JERUSALEM, Oct. 22, 2018 /PRNewswire/ — Intec Pharma Ltd. (NASDAQ: NTEC) (“Intec” or “the Company”) today announces the completion of patient enrollment in the Company’s pivotal Phase 3 clinical trial (the ACCORDANCE trial) evaluating the safety and efficacy of Accordion Pill™-Carbidopa/Levodopa (AP-CD/LD) compared with immediate release CD/LD (IR-CD/LD; Sinemet®) as a treatment for the symptoms of advanced Parkinson’s disease (PD). The study enrolled 462 patients in the Sinemet titration period to provide approximately 300 patients to be randomized into the double-blinded portion of the study. The study is being conducted at approximately 90 clinical sites throughout the U.S., Europe and Israel.
“We are delighted to achieve this important milestone as it leads us one step closer to potentially bringing a new and much-needed baseline levodopa treatment to advanced PD patients,” stated R. Michael Gendreau, M.D., Ph.D., Chief Medical Officer of Intec Pharma. “The complications associated with advanced PD have a substantial impact on healthcare costs and quality-of-life. By providing more uniform levodopa plasma concentrations than those provided by currently available orally-administered levodopa products, we expect to improve the duration and consistency of symptom relief provided by levodopa with a simpler dosing regimen. We believe the simplified dosing regimen in a baseline levodopa therapy will result in improved motor fluctuation control, reduced symptomology and enhanced compliance.”
“We continue to be pleased with the Phase 3 development program for AP-CD/LD as an improved baseline therapy for advanced PD patients. We remain encouraged that more than 90% of eligible patients are electing to enroll in the open label extension (OLE) study as these data will provide the long-term safety required for our regulatory submission. In addition, we initiated a pharmacokinetic (PK) study of three times per day (TID) dosing with AP-CD/LD 50/500 mg and look forward to obtaining these data, as this was a common dosing regimen in the ACCORDANCE study. We believe understanding this PK profile in advanced PD patients will be important for commercial launch. Plans with our commercial manufacturing partner, LTS Lohmann Therapie-Systeme AG, are advancing and we expect to provide timelines for the validation, stability and bridging studies for our commercial manufacturing process around the end of the year,” commented Jeffrey A. Meckler, Vice Chairman and Chief Executive Officer of Intec Pharma.
About the Phase 3 ACCORDANCE Clinical Trial
The Phase 3 ACCORDANCE clinical trial of AP-CD/LD is a multi-center, global, randomized, double-blind, double-dummy, active-controlled, parallel-group study in adult subjects with advanced PD. Preliminary analysis of the baseline data for the enrolled population shows:
- Average age at study entry was 63 and 65% of enrolled patients were male;
- Entering patients had a diagnosis of PD for 8.8 years on average;
- More than 40% of entering patients required in excess of 800 mg daily of a levodopa (LD) preparation;
- Average daily OFF time for patients upon entering the study was approximately 6.1 hours; and
- Approximately 32% of patients were enrolled in the U.S.
Prior to the 13-week randomized portion of the study, the ACCORDANCE study had two open label periods of 6 weeks each during which all patients in these open label periods were first stabilized and optimized on the active comparator, Sinemet, and then on AP-CD/LD.
The primary efficacy endpoint of the study is the change from baseline to endpoint in the percent of daily OFF time during waking hours based on Hauser home diaries. The study is 90% powered to be statistically significant for a one-hour difference in OFF time between Sinemet and AP-CD/LD.
Secondary endpoints currently include change from baseline to endpoint in “ON time” without troublesome dyskinesia during waking hours, CGI-I at endpoint as recorded by physician and patient and change from baseline through endpoint in the Unified Parkinson’s Disease Rating Scale (UPDRS) Score domains.
All patients completing the 13-week randomized period are eligible to continue in an OLE study in which they will receive treatment with AP-CD/LD for an additional 12 months. To date, more than 90% of eligible patients have elected to enter the OLE study.