Intec Pharma Ltd. is a tiny company in the space of pot stocks, doing clinical research involving cannabis. But one of their drugs failed a Stage III clinical trial. Intec’s stock got crushed and lost 81 percent of its value.
Intec has three drugs in its pipeline, including cannabis and cannabinoid-derived therapies. It is part of a universe of cannabis stocks whose lives are hinging on clinical trial performance.
Intec’s drug ACCORDANCE did not achieve its primary endpoint in the treatment for Parkinson’s.
What is ACCORDANCE and does this mean the end of Intec as a company in the realm of cannabis stocks?
Intec creates drugs in what it refers to as its “Accordion Pill platform technology,” an oral delivery system that doesn’t alter the actual drug, but its retention and release pathways supposedly improve both safety and effectiveness.
ACCORDANCE is the Carbidopa/Levodopa (AP-CDLD) that failed to hit its primary Phase III trial for symptoms in advanced patients.
Phase III studies use as many as 3,000 patients over a trial period ranging between one and four years. Double-blind randomized trials are used to evaluate the effectiveness and adverse reactions. Less than 24 percent of drug candidates make it past this phase, which is why cannabis stocks for pharmaceuticals rarely survive the market.
Intec had hoped to compete with Merck’s landmark SINEMET drug, which is a mix of carbidopa and levodopa.
The idea for Intec was to improve how Levodopa is absorbed in the small intestine.
As it stands, the drug’s benefits kick in right away but only last about four hours, although it could last as long as 24 hours. It depends on the absorption rate, and food intake has to be limited prior to ingestion or it will slow down the absorption.
Intec’s theory was that by using biodegradable polymeric films and then folding them into an accordion shape, that would release the drug more slowly, allow more consistent absorption, and permit the drug’s effects to last longer.
This was the big kahuna for Intec and would have generated the revenues necessary to keep funding the cannabis portion of its portfolio.
Intec had been advancing its cannabidiol and cannbinol drugs with its Accordion Platform, hoping to increase effect duration, not delay onset as much, and create a standardized dosage.
Both Cannabidiol and 9-Tetrahydrocannabinol (AP-CBD/THC) are in Phase I trials, with the hope that the Accordion Platform will improve pain management delivery.
All cannabis stocks hinge on the outcome of clinical-stage trials at every firm because psychologically the stock market and investors believe that failure of cannabis-derived therapies at one may mean failures across the board.
Last modified: September 23, 2020 12:51 PM