Can Therapix break new ground in the medical marijuana market with its THC-infused weapon against Tourette’s Syndrome?
With technologies in hand that look to simulate the positive effects of marijuana, Israel-based Therapix Biosciences, an Israeli pharma cannabis company looking to treat patients suffering from Tourette syndrome and patient with mild cognitive conditions that might lead to Alzheimer’s.
“We are pretty traditional and conservative in our approach. We are trying to use the active ingredient — pharmaceutical cannabinoids,” Therapix CEO Dr. Elran Haber told Geektime, “an FDA-approved compound that is found in plants but is not the actual plant. It’s a synthetic form of the same active ingredient and molecules.”
When Therapix announced in June they would license a nasal-delivery form of the cannabinoid concoction from the Hebrew University’s tech transfer arm Yissum, they also let it be known that they had applied for the FDA to request for Orphan drug designation for Tourette’s-fighting product: THX-TS01. In Dr. Haber’s eyes, Therapix has been taking a more standard pharmaceutical approach, adding only FDA-approved ingredients like dronabinol, and synthesizing it to match chemical properties that are found in THC to treat the pain and illnesses that the company is focusing on.
At a recent science conference focused on Cannabinoids research , Therapix shared a discovery made by Tel Aviv University Professor Yosef Sarne. Dr. Haber explains, “He (Sarne) was able to demonstrate that if you are using a very low dose of THC, you can obtain the opposite effect, improving cognitive ability and reversing memory decline in mice.”
That study, published in the journal Experimental Brain Research, stated that, “the positive effect of THC in mice lasted for at least seven weeks,” and concluded that a “an ultra-low dose of THC can modify brain plasticity and induce long-term behavioral and developmental effects in the brain.”
Despite this observation, only very few THC and other marijuana-extracted elements have been approved as “a safe and effective drug for any indication” by the FDA. Therapix believes that have found a way to obtain the FDA approval by incorporating a synthetic form of THC called dronabinol. Dronabinol, also known by the brand name Marinol, was approved in the mid-1980s to treat cancer patients for severe nausea during chemotherapy. Dr. Haber says extracting elements from the original plant makes the FDA’s approval grant harder to obtain.
In addition to following standard FDA procedure for approval of products, Dr. Haber believes the potential market value of medical marijuana will help garner more interest from major pharma companies.
“The medical cannabis market is about $2 billion a year and can reach up to $8 billion a year. This is only the medicinal part of cannabis,” Dr. Haber told Geektime. “The size of the market for legal marijuana in the United States is projected to grow to $7.1 billion in 2016, according to a report by New Frontier and ArcView Market Research.
Cutting into other people’s territory?
On the other hand, not everyone in the medical cannabis industry is optimistic about a smooth approval process from major pharma companies and regulators. Saul Kaye, CEO and founder of both iCAN and cannabis networking conference CannaTech, advocates the use of traditional marijuana for medical purposes. But cannabis companies are finding it difficult to access the funding necessary to move forward, something Kaye places at the feet of those same companies because, in a manner of speaking, they fear it could undermine the profitability of their other pain-treating products.
“One of the difficulties there is that, intrinsically, clinical trials are done by pharmaceutical companies to maximize a product profit, but cannabis’ ability to reduce dependence on pharmaceutical products is innately at odds with a pharmaceutical company approach, so we’re not seeing innovation dollars on medical trials coming in from traditional sources,” Kaye told Geektime.
He views marijuana in its original form as a highly effective solution to combating neurological pain and illnesses, but more research is required in order to understand the proper dosage and its effects.
“ALS, Parkinson’s, neuropathic pain, fibromyalgia [and] epilepsy are going to be treatable with cannabis,” Kaye continued, “but we need a lot of research to understand how it works. What are the mechanisms of action?What is the right dosage? What is the right delivery method?”
However, Dr. Haber thinks Therapix has already discovered the right dosage and right delivery method. In their approach, Therapix is taking a stand on the debate over whether the industry should adopt a synthetic model that is far more accurate in so far as producing products that are of a consistent strength and quality. As the medical field looks to cannabis for solutions, doctors are far more likely to adopt methods of delivery that can be easily measured and prescribed. In its organic form, each “batch” of buds are far more likely to come out slightly different from one another, due to factors that are inherent to them being naturally grown plants. By turning to synthetics, the producers should have a higher degree of control that is likely to impress doctors and regulators alike. It is far easier to tell a patient to take two sprays a day from a nasal prescription, than say one joint in the evening.
“We believe, that through the technology for the nasal administration of the drug, we will be able to improve the bioavailability and efficacy, while shortening the reaction time and enhancing the safety profile of the active ingredient THC for treatment of the indications on which the company is focused.” Dr. Haber said in a statement at the time.
In contrast to Kaye’s reasoning, Dr. Haber thinks that in some industries, leaders will eventually incorporate marijuana into their line of products.
“I think that it’s a matter of time until they will start working with cannabinoids and other compounds/components in the pharmaceutical industry,” Dr. Haber emphasized to Geektime. “I think they will try to find products like ours or different approaches that could enable them to maintain their pharmaceutical characteristics and be for example [a] solution to overusing of opioids…that eventually companies in the U.S. that are selling opioids will get into this space eventually.”