Business update and upcoming milestones:
INM-755 – Phase 2 clinical trial in the treatment of Epidermolysis Bullosa
To date, the Phase 2 clinical trial has enrolled 16 patients of its targeted 20 patients. Several additional prospective patients have been identified for screening at the clinical sites; therefore, the Company decided to extend the enrollment period to the end of March 2023. The clinical trial is evaluating the safety of INM-755 cannabinol cream and its preliminary efficacy in treating symptoms of itch, pain, and wound healing in patients with epidermolysis bullosa. As the trial is double blinded, InMed will remain blinded to INM-755 treatment outcomes until the last patient has completed treatment and the database is locked and analyzed.
INM-088 – Advancing towards human trials
The Company continues to conduct the required preclinical work, including toxicology studies, and has planned several GLP studies in 2023 in advance of human clinical trials. Outcomes from our pre-IND meeting with the FDA in 2022 provided important feedback on our proposed preclinical studies and for the design of human clinical trials. Advancing to human trials in a disease indication with a very large patient population like glaucoma will be a significant development for the Company. We are on track to begin this clinical trial in 2024.
INM-900 – Developing a new approach in neurodegenerative disease
Cannabinoids are known to be highly lipophilic and can cross the blood brain barrier, making the non-psychedelic cannabinoids attractive pharmaceutical agents for targeting neurological disorders. Our pipeline was expanded this year with the addition of our neurodegenerative disease program. With recent promising preclinical data, InMed plans to expedite its INM-900 program for the potential treatment of neurodegenerative diseases such as Alzheimer’s Disease, Parkinson’s Disease, and Huntington’s Disease. Our research demonstrated the neuroprotective effects of specific cannabinoid analogs and their potential to improve neuronal function. Two cannabinoid analogs are being assessed in in vivo models of neurodegenerative disease. Our approach may target multiple novel disease pathways versus the majority of drugs currently in clinical development for these diseases.
Novel cannabinoid analogs – protecting the R&D investment
InMed continues to develop a valuable library of novel, proprietary cannabinoid analogs. These analogs are being selectively screened and developed for targeting specific disease outcomes, safety profiles, and/or pharmacological properties such as improved delivery. In addition, these novel cannabinoid analogs are patentable, increasing their commercial attractiveness for internal development or as licensing candidates to other drug development companies.
BayMedica commercial business
Our efforts in the first half of 2022 were primarily focused on advancing the commercial side of the business following the acquisition of BayMedica in late 2021. Although BayMedica continues to be a reliable source of rare cannabinoids, demand has not accelerated as quickly as anticipated for a variety of reasons. As we enter 2023, we will continue to evaluate strategic options and long-term supply agreements for this business segment. In 2022, BayMedica supplied highly pure rare cannabinoids for use in Radicle Science, Inc.’s Radicle Energy rare cannabinoid study to assess the effects of delta-9 THCV on energy, focus/attention, appetite and weight/body mass index (BMI). The study is part of Radicle Science’s large-scale evaluations of several rare cannabinoids, involving up to 10,000 participants in total. The consumer-driven trial is complete and results are expected in the first half of 2023, providing much needed supportive data to demonstrate the effects of delta-9 THCV.
Business development
The Company continues to evaluate and pursue business development opportunities which align strategically with the Company’s current direction and pharmaceutical programs.
In light of current capital market challenges, the Company’s main priority is to continue to adequately resource the Company’s activities while maintaining a healthy balance sheet. With the completion of recent financings and depending on how we prioritize investment into our various development activities, InMed has a projected cash runway into early 2024, allowing the Company to hit certain material milestones over the coming year which we believe will increase shareholder value.
Management looks forward to updating shareholders over the coming months.
