Shahid Akhter, editor, ETHealthworld spoke to Manit Patel, Chief Executive Officer and Co-Founder, Akseera Pharma Corp to know about the Cannabinoid market and the potential of CBD as a therapeutic which can instill confidence in prescribing by physicians and patients alike.
What is lab-based CBD and how is it different from Cannabis?
Cannabis is a plant that comprises three species Cannabis Sativa, Cannabis Indica, and Cannabis Ruderalis. Cannabinoids are the individual molecules in the Cannabis plant. There are two major Cannabinoids (Cannabidiol- CBD and Tetrahydrocannabinol-THC) and many other minor Cannabinoids, classified as such, based on their relative compositions.
How is Akseera Pharma Corp working in this space?
Akseera Pharma Corp is creating lab-based Cannabinoids, both major and minor, through the processes of organic synthesis with the Institute of Chemical Technology (ICT), India, and biosynthesis at the University of Waterloo (UW), Canada. Lab-based Cannabinoids ensure purity, quality, high yields and overcome challenges associated with growing the plant. It allows the selection of specific Cannabinoids towards treating specific indications.
It is a responsible, science-driven, innovative company that intends to bring ingenious solutions that address unfulfilled medical needs globally. The company provides patients scientifically proven dosage formulations by applying a pharmaceutical approach. Akseera Pharma Corp caters to the global Cannabinoid market and is committed to clinicians, the medical fraternity, consumers, and the community
Given the landmark bill to decriminalize marijuana in US House, where is Cannabis placed in India today?
It is great to see the acceptance that Cannabis and Cannabinoids are getting in the world today. Canada has been at the forefront of Cannabis legalization and other countries are following this including the United State of America. Earlier this month at the United Nations, India voted that Cannabis should be removed from the list of harmful substances which may be indicative of a way forward toward Cannabis decriminalization. We are confident that research and scientific evidence, like ours, will further convince the government of India to see the benefits of Cannabinoids.
As Akseera is the only Indian company that holds requisite permission for Cannabinoid production with Biosynthesis, Organic Synthesis, and Pharmaceutical products, tell us more about the production and participation of Akseera in CBD
Akseera Pharma Corp is a Canadian company with a fully owned Indian subsidiary, holding the permission to conduct research on Cannabinoids. The company scientifically evaluates the therapeutic benefits of Cannabinoids including CBD.
The use of effective and safe active ingredients is a salient feature of pharmaceuticals. To that effect we are developing technology to produce Cannabinoids in the lab (through Organic and Biosynthesis) such that they meet regulatory standards of safety and efficacy. Our technology is directed to make Cannabinoid production in the lab efficient, scalable, affordable and overcome some inherent challenges associated with growing Cannabis including reduction in environmental impact.
Most importantly, our process will put Cannabinoids (including CBD) in the same light as any other pharmaceutical active ingredient ensuring that high quality and pure Cannabinoids can be used by patients as a treatment for their unmet medical needs.
Akseera research in collaboration with Simon Fraser University (SFU) Canada shows that CBD may be beneficial in preventing cardiac arrythmias in hyperglycemic conditions even in Covid-19 infections. In addition, our collaborative projects at University of Waterloo indicate that CBD may have antiviral properties and potentially be useful to treat and prevent Covid-19. In fact, our research has uncovered a novel mechanism of action of CBD; opening a myriad of possibilities for its uses in pharmaceuticals.
How is producing lab-based cannabinoids different from growing cannabinoids?
The ability to manufacture Cannabinoids, using biotechnology and genetic engineering, enables us to access commercial quantities of both major and minor Cannabinoids in their purest form as Active Pharmaceutical Ingredients (APIs).
When growing the Cannabis plant, there are chances that it may produce some chemicals like Tetrahydrocannabinol (THC) is famous for its intoxicating and euphoric properties. However, lab-based Cannabinoids can enable the manufacturing of a single Cannabinoid without the intoxicating components of the plant, further reducing the already low abuse potential.
Lab-based cannabinoids have several advantages over Cannabinoids extracted from the plant. They offer a safe, affordable, more environmentally friendly alternative to produce APIs for the Cannabinoid based pharmaceuticals. Most importantly, they offer the ability to select individual Cannabinoids specifically beneficial towards treating different indications, while eliminating others that may induce unwanted side-effects. Further, it enables efficient production of minor Cannabinoids, which are present in quantities of less than 1% of the plant and are difficult and inefficient to extract.
Lab-based cannabinoids can be translated into large scale production while meeting quality standards set for the Pharma, Food, Beverage, and legal recreational industries while making the products scalable and affordable. Lab-based cannabinoids also address the challenges posed in obtaining Cannabinoids through extraction from the plant. Unlike growing Cannabis to extract Cannabinoids, lab-based cannabinoids do not result in loss of habitats, large carbon footprints, excessive use of water or energy, and volatile organic compounds running into water bodies.
How do you see the growth of the cannabidiol market for therapeutic use in India and Canada?
The therapeutic value of Cannabinoids for the global market, is being uncovered, and Akseera has been heavily invested in such research to ensure safety and efficacy of Cannabinoid based pharmaceuticals. While the Canadian market has seen a growth of products containing Cannabidiol, the market is still in its infancy. In India, the market is even less developed than Canada. The potential and requirement for such pharmaceuticals can be deemed unprecedented especially for unmet medical needs. With more systematic research being conducted, the potential of CBD as a therapeutic can be determined and its interactions better understood – which in turn can instill confidence in prescribing physicians and patients alike.
We are only seeing the tip of the iceberg of Cannabinoid-based pharmaceuticals, which is anticipated to grow, not only in India and Canada, but also globally.
In your opinion what are the current challenges faced by this industry?
Empirical evidence suggests the therapeutic benefits of Cannabis. However, Cannabis is also stigmatized as an illicit drug, due to prohibitions. This is a major challenge in the minds of consumers. In addition, and more importantly the formulations that are available in the market are either not approved by regulatory authorities and therefore, healthcare practitioners are not convinced of the benefits of Cannabinoids. The place of Cannabinoids in the pharmaceutical space needs to be clarified and determined based on scientific evidence to ensure that Cannabinoids can exist in mainstream pharma. We, at Akseera, are heavily invested in research on the molecular interaction of Cannabinoids in the human body, as we would do with any other pharmaceutical medicine, to understand the therapeutic value, interactions and counter-indications of products we develop. We believe such well-studied and understood products instill confidence in healthcare professionals who prescribe and patients who consume our products.
How does your current research on CBD act as a prophylactic against pro-arrhythmic effects in COVID patients? What are the results so far?
Akseera’s research at Simon Fraser University has unraveled a novel mode of action of CBD which shows promise in rescuing cardiac cells from arrhythmias and potential cardiac arrest. Our investigations so far support the hypothesis that CBD can rescue cardiac arrhythmias in hyperglycemic conditions and those caused by some Covid-19 treatments like Azithromycin. Although not mandated for clinical trials, we are currently testing our candidate in human cells lines to see if there are other potential benefits in human cardiac cells.
Additionally, our research project at University of Waterloo, Canada, shows promise of Cannabinoids, including CBD in prophylaxis and treatment for Covid-19. This is due to slowing viral replication and spread within the host, potentially “buying time” for the immune system to respond and clear the infection.
How do these research results impact the Covid scenario in India and bring down the treatment cost?
We have some ongoing research, at the University of Waterloo and Simon Fraser University in Canada, which indicating molecular interactions of CBD such that it may help prevent and treat Covid-19. Our pro-arrhythmic effects of CBD can improve outcomes of existing Covid-19 treatments enhancing safety and potentially effectiveness of vaccines by reducing side effects.
Further, given our results, there is a potential for Cannabinoids to improve outcomes for seniors and susceptible patient population and reduce the burden on hospitals and healthcare systems due to safe, at home, treatment options.
Repurposing of critical drugs has shown hope and benefits. Please tell me how repurposing and using CBD as adjuvant also helps in preventing or managing Covid?
CBD fits the bill of a candidate drug for repurposing owing to the following – Affordability, High Safety Profile – it is USFDA approved for use in children; Clear Clinical Data on benefits if used in other treatments; Efficacy in low dosage; Knowledge of drug-drug interaction; Minimum risks to patients across age groups; Understanding long-term effects; Tracking prescription data and patient monitoring; Ease of use in non-hospital setting; Mass manufacturing. To summarize repurposing CBD is an opportunity to evaluate a potential affordable Covid-19 treatment with quicker approval times.