Intec Pharma announces AP-CD/LD didn't achieve statistical superiority in study
Intec Pharma announces top-line data from the company's pivotal Phase 3 ACCORDANCE trial evaluating the safety and efficacy of the Accordion Pill-Carbidopa/Levodopa, or AP-CD/LD, compared with immediate release IR-CD/LD, or Sinemet, as a treatment for the symptoms of advanced Parkinson's disease. The company announced that the ACCORDANCE study did not achieve statistical superiority to Sinemet on the primary endpoint of reduction in daily OFF time. The primary efficacy endpoint of the study was the change from baseline to endpoint in the percent of daily OFF time during waking hours based on Hauser home diaries. The study was 90% powered to detect a one-hour difference in OFF time between Sinemet and AP-CD/LD. Under the protocol and conditions of the ACCORDANCE study, AP CD/LD did not demonstrate statistical superiority to Sinemet on daily OFF time. Secondary endpoints include change from baseline to endpoint in ON time without troublesome dyskinesia during waking hours, CGI-I at endpoint and change from baseline through endpoint in the Unified Parkinson's Disease Rating Scale Score Parts 2 and 3. AP-CD/LD also did not achieve statistical superiority on these endpoints. Treatment-emergent adverse effects observed with AP-CD/LD were generally consistent with the known safety profile of CD/LD formulations. No new safety issues were observed throughout the double-blinded study, during the gastroscopy safety sub-study or the 12-month open-label extension study. "We are disappointed that the ACCORDANCE study didn't meet its target endpoints with statistical significance. While the data suggests that the AP CD/LD did achieve an acceptable safety profile and did treat Parkinson's disease symptoms, it did not achieve a statistically significant superiority to standard immediate release levodopa therapy. We are pleased with the good safety profile of the AP-CD/LD, as it demonstrates for the first time the long-term safety of the Accordion Pill, which is important for future potential applications and partnerships," stated Jeffrey Meckler, Vice Chairman and CEO of Intec Pharma. R. Michael Gendreau, Chief Medical Officer of Intec Pharma, said, "Upon our on-going preliminary review of the data, we have noted that certain subsets of patients performed particularly well. In those patients, we see a meaningful reduction in OFF time. We will continue to analyze the full data set and expect that such findings will help inform our strategy for AP-CD/LD moving forward."