Intec Pharma Reports Clinical Results From Phase I Trial of Accordion Pill For Cannabinoid Therapies

ISRAEL: Intec Pharma, a clinical stage biopharmaceutical company focused on developing drugs based on its proprietary Accordion Pill platform technology, announced the results from a Phase I clinical trial of AP-CBD/THC, its Accordion Pill platform with cannabidiol (CBD) and tetrahydrocannabinol (THC), the two primary cannabinoids contained in Cannabis sativa.

“We’re excited about these encouraging results from our Phase 1 study of AP-CBD/THC as it shows the Accordion Pill platform is well suited to safely deliver CBD and THC with significant improvements in exposure compared with Sativex,” said Nadav Navon, Ph.D., Chief Operating Officer of Intec Pharma. “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.”

The Phase I trial was a single-center, single-dose, randomized, three-way crossover study to compare the pharmacokinetics, safety and tolerability of two formulations of AP-CBD/THC with Sativex in 21 normal healthy volunteers. Sativex is a commercially available oral buccal spray containing CBD and THC[1].

The study results showed that AP-CBD/THC had significant improvements in exposure of CBD (290% – 330%) and THC (25% – 50%) compared with Sativex. The median time of peak concentration was 2-3 times longer than Sativex and absorption was significantly higher. Importantly, the formation of THC metabolites were meaningfully reduced (>25%) and AP-CBD/THC was found to be safe and well tolerated with no serious adverse events reported.

“This study further affirms the value of our Accordion Pill platform as a safe and effective drug delivery platform,” said Jeffrey A. Meckler, Chief Executive Officer of Intec Pharma. “We plan to review these data in the coming weeks to determine the next steps in developing our AP-CBD/THC program and plan to announce the next steps in the clinical development of this exciting program by year end.”

The Cannabis sativa plant is used for the treatment of chronic pain and a variety of other indications. Previous clinical studies conducted using the whole plant or specific extracts generated evidence of the cannabis analgesic activity. Furthermore, extracts containing known amounts of the active plant driven compounds (mainly THC and CBD) or diverse synthetic THC derivatives are thought to be promising treatments for painful conditions that do not respond properly to currently available treatments, such as chronic, neuropathic and inflammatory pain[2],[3].

AP-CBD/THC holds the potential to address several major drawbacks of current methods of use and treatment with cannabis and cannabinoids, such as short duration of effect, delayed onset, variability of exposure, variability of the administered dose and adverse events that correlate with peak levels. AP-CBD/THC is designed to extend the absorption phase of CBD and THC, resulting in more consistent levels for an improved therapeutic effect.

The cannabis market has significant commercial potential and is projected to represent approximately 10% of the specialty pharmaceutical market over the next five years, or a market of at least $20 billion[4]. According to Global Data, in 2016 the global low back pain drug market was $6.2 billion and the global Fibromyalgia drug market was $1.8 billion.

Marijuana’s Promise Of Profit Remains Elusive (For Now)

NEW YORK: Excitement surrounding medical marijuana led to a significant run-up in GW Pharmaceuticals‘ share price earlier this year, but based on the company’s recently announced quarterly and fiscal full-year earnings results, the promise of marijuana profit remains far off in the distance.

Planning for the future

That’s because GW Pharma has only one marketed marijuana derived therapy, Sativex, on the market, and Sativex, which is used to treat multiple sclerosis spasticity, has yet to win the FDA go-ahead for use in United States. As a result, sales of Sativex, which come primarily from European markets, total just $2 million in the quarter ending June and were small enough for the full fiscal year ending September that the company didn’t bother breaking them out in its quarterly earnings press release.

Instead, the company focused the bulk of its earnings report on the promising opportunity for its marijuana-based medicine across various indications and a slate of trials spanning cancer pain, epilepsy, schizophrenia, and even diabetes.

Those trials are all ongoing, so investors will need to rely on past trial data to make judgments on whether or not the market demand for GW Pharma’s medicine will justify the company’s $1.27 billion market cap.

FDA Approves Clinical Trials For Cannabis-based Epilepsy Drug

DISTRICT OF COLUMBIA: The U.S.  Food and Drug Administration has approved clinical trials of a cannabis-based drug and its effects on epilepsy.  The treatment, Epidiolex, is 98 percent purified cannabidiol ( CBD ) made by GW Pharmaceuticals based out of the U.K.

There are around 60 known chemicals contained in cannabis called cannabinoids.  Tetrahydrocannabinol, also known as THC, is the main component responsible for the drug’s psychoactive nature.  CBD, however, is the second most abundant cannabinoid in the cannabis and provides medicinal benefits without the “high.” [Read more…]