Emyria Advances EMD-004 Program Towards Registration
Released
Released
Announcement PDF
ASX Announcement
15/06/2021
Emyria advances EMD-004 program towards registration
Highlights:
●
Emyria has filed additional patents supporting its EMD-004 drug development
program targeting Irritable Bowel Syndrome (IBS)
●
Emyria’s patents were filed after signal analysis of Emyria’s clinical data (Emyria
Data), one of the largest, trials-grade clinical registries for medicinal cannabis, and an
extensive review of the global literature and patent landscape
●
Emyria’s patents cover unique dose strengths and formulations, believed to be most
effective in treating a range of IBS-related symptoms including:
●
CBD-only formulations which could support a Schedule 3, over-the-counter
registration program in Australia and;
●
CBD and THC containing formulations which could support higher Schedule
applications and international registrations including US FDA
●
There are currently no approved drug treatments for IBS which affects around 11% of
the population globally and is a significant unmet need [1]
Emyria Limited (ASX: EMD) (Emyria or the Company), a drug development and clinical
services company, is pleased to announce further intellectual property (IP) has been filed in
support of its EMD-004 drug development program targeting the symptoms of irritable
bowel syndrome (IBS). (See ASX release 03 Dec 2020)
IBS is a group of symptoms that occur together, including repeated pain in your abdomen
and changes in your bowel movements, which may be diarrhea, constipation, or both. With
IBS, you have these symptoms without any visible signs of damage or disease in your
digestive tract which is why the condition can be challenging to diagnose and treat. [2]
IBS affects around 11% of the population globally and is a significant unmet need often
associated with greater levels of anxiety and lower quality of life measures. There are
currently no approved drug treatments for IBS.
The new IP was filed after extensive analysis of Emyria’s proprietary clinical data (Emyria
Data). Emyria Data is deep clinical data collected with consenting patients who obtained
relief from their IBS condition while being treated at Emyria’s wholly-owned, nationwide
clinical subsidiary - Emerald Clinics.
EMD-004 is Emyria’s second drug development program to be launched following analysis of
Emyria Data. A large observational study involving IBS patients is currently underway across
Emerald Clinics.
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Emyria Data is one of the largest and highest quality real-world clinical data sets in the world
covering the long-term safety and efficacy of pharmaceutical-grade cannabinoid-based
medicines prescribed for thousands of patients with unmet needs.
Analysis of Emyria Data has also supported the patents and clinical development strategy of
Emyria’s leading EMD-003 program which is currently progressing towards registration as a
Schedule 3, over-the-counter cannabinoid-based medicine. (See ASX release 07 Apr 2021)
The high quality, validity and utility of Emyria Data was recently demonstrated by a unique
piece of analysis performed with global clinical research organisation, IQVIA (NYSE: IQV). (See
ASX release 07 June 21)
Emyria’s Managing Director, Dr. Michael Winlo says: “A major benefit of Emyria’s high
quality, real-world clinical data is that it allows us to frequently and confidently file
differentiated and strongly developed patents that support and defend our parallel-running
drug development programs.
Just like EMD-003, our first cannabinoid medicine drug development program targeting
psychological distress, EMD-004 is now well defined with patents filed covering our unique
dose response insights for specific patient populations.
Filing IP of this kind is crucial in helping differentiate, and ultimately register,
cannabinoid-based treatments in major markets around the world. This is what large
pharma look for in drug development programs.
We are constantly analysing our proprietary clinical data which was recently validated in a
data linkage project with global clinical research organisation, IQVIA. In addition to further IP,
our ongoing analysis allows us to launch new drug development programs in parallel, each
targeting major, global, unmet needs.”
The company will provide further updates on EMD-003, EMD-004 and future drug
development programs as registration activities and analysis continues.
This announcement has been approved and authorised by the Board of Emyria Limited.
For further information on Emyria:
Dr Michael Winlo
Managing Director
(08) 6559 2800
mwinlo@emyria.com
Lexi O’Halloran
Investor Relations
+ 61 (0) 404 577 076
lexi@janemorganmanagement.com.au
Andrew Williams
Media Relations
+61 (0) 412 614 125
andreww@profilemedia.com.au
REFERENCES
[1] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3921083/
[2]
https://www.niddk.nih.gov/health-information/digestive-diseases/irritable-bowel-syndrome/definition-fa
cts
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About Emyria (www.emyria.com)
Emyria Limited is a data-backed, drug development company. Emyria’s Treatments target
unmet needs and are focused on obtaining approval from major global regulators. Emyria’s
drug development programs are informed by insights generated from extensive analysis of
Emyria Data - deep, ethically-sourced clinical evidence that is gathered with patients across
Emyria’s independent clinical services (Emerald Clinics - www.emeraldclinics.com.au)
Emyria Data provides deep treatment insights and is therefore a source of unique IP,
strategically designed drug development and personalised care programs.
Emyria’s first drug development program, EMD-003 is targeting unmet needs in mental
health. Specifically psychological distress and the symptoms of anxiety, depression and
stress.
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for the Company,
the company’s strategy, future operations, and other statements containing the words “anticipate,”
“believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,”
“would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements.
Actual results may differ materially from those indicated by such forward-looking statements as a
result of various important factors, including: the Company’s ability to successfully develop its product
candidates and timely complete its planned clinical programs and the Company’s ability to obtain
marketing approvals for its product candidates. In addition, the forward-looking statements included
in this press release represents the Company’s views as of the date hereof. The Company anticipates
that subsequent events and developments will cause the Company’s views to change. However, while
the Company may elect to update these forward-looking statements at some point in the future, the
Company specifically disclaims any obligation to do so. These forward-looking statements should not
be relied upon as representing the Company’s views as of any date subsequent to the date hereof.
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