Intec Pharma Announces Results From Pharmacokinetic Study of AP-CD/LD 50/500 mg Dosed Three Times Daily Were Presented at the XXIV World Congress on Parkinson's Disease and Related Disorders
The presentation highlighted data collected during a cross-over PK study comparing AP-CD/LD 50/500 mg TID and standard immediate release (IR) CD/LD 37.5/150 mg 5x daily in patients with PD. PK samples were collected pre-dose and at 30-minute intervals post-dose over 16 hours and again at 24 hours post-dose.
The primary endpoint of the study was the variability in plasma LD concentration in steady state (between four and 16 hours) as assessed by the LD fluctuation index [(Cmax-Cmin)/Cavg)]. The key secondary endpoint was the coefficient of variation (standard deviation of plasma LD concentrations divided by the average concentration). In addition, multiple sensitivity analyses were performed.
The results showed that AP-CD/LD 50/500 mg TID met the study's primary endpoint of reducing plasma levodopa variability compared to standard IR-CD/LD when dosed five times per day (p=0.0048). Less variability was also observed for the coefficient of variation of plasma levodopa levels (key secondary endpoint; p=0.047). These results were supported by the findings of significant outcomes on each of the prespecified sensitivity analyses. AP-CD/LD was well tolerated with no serious adverse events.
The study authors noted that motor complications are associated with variability in plasma levodopa concentration seen with IR levodopa, and concluded that the results of the present study "suggest that treatment with AP-CD/LD may reduce motor complications in patients with advanced PD as compared to standard IR-CD/LD treatment."
"We are delighted to have these positive PK results presented by Dr. Olanow, a world-leading Parkinson's disease expert, at this prestigious medical meeting. These PK results are important as they confirm our expectations that AP-CD/LD 50/500 TID reduces levodopa variability in PD patients, which we expect will translate to a reduction in motor fluctuations in these patients," noted Jeffrey A. Meckler, Vice Chairman and Chief Executive Officer of
Intec Pharma is a clinical-stage biopharmaceutical company focused on developing drugs based on its proprietary Accordion Pill platform technology. The Company's Accordion Pill is an oral drug delivery system that is designed to improve the efficacy and safety of existing drugs and drugs in development by utilizing an efficient gastric retention and specific release mechanism. The Company's product pipeline includes two product candidates in clinical trial stages: Accordion Pill Carbidopa/Levodopa, or AP-CD/LD, which is in late-stage Phase 3 development for the treatment of Parkinson's disease symptoms in advanced Parkinson's disease patients, and AP-cannabinoids, an Accordion Pill to deliver either or both of the primary cannabinoids contained in Cannabis sativa, cannabidiol (CBD) and tetrahydrocannabinol (THC) for various pain indications. In addition, the Company has a feasibility agreement for the development of a custom-designed Accordion Pill for a proprietary compound with
For more information, visit www.intecpharma.com.
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