Biosynthesis Could Reduce Regulatory Hurdles for Cannabis Researchers
September 7th, 2017
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The medical marijuana movement has made tremendous progress across the United States, but acceptance in the medical community is an entirely different story. While the FDA has approved a handful of drugs containing synthetic cannabinoids, the agency has never approved a product derived from botanical marijuana. Critics argue that synthetic cannabinoids miss the so-called entourage effect, while supporters argue that botanical marijuana isn’t standardized.
In this article, we will look at InMed Pharmaceuticals’ (CSE: IN) (OTCQB: IMLFF) biosynthesis program and how it could address many of these issues.
The Industry’s Problem
Medical marijuana is legal in an increasing number of states, but the drug is a Schedule I Controlled Substance on a federal level. Many citizens have access to medical marijuana through dispensaries, but pharmaceutical companies have experienced an uphill battle bringing cannabinoid-based products through clinical trials. And, the medical community is hesitant to recommend anything that hasn’t undergone rigorous clinical trials to prove safety and efficacy.
So far, the FDA has only approved synthetic cannabinoids, like Marinol and Cesamet, for the treatment of AIDS and chemotherapy symptoms. The agency has never approved a product derived from botanical marijuana because sourcing drug compounds made with reliable, reproducible and well controlled processes has been a challenge. Some companies have started to begin Phase I and II clinical trials outside of the U.S. with plans to bring Phase III clinical trials back into the country when ready.
A quote from Senate testimony by the FDA’s Douglas Throckmorton in 2016 highlights the problem from a regulatory perspective. Mr. Throckmorton stated that, in order to obtain FDA approval, drug manufacturers “must demonstrate that they are able to consistently manufacture a high-quality drug product. This is an essential part of drug development and presents special challenges when the drug is derived from a botanical source, such as marijuana…. If there is any future for marijuana as a medicine, it lies in its isolated components, the cannabinoids and their synthetic derivatives.”
An Innovative Solution
InMed Pharma has developed a robust, high-yield biosynthesis process for manufacturing all 90+ naturally-occurring cannabinoids. The process combines the inherent safety and known efficacy of natural drug structures with the convenience, control, and quality of a laboratory-based manufacturing process. In other words, the process is merging the entourage effects of the botanical drug with the need for consistency and accuracy within the medical community.
There are several benefits to biosynthesis as a strategy:
- Significant cost savings and scalability compared to traditional growing and extraction methods.
- Enhanced quality control, purification, and production relative to growing and extraction methods
- Access to minor cannabinoids that are economically unfeasible to extract from plant sources and develop into drug candidates.
- Provides cannabinoids that are bioequivalent to the naturally-occurring products (very difficult to achieve using a chemical synthesis process).
The company’s process works by inserting the plant’s DNA into an E. coli bacteria that has the internal biology to manufacture (express) the cannabinoid compounds. This process is similar to the way that insulin is produced on a massive scale to help millions of diabetics around the world. By using this process, the company avoids the need to grow the plant, extract cannabinoids, and then purify those cannabinoids. The company instead provides direct access to only the cannabinoid compounds that are desired.
InMed Pharmaceuticals’ (CSE: IN) (OTCQB: IMLFF) biosynthesis platform represents an innovative solution to the cannabis industry’s core problem of conducting research on U.S. soil. By taking an approach similar to the way insulin is mass produced, the company is capable of generating specific cannabinoids on a scalable and affordable level, while ensuring that they’re both highly purified and bioidentical to what the cannabis plant makes.
In addition to this solution, the company has developed a comprehensive drug discovery platform focused on bringing therapeutics to market. The bioinformatics platform uses algorithms to assess the different active sites on cannabinoids and screen them against approved drug structures, disease site receptors, genetic profiles, and other pathways to select specific cannabinoid combinations that may play an important role in treating diseases with high unmet medical needs.
The company’s lead clinical program is INM-750- targeting epidermolysis bullosa (EB), which is a medical condition with no approved treatments. The therapy has several mechanisms of action to deliver symptomatic relief, including accelerated wound healing, pain reduction, itch reduction, reduced inflammation, and antimicrobial activity. The therapeutic may also re-establish the epidermal-dermal junction by upregulating certain keratins, possibly reversing the disease in some patients.
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