Results from an open-label two-way crossover Phase 2 clinical trialevaluating Intec Pharma’s (NASDAQ:NTEC) Accordion Pill – Carbidopa/Levodopa (AP-CD/LD) in Parkinson’s disease (PD) patients showed a treatment effect. The data were just published in the journal Parkinson’s and Related Disorders.
Pharmacokinetic (PK) results showed that either AP-CD/LD dose produced stable plasma concentrations in both fluctuating and non-fluctuating PD patients. The PK profile was better than other orally administered LD products and on par with intestinal CD/LD infusion.
AP-CD/LD 50/375 dosed twice/day or 50/500 dosed twice/day reduced mean daily OFF time by 44% and 45%, respectively, compared to immediate-release CD/LD. Total ON time and good ON time both significantly increased in both cohorts.
No new safety signals were observed.
A Phase 3 trial is in process.
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