On 10-11 October 2018, investors, industry stakeholders, and senior executives from the life sciences community will gather in Boston, Massachusetts, for the inaugural LSX World Congress USA. The two-day event will feature a number of panel discussions and fireside chats examining the current state of the financing and partnering ecosystem, as well as the latest innovations in the sector.
On the afternoon of 11 October, an executive and investor panel will explore the potential of cannabinoid-related therapies and recent developments in the field. The panel, Seeking High Returns with Cannabinoids, will feature: Dean Petkanas, Chief Executive Officer at Kannalife Sciences; Greg Gorgas, President and Chief Executive Officer at Artelo Biosciences; Karan Wadhera, Managing Partner at Casa Verde Capital; Neil Mahapatra, Chairman at Oxford Cannabinoid Technologies. Ahead of the panel, Artelo Biosciences’ Greg Gorgas (pictured below), shares some initial insights into the company’s focus areas and his perspective on the possibilities presented by cannabinoids and related therapeutics.
Please would you be able to give an overview of Artelo Biosciences’ technology and its applications?
Artelo Biosciences is a clinical stage biopharmaceutical company developing a portfolio of proprietary, small molecule therapeutics targeting the endocannabinoid system (ECS). The company’s programs span three distinct approaches to ECS modulation:
ART 27.13 is a synthetic peripherally restricted, dual CB1/CB2 receptor agonist being developed for treatment of anorexia in cancer patients (approximately 60% of treated cancers). In a Phase 1 study, dose dependent, meaningful increases in body weight were observed over a two-week treatment period. Importantly, chances in body weight occurred at dosages that were well tolerated and free from the CNS side effects typically observed with non-peripherally restricted CB1/ CB2 agonists. Phase 2 studies are planned to begin in 2019.
ART12.11, is a proprietary cocrystal of cannabidiol (CBD), a compound recently approved by FDA (as active ingredient in Epidialex®). Artelo believes its cocrystal solves many of the existing limitations of CBD by reducing physical polymorphisms. Our cocrystal is a single crystalline form with improved pharmaceutical properties. We believe administration of our cocrystal will result in reduced variability in exposure and thus improved tolerability. Artelo is currently scaling up for GMP manufacture and plans to begin clinical studies with ART12.11 in 2019.
ART 26.12 is the lead compound in a series of proprietary, small molecule, FABP 5 antagonists exclusively licensed by Artelo from Stony Brook University. Researchers at Stony Brook were targeting FABP 5 as a mechanism for modulating the endogenous endocannabinoid anandamide. Studies revealed the FABP 5 antagonists also are highly potent inhibitors of the PPARγ / VEGF pathway and prevented the growth and metastasis of highly resistant prostate and breast tumors in well established animal models. Artelo is currently optimizing the chemistry around the current lead and plans to initiate IND-enabling studies for a cancer indication in 2019.
What is the potential of the endocannabinoid system and cannabinoid-related therapies in addressing unmet medical need?
The endocannabinoid system (ECS) comprises one of the largest communication networks in the human body. According to the NIH (2013), “Modulating the ECS activity may have therapeutic potential in almost all diseases affecting humans, including diabetes, neuro- degenerative, inflammatory, gastrointestinal, pain, cachexia, cancer...” The clinical use of cannabinoids is probably best known in treating anorexia in wasting conditions, multiple sclerosis, nausea associated with cancer, and certain forms of epilepsy. Although there are several federally-approved pharmaceutical products that modulate the ECS already available in many countries, we are just beginning to realise the potential of cannabinoid-related therapies in addressing unmet medical needs.
How have you seen research, collaboration and funding within this area develop over recent years?
Participation in scientific meetings, such as the Annual Meeting of the International Cannabinoid Research Society, is at an all-time high and the recent approval of Epidiolex is evidence of the potential of ECS-based therapeutics. However, the chemistry and pharmacology of cannabinoids is highly complex and there are inherent challenges with both plant-based extracts and synthetically produced cannabinoids. Academic researchers have made enormous strides in overcoming these obstacles, yet the rigours of true “pharmaceutical development” have been largely absent from the cannabinoid research community. Artelo believes it can help fill this gap and bring the GLP /GMP /GCP approach to the enormous body of academic work leveraging it into high value products in a cost effective and low risk manner. The key ingredient to this is funding which, although improving, remains inadequate.
What is in store for Artelo Biosciences over the next 12 months? And what is your long-term vision for the company?
Artelo's business model is to develop multiple pharmacological approaches to ECS modulation and related treatment approaches. Artelo plans on meeting with FDA before the end of the year with ART12.11 and hopes to be able to file the IND for the proprietary CBD cocrystal in 2019. The company also expects to initiate a Phase 2 study for ART27.13 in anorexia associated with cancer by this time next year. Artelo’s long-term vision is to advance our product candidates to either a stage where they achieve federal marketing authorisation or partnered with larger pharmaceutical companies with the resources to launch the drugs on a global scale.
What would you like those who attend the Seeking High Returns with Cannabinoids Panel at the LSX World Congress USA to take away from the discussion?
FDA approval of drugs that modulate ECS dates back to the mid-1980s; however, I would like attendees to understand that scientific understanding, research collaboration, and intelligent funding are just now coming together creating the perfect opportunity to realise the vast potential of modulating the ECS. Novel drugs are being developed, new collaborations are being formed, and investors have a unique opportunity to participate in a relatively low risk, high value approach to treating unmet medical needs.
Find out more about the panel discussion and the LSX World Congress USA conference programme here. Join the conversation and stay up to date with the latest event announcements by following #LSXUSA18 and @LSXLeaders.
Read more: Fellow panellist Karan Wadhera, Managing Partner at Casa Verde Capital, provides an overview of the venture capital firm's focus areas and touches on the opportunities and obstacles facing the advance of cannabinoid-related therapies here.
Feature image © Alexey Brin – stock.adobe.com