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

Intec Pharma Ltd. (NASDAQ: NTEC) (“Intec” or “the Company”) today announced that results from a pharmacokinetics (PK) study of the Accordion Pill™-Carbidopa/Levodopa (AP-CD/LD) 50/500 mg dosed three times per day (TID) were highlighted yesterday in a  poster presentation at the XXIV World Congress on Parkinson’s Disease and Related Disorders taking place June 16-19, 2019in Montreal, Canada.

C. Warren Olanow, M.D., Professor and Chair Emeritus, Department of Neurology at Mount Sinai School of Medicine, New York, was the Senior Author of the Poster which is titled, “Pharmacokinetics of multiple doses of Accordion Pill Carbidopa/Levodopa in patients with Parkinson’s disease.”  The poster can be accessed here.

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. “We are eagerly awaiting the top-line results from our Phase 3 ACCORDANCE trial in the July/August time frame and these positive PK data support our belief that AP-CD/LD treatment could provide Parkinson’s disease patients with a better baseline LD therapy to reduce motor complications.” – BioSpace