Intec posts early data on controlled-release cannabis pill

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Israel's Intec will provide an update on its development plans By the end of the year (Courtesy of Zachi Evenor [CC BY 3.0])

Intec Pharma has posted data from a phase 1 trial of its cannabinoid candidate. The early look at the pharmacokinetics achieved by delivering cannabidiol (CBD) and tetrahydrocannabinol (THC) via Intec’s Accordion Pill encouraged the biotech to talk up further development.

Investigators at a single site enrolled 21 healthy volunteers in the trial and randomized them to receive one of two Intec formulations or GW Pharmaceuticals’ Sativex spray. Intec hoped to show its drug delivery technology extends the absorption phase of CBD and THC and, in doing so, avoids peaks and troughs. The Jerusalem, Israel-based biotech thinks this will result in more consistent dosing levels that improve efficacy while minimizing the risk of psychotropic effects. 

Intec has presented a snapshot of data from the trial to support its case. The study linked Intec’s AP-CBD/THC to median exposure times two to three times longer than those achieved by Sativex, which are already far longer than is possible when smoking cannabis or inhaling vaporized extracts. CBD exposure increased by 290% to 330%. THC exposure increased by 25% to 50%.

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The trial also associated AP-CBD/THC with a 25% or more drop in THC metabolites. Intec sees this as a key data point for its candidate.

"We are particularly pleased to see the reduction in THC metabolite, which tells us that the AP-CBD/THC avoided some of the hepatic first-pass metabolism of THC,” Intec COO Nadav Navon, Ph.D. said in a statement.

First-pass metabolism results in the liver breaking down drugs before they enter circulation. Some of the THC delivered in Sativex undergoes first-pass metabolism to create the psychoactive metabolite 11-OH-THC. The level of first-pass metabolism in patients taking Sativex is dictated by the proportion ingested and absorbed through stomach and esophagus.

GW’s decision to deliver CBD and THC via an oromucosal spray enabled it to ensure at least some of the active ingredients enter circulation before passing through the liver. Intec is delivering CBD and THC through the digestive system but nonetheless reported a dip in THC metabolites. 

The Israeli biotech now plans to go over the data with a view to making a decision about further clinical development by the end of the year.