Company Overview
For personal use only
MedChew™ Rx (CBD and THC)
for Pain and Spasticity in Multiple Sclerosis (MS)
Problem
Up to 84% of people suffering from MS also
experience spasticity, which causes involuntary
muscle stiffness and spasms. Pain is also a
common symptom in MS, with up to two-thirds
of people with MS reporting pain in
worldwide studies.
Solution
MedChew™ Rx is absorbed through the oral
mucosal membrane and bypasses the liver, and
first pass metabolism. No cannabinoid-based drug
approved for pain management in MS or other pain
producing conditions.
Although it targets oral mucosa, it has recently been suggested
that the drug is partially washed away by saliva and absorbed
in the GI tract.
Patents
1) Granted: Chewing gum
comprising cannabinoids.
2) Granted: Process to extract
and purify delta-9-THC.
Sativex (nabiximols, THC+CBD)
Approved for use in Europe and Canada.
Oromucosal spray approved in multiple jurisdictions in Europe and
Canada (not U.S. currently) for treatment of spasticity associated
with MS.
Competitive Advantage
MedChew™ Rx contains the same constituents
as Sativex, however provides extended dosing,
reducing the need to readminister, which for
Sativex is up to 12 times per day, MedChew™ Rx
does not contain alcohol, which Sativex does,
and will not exacerbate the dry mouth that
is ofter associated by MS pharmacotherapy.
Incannex
Administered too frequently - up to 12 times per day.
Alcohol in formulation exacerbates dry mouth symptoms associated
with MS pharmacotherapy.
Addressable Market
MedChew™ Rx (THC+CBD)
MedChewTM Rx is absorbed in oral mucosa, bypassing first pass
metabolism, increasing bioavailability.
Increased bioavailability may also mean that MedChew™ Rx
is effective at treating pain associated with MS.
US$ 62B* 50%
Associated Total Global Direct
Healthcare Costs in '21
Increase in Global MS
Prevalence 2013 to 2020
MedChewTM Rx provides extended dosing, reducing need
to readminister frequently.
The MedChewTM Rx formulation has been developed and patented
by APIRX.
MedChew™ Rx does not contain any alcohol.
Pre-IND meetings completed with Swiss-Medic (Switzerland)
and CBG-MEG (Netherlands).
Lead Assets
●●●●●●00
* Frost Sullivan Market Report as commissioned by APIRX, Oct. 2021
Next Steps:
Step 1 - Potential fastrack to EMA drug approval with bioequivalent
phase 1 bridging study* to bridge to Sativex CBD/THC oral spray
safety and efficacy data.
Step 2 - Additional late stage (phase 3 or 4) clinical trials to support
extension of label claims to additional indications where THC+CBD
is reported to have a therapeutic benefit.
*a bridging study is a study designed to demonstrate that an investigational product
is sufficiently similar to an approved product and establish a bridge to data, safety and/or
efficacy, that is already accepted by the regulatory authority for the approved drug product
Investor Presentation
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