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Raphael Mechoulam, an Israeli organic chemist and professor of medicinal chemistry at the Hebrew University of Jerusalem, remembers the disappointment after his revolutionary discoveries about the structure of CBD and THC cannabis compounds in 1963 and 1964, followed by clinical trials with CBD published in 1980..
"It did not happen much," said Mechoulam, pointing out that it would take more than 30 years before his clinical work on the use of CBD, or cannabidiol, to treat the condition. Epilepsy are not widely accepted. Greenwich Biosciences, owned by GW Pharmaceuticals, was able to develop the first cannabis derivative drug based on Mechoulam's research. The drug, Epidiolex, treats seizures associated with two rare forms of epilepsy and was only approved by the FDA last year.
But even if his work lays the foundations of the modern cannabis industry and allows him to understand the interaction of cannabis with the human body, research on the white whale escapes research: cannabis acids, compounds that are produced in the plant while alive and may be more potent than their more well-known derivatives, such as CBD and THC.
This changed on Monday, when Mechoulam and a group of researchers announced at a medical cannabis conference in Pasadena, California, that they had developed a process to create synthetic and stable acids. , present in the plant, and that these synthetic acids, including: acidic versions of CBD and THC, are now available to licensed companies for drug development
This discovery paves the way for pharmaceutical companies to potentially develop new acid-based drugs for a variety of health conditions such as psoriasis, arthritis, anxiety, and inflammatory bowel disease.
The research is the product of a start-up company called EPM, in partnership with Mechoulam, six Israeli universities, the UK and Canada, the world's largest topical cream company and a publicly traded laboratory company.
"I think it's a big problem," said Mechoulam, who is the head of research at EPM, comparing it to his discoveries on CBD and THC.
In a study published in 2018 by the British Journal of Pharmacology, Mechoulam and his co-authors wrote that their synthetic compound, the methyl ester of cannabidiolic acid (called HU-580 in the paper), could being more effective than existing remedies at CBD, making it "a potential drug treat some nausea and anxiety disorders. These initial clinical tests showed that the acids gave results equivalent to or even superior to the existing treatments, without the side effects.
The CBD acid (CBDA) of natural origin, but unstable, is a thousand times more potent than CBD to bind to a particular serotonin receptor believed to be responsible for alleviating nausea and causing l & # 39; anxiety.
"It's an interesting molecule that has no potential side effects," said Dan Peer, executive director of the Center for Translational Medicine and director of the Center for Research on Cancer Biology at Tel Aviv University.
"It works like a steroid. If it does not have any adverse effects, you have a substitute, which is great, "said Peer, citing the results of tests he had done on cannabis acids and inflammatory bowel disease.
Ziva Cooper, Research Director of the UCLA Cannabis Research Initiative, said EPM research confirms what many people in the field have been suspecting about cannabis acids for a long time, but could not confirm it. because of their instability.
"Their work is quite innovative and relies heavily on what we know about the potential therapeutic effects of cannabinoids," Cooper said, adding that the compound could be particularly effective for pain control. Cooper said that although more testing is needed to determine the effectiveness and safety of humans, the EPM results so far are "quite encouraging."
While the US government plans to spend $ 3 million on CBD research, veterans of the pharmaceutical industry continue to pray for caution, while giving insight into why more drugs do not were built with cannabis compounds.
"People still make fun of marijuana use," said David Campbell, consulting firm partner Oliver Wyman and EPM advisor, who has over two decades of experience in the pharmaceutical industry.
Campbell said such anecdotal evidence is "far" from being able to convince a research committee or shareholders of the effectiveness of cannabis to treat a condition.
"The drugs produced are just not powerful enough," said Peer, referring to CBD, THC and other non-acidic acids.
These factors, in addition to social mores, have all led to a situation where pharmaceutical companies have not been a major presence in the development of cannabis.
"Lilly is not engaged in cannabis research and does not plan to be in the future," wrote Nicole S. Herbert, spokeswoman for the pharmaceutical giant Eli Lilly, in an email.
Sally Beatty, spokesperson for Pfizer, said the company had "dropped" its cannabis-related patents after stopping research on treating cancer and inflammatory pain.
"Years ago, we studied a class of compounds that may have therapeutic value in the treatment of cancer pain and inflammatory pain. Our work in this area has been confined to the laboratory, never tested on patients and finally interrupted, "said Beatty. GSK and Sanofi declined to comment and several other people did not respond to inquiries on the subject of NBC News.
EPM, co-founded by Reshef Swisa, 37, has managed to stabilize the acid version and standardize the process in order to maintain consistent production – a key for the pharmaceutical industry, which has it up to here largely maintained at a distance from the factory despite a strong increase in popularity in CBD-based products.
EPM, which has a patent approved for its processes and 13 others under revision, adopts a new commercial approach to its product, offering to offer its active pharmaceutical ingredient, the key element of a drug, to pharmaceutical companies under Licence. They plan to offer exclusivity for specific medical conditions.
"We are not a drug developer," said Swisa. "We are a developer of molecules."
Swisa said the first applications would likely be to treat psoriasis in a topical cream. Other promising results suggest that the active ingredient could be effective in treating inflammation leading to arthritis, anxiety and inflammatory bowel disease.
Swisa and Mechoulam said they hoped the first applications of their compound would enter Phase 1 FDA testing in six to twelve months, although several commercial and scientific factors may affect this schedule.
These developments come at a time when Big Pharma is besieged by US Attorneys General following the opioid crisis, which could open the door to exploring alternatives for the treatment of pain.
Although the first tests on the Mechoulam compound are promising, Peer strongly recommends that you exercise caution not to wait for an immediate product.
"There is a gap between an interesting molecule and a pharmaceutical product," said Peer.
The average time needed for a drug to get FDA approval is 12 years, according to a 2016 University of Washington study published in Elsevier, although the agency has four tracks accelerated.
While research is expected to continue in the long term, Mechoulam has asked the scientific community to take into account now.
"We could have helped many children with cannabidiol for many years," he said, lamenting decades of delay in accepting his findings.
"I hope this will not happen with the new compound."
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