile and no significant adverse effects were reported during the study. The success of this study follows a successful phase IIa study conducted in early stage Parkinson's patients. To the Company's knowledge, the intermediate results achieved in this study, with respect to the reduction in the number of daily doses together with the reduction in the duration of motor dysfunction, are unprecedented in comparison to currently marketed orally administered Levodopa products.
The Company estimates that these intermediate results improve the prospects for success in the additional clinical stages that are needed for the completion of this clinical study which are expected to continue for several months. The Company estimates that if the Accordion-Pill-Levodopa is approved for marketing, it may reach annual sales of $800 Million.
Parkinson's disease Parkinson's disease is a degenerative disease of the central nervous system, characterized by motor disorders, such as slowed and reduced mobility, involuntary tremors, muscle stiffness, balance disturbances and instability. At the late stages of the disease the patient experiences an overall functional limitation. In 2007 there were approximately 1.45 Million Parkinson's disease patients in the USA, Japan and the 5 major European countries[1].
The drug market for Parkinson's disease in these markets was estimated at approximately $2.1 Billion in 2008 and is estimated to reach $2.9 Billion by 2015[2]. The disease is caused by an ongoing loss of the brain's ability to produce Dopamine, which is required for normal brain functionality. The most efficient drug for treatment of the Parkinson's symptoms is Levodopa. When the Levodopa reaches the brain, it transforms into Dopamine, whose deficiency causes the disease. Nonetheless, the use of Levodopa is associated with severe motor disturbances and a need for frequent doses throughout the day, due to acute fluctuations of the drug levels in the blood.
The need to develop a formulation which will significantly reduce motor disturbances associated with Levadopa treatment and daily dosing remained unanswered for decades. Accordion-Pill-Levodopa Accordion-Pill-Levodopa is a designated oral delivery platform developed by Intec Pharma which contains Carbidopa and Levodopa in different doses, for the treatment of the different stages of the disease.
The Accordion-Pill-Levodopa is designed to stabilize Levodopa levels in the blood and thereby bring about, for the first time, a dramatic reduction in motor disturbances and reduce the frequency of daily dosing, using oral treatment. The Company's estimations for future development, expected clinical trials and sales forecasts, with respect to the Company's products, is forward looking information that is based on information in the Company's hands today with respect to drugs development potential and the indications it has received from relevant health care authorities.
These estimates may not be realized, in whole or in part, and/or may be realized differently than estimated, as a result of different factors, including failure to reach the objectives of the studies and/or schedules and/or necessary funding for further drug development and failure to obtain regulatory approvals required for further development, failure to reach collaboration with international companies and other factors which are not within the Company's control and the materialization of any of the risk factors that relate to the Company's activities.
Sincerely,
Intec Pharma
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