Intec Pharma has developed a unique drug delivery platform, the accordion pill (AP) and is enrolling a 420-patient trial of AP-CDLD for Parkinson’s disease (PD), with full enrolment expected in Q318. Many of the adverse effects associated with the treatment of PD with levodopa (the standard of care), such as off-time and troublesome dyskinesia, are directly associated with its pharmacokinetic (PK) profile. Recently released data from two PK studies of AP-CDLD showed their formulation had lower...
Intec Pharma recently released the results from two pharmacokinetic (PK) studies of AP-CDLD (n=18 and n=30). The data showed trends towards lower peak serum concentrations (Cmax) and a longer half-life (T1/2, although there was some inconsistency), which should reduce dyskinesia and off-time, respectively. Additionally, one study measured food effect, which was present but did not delay onset of effects, unlike the approved extended-release carbidopa/levodopa formulation, Rytary.
The year 2017 was marked by steady progress in Intec’s development program of AP-CDLD for the treatment of Parkinson’s disease (PD). The drug is a co-formulation of widely used carbidopa and levodopa using the company’s proprietary accordion pill (AP) technology. The program is in Phase III with more than 300 (of 420) patients enrolled to date with full enrolment expected in H218.
Intec Pharma’s clinical programmes to validate the utility of its unique drug delivery platform, the accordion pill (AP), are ongoing. The company announced with its Q317 report that patient enrolment for the Phase III AP-CDLD (carbidopa and levodopa) in Parkinson’s has been increased to 420 patients (from 328). We now expect full enrolment in Q318. Additionally, Intec is redesigning AP-CBD/THC (cannabidiol and tetrahydrocannabinol) for a second Phase I trial and the indication is not yet sp...
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