The US Patent and Trademark Office (USPTO) has granted Axim a patent for its extraction and purification process of Delta-9-tetrahydrocannabinol (THC) – a cannabinoid molecule derived from medicinal cannabis.
“This is a big breakthrough for the industry and our programmes specifically as we plan to expand our IP [intellectual property] beyond just THC and use these molecules in our drug candidates as we seek regulatory approval in the US, Europe and beyond,” said CEO George Anastassov.
According to Axim, the successful patent application 15/146,668 – submitted to the USPTO in 2015 – enables a more efficient and cost-effective method compared to the industry standard.
“Even with regulatory approval, drugs must be made from consistent and pure APIs [active pharmaceutical ingredients] which are hard to derive from cannabis plants. These APIs must be produced according to cGMP [current good manufacturing practice] principles and currently, there are no such processes for naturally extracted cannabinoids,” Anastassov told us.
“Other processes currently in use are very extensive and expensive, some with more than 50 steps," he added.
“Our now patented process is extremely efficient, taking about 5 steps, and effective at producing nearly pure molecules.”
MedChew for MS
The firm eventually plans to use these patented methods to extract THC for its MedChew RX clinical programme. MedChew RX is a gum containing 5mg cannabidiol (CBD) and 5mg THC, which aims to treat pain and spasticity in patients with multiple sclerosis (MS).
“Axim hopes to use this process to produce APIs for use in its current programme, however, due to the fact that a sterile, large-scale facility is required, Axim will continue to source its APIs from other providers until the time we are able to open our own facility,” said Anastassov.
“Axim will not license the technology at this point, but may look at that depending on the aforementioned,” he added.
The firm has also already instigated a clinical trial programme for CanChew+ – CBD-based controlled release chewing gum designed to reduce irritable bowel syndrome symptoms and improve patients’ perceived welling.