InMed Releases CBN Preclinical Results in Glaucoma

VANCOUVER, May 27, 2020 /PRNewswire/ - InMed Pharmaceuticals Inc. ("InMed" or the "Company") (TSX:IN; OTCQX:IMLFF), a clinical-stage pharmaceutical company developing medications targeting diseases with high unmet medical need and leading the way in the clinical development of cannabinol ("CBN"), today provided an update on the preclinical results from its INM-088 drug development program that indicate a potential neuroprotective effect of cannabinol ("CBN") on nerve cells located in the eye. INM-088 is being developed as a potential treatment option for ocular diseases, such as glaucoma, where neuroprotection may provide an added therapeutic benefit.

The first in vitro preclinical study evaluated the neuroprotective effects of several individual cannabinoids, including CBN, tetrahydrocannabinol ("THC") and cannabidiol ("CBD"), on differentiated retinal ganglion cells, or "RGCs", that form a thin layer of neurons responsible for relaying visual signals in the eye. This particular study examined the effects of cannabinoids on RGCs under normal atmospheric pressure and elevated pressure conditions as a model of raised intraocular pressure ("IOP"), a key characteristic of glaucoma. Elevated pressure mimicking high IOP had a cytotoxic effect on the RGCs. However, the combination of CBN and elevated pressure, within the same time period, resulted in a high level of cell survival in a dose dependent fashion. CBN was superior to both CBD and THC under identical testing conditions. This data indicates a potential neuroprotective effect of CBN in ocular disease.

Next, using the same in vitro model described above, InMed examined the potential effect of CBN on reducing or preventing natural RGC cell death, or apoptosis. Data indicate that CBN has a significant anti-apoptotic effect on differentiated RGCs subjected to elevated pressure conditions. Exposure of RGC to high pressure for a period of 6 hours led to apoptosis ranging from 30-60%, whereas the addition of CBN resulted in a significantly higher level of cell survival.

Elevated IOP in glaucoma is often attributed to decreased aqueous humor outflow through the trabecular meshwork ("TM") of the eye. Additionally, the cytokine TGF-β2 has been found to be aberrantly elevated in correlation with increased TM outflow resistance. Therefore, the Company evaluated CBN exposure to primary TM cells under these simulated glaucoma condition through either increased pressure conditions or by elevating TGF-β2. TM cells exposed to CBN under a range of conditions, including normal pressure or elevated pressure or TGF-β2 exposure, for a duration of 72 hours, demonstrated deceased expression of protein markers associated with reduced TM outflow. These results suggest that CBN may have potential to reduce IOP through improvement in the aqueous humor outflow in the TM.

InMed also conducted several in vivo experiments to understand the pharmacokinetics and effect of CBN in the eye. The first of these studies was designed to specifically measure CBN levels in the eye and plasma following direct bilateral intravitreal ("IVT") injection into the fluid of the central cavity of the eye. Following IVT delivery, systemic plasma levels of CBN were found to be below detectable limits, whereas CBN levels in the eye were shown to persist for an extended period of time with a projected half-life (t_1/2) of approximately 33 hrs. These results present the prospect of high CBN localization at the site of intended treatment.

In addition, InMed conducted an in vivo efficacy study to evaluate neuroprotective and IOP lowering effects of CBN following IVT injection in the recognized episcleral vein laser photocoagulation model for glaucoma.  Biological function of the neurons was assessed through pattern electroretinogram ("pERG") measurement of neuronal electrical activity in response to light. Results demonstrated reduced IOP and improvement of pERG function when CBN was delivered by IVT injection after episcleral laser photocoagulation.

"Results from these preclinical in vitro and in vivo studies, which also served as the basis for our recently filed PCT patent application, highlight the potential for CBN to contribute an independent neuroprotective effect in addition to the standard IOP reduction approach to treating glaucoma," remarked Dr. Eric Hsu, InMed's Senior Vice President of Preclinical Research and Development. "We are now well positioned to advance towards selection of a suitable topical formulation for CBN delivery to the eye and anticipate commencing IND-enabling toxicology studies with INM-088 in the latter half of 2020".

About InMed: InMed Pharmaceuticals is a clinical-stage pharmaceutical company developing a pipeline of cannabinoid-based medications, initially focused on the therapeutic benefits of cannabinol (CBN) in diseases with high unmet medical need. The Company is dedicated to delivering new therapeutic alternatives to patients that may benefit from cannabinoid-based medicines. For more information, visit www.inmedpharma.com.

About INM-088: 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 (RGC) and the optic nerve.

About Glaucoma: 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. As of 2010, there were 44.7 million people in the world with 'open angle' glaucoma, the most common form of the disease, of which 2.8 million were in the United States. By the end of 2020, the prevalence is projected to increase to 80 million worldwide with 3.4 million the United States.

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, but is not limited to, statements about: leading the way in the clinical development of cannabinol ("CBN"); that INM-088 may have a potential neuroprotective effect of cannabinol ("CBN") on nerve cells located in the eye; that INM-088 may be a potential treatment option for ocular diseases, such as glaucoma, where neuroprotection may provide an added therapeutic benefit; CBN having a significant anti-apoptotic effect on differentiated RGCs subjected to elevated pressure conditions;  that CBN may have the potential to reduce intraocular pressure ("IOP") through improvement in the aqueous humor outflow in the trabecular meshwork; the potential for high CBN localization at the site of intended treatment; the potential for CBN to contribute an independent neuroprotective effect in addition to the standard IOP reduction approach to treating glaucoma; the selection of a suitable topical formulation for CBN delivery to the eye; commencing IND-enabling toxicology studies with INM-088 in the latter half of 2020; INM-088 reducing IOP associated with glaucoma as well as being designed to serve as a neuroprotectant to the retinal ganglion cells (RGC) and the optic nerve; developing a pipeline of cannabinoid-based medications in diseases with high unmet medical need; and delivering new therapeutic alternatives to patients that may benefit from cannabinoid-based medicines.

With respect to the forward-looking information contained in this news release, InMed has made numerous assumptions regarding, among other things: the ability to recruit appropriate test subjects; 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: the outbreak and impact of COVID-19 may worsen; INM-088 may not proceed with the anticipated benefits, timeline and structure, or at all; InMed may not be able to advance its other product candidates on a timely basis, or at all; regulatory filings may not be filed or approved on a timely basis, or at all; 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.

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SOURCE InMed Pharmaceuticals Inc.