VANCOUVER - InMed Pharmaceuticals Inc. ('InMed' or the 'Company') (TSX: IN; OTCQX: IMLFF), a clinical stage biopharmaceutical company developing therapeutics targeting diseases with high unmet medical needs, today revealed the rare cannabinoid cannabinol ('CBN') as the active pharmaceutical ingredient ('API') in its two product candidates under development: INM-755 for epidermolysis bullosa ('EB') and INM-088 for glaucoma.
InMed is leading the way in the clinical development of CBN to treat human disease.
'We are proud to be the first company to investigate cannabinol's therapeutic potential in human clinical trials,' commented InMed CEO, Eric A. Adams. 'InMed has completed more than 30 preclinical pharmacology and toxicology studies, identifying potential therapeutic advantages of CBN in specific disease models over the more common cannabinoids THC and CBD, as well as other rare variants.' Mr. Adams continued, 'We are simultaneously exploring innovative biosynthetic manufacturing methods and therapeutic applications of CBN formulations to target diseases with high unmet medical need.'
InMed's scientific team today officially revealed CBN as the API in INM-755 at the EB2020 World Congress in London, UK, where they will also exhibit preclinical data in support of the INM-755 program in EB.
INM-755 is being developed as InMed's lead dermatological product candidate for the treatment of symptoms related to EB, a rare genetic skin disease characterized by fragile skin that can lead to extensive wounds and blistering. INM-755 is formulated as a CBN-based topical cream. In addition to relief of symptoms, including inflammation and pain, InMed believes INM-755 may enhance skin integrity in a subset of EB Simplex patients. Following regulatory and ethics committee approval in December 2019, InMed initiated a Phase 1 clinical trial for INM-755 in healthy volunteers.
CBN is also the API in InMed's second product candidate, INM-088, being investigated as a potential treatment for ocular disease. INM-088 is in preclinical testing and advanced formulation development with an aim to decrease intraocular pressure and provide neuroprotection for individuals suffering from glaucoma.
Both INM-755 and INM-088 are designed for topical administration at the disease site, seeking to avoid potential side effects related to systemic exposure. InMed has filed patents to protect its use of CBN and other rare cannabinoids to treat these and other potential diseases, as well as patents directed towards our proprietary biosynthesis platform.
InMed Pharmaceuticals is a clinical stage biopharmaceutical company developing a pipeline of cannabinoid-based medications that target diseases with high unmet medical need. The Company is dedicated to delivering new therapeutic alternatives to patients that may benefit from cannabinoid-based medicines.
About Cannabinol ('CBN')
CBN is a rare cannabinoid with unique physiological properties that may result in distinct therapeutic and safety characteristics relative to the more commonly known cannabinoids tetrahydrocannabinol ('THC') and cannabidiol ('CBD'). CBN occurs naturally in the cannabis plant, but typically only in trace quantities. InMed Pharmaceuticals is exploring the therapeutic potential of CBN in diseases with high unmet medical need, while also developing a proprietary biosynthesis platform to economically produce pharmaceutical-grade cannabinoids at commercial scale.
INM-755 is a proprietary, topical, cannabinol-based cream product candidate intended as a topical therapy to treat epidermolysis bullosa (EB) and potentially other dermatological disease indications. Preclinical data demonstrate that INM-755 may help relieve hallmark EB symptoms, such as inflammation and pain, as well potentially restore the integrity of the skin in a subset of EB Simplex patients.
About Epidermolysis Bullosa ('EB')
EB is the collective name of a group of genetic disorders of connective tissues affecting individuals from birth and is characterized by fragile skin that is easily damaged, leading to extensive blistering and wounding. The blisters may appear in response to minor injury, even from heat, rubbing, scratching or adhesive tape. The disease has no definitive cure and all currently used treatments are directed towards symptom relief.
InMed is developing INM-088 as a cannabinol ('CBN') eye drop formulation targeting reduction of the intraocular pressure associated with glaucoma as well as being designed to serve as a neuroprotectant to the retinal ganglion cells.
Glaucoma is a group of eye conditions characterized by abnormally high pressure in the eye, which can damage the membranes of the retina and the head of the optic nerve, leading to blindness. Glaucoma is the second leading cause of blindness worldwide and can occur at any age but is more common in older adults.
Cautionary Note Regarding Forward-Looking Information
This news release contains 'forward-looking information' and 'forward-looking statements' (collectively, 'forward-looking information') within the meaning of applicable securities laws. Forward-looking information is based on management's current expectations and beliefs and is subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Forward-looking information in this news release includes statements about: leading the way in the clinical development of CBN to treat human disease; CBN having potential therapeutic advantages in specific disease models over certain cannabinoids; exploring innovative biosynthetic manufacturing methods and therapeutic applications of CBN formulations to target diseases with high unmet medical need; INM-755 being able to treat symptoms related to EB and potentially other dermatological disease indications; INM-755 enhancing skin integrity in a subset of EB Simplex patients; INM-088 being developed as an eye-drop to potentially treat ocular disease by decreasing intraocular pressure and providing neuroprotection; INM-755 and INM-088 minimizing potential side effects related to systemic exposure; developing a proprietary biosynthesis platform to economically produce pharmaceutical-grade cannabinoids at commercial scale as well as a pipeline of cannabinoid-based medications that target diseases with high unmet medical needs.
With respect to the forward-looking information contained in this news release, InMed has made numerous assumptions regarding, among other things: continued and timely positive preclinical and clinical efficacy data; the speed of regulatory approvals; the effectiveness of patent protection; demand for InMed's products and continued economic and market stability. While InMed considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies.
Additionally, there are known and unknown risk factors which could cause InMed's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information contained herein. Known risk factors include, among others: INM-755 may not produce the desired effects; InMed may not be able to advance its other product candidates, such as INM-088, on a timely basis, or at all; regulatory filings may not be filed or approved on a timely basis, or at all; patent protection may not be sufficient to protect InMed's intellectual property; clinical trials may not proceed as anticipated; economic or market conditions may worsen; InMed's proprietary biosynthesis manufacturing process and drug development programs may not deliver the expected level of results and InMed may not be able to provide new therapeutic alternatives that benefit patients via cannabinoid-based medicines. A more complete discussion of the risks and uncertainties facing InMed is disclosed in InMed's most recent Annual Information Form and other continuous disclosure filed with Canadian securities regulatory authorities on SEDAR at www.sedar.com.
All forward-looking information herein is qualified in its entirety by this cautionary statement, and InMed disclaims any obligation to revise or update any such forward-looking information or to publicly announce the result of any revisions to any of the forward-looking information contained herein to reflect future results, events or developments, except as required by law.