Positive results received for Emyrias MDMA-inspired program
Released
Released
Announcement PDF
ASX Announcement
18 Aug 2022
Emyria receives positive screening results for MDMA-inspired drug
discovery program
Highlights:
●
Emyria and the University of Western Australia (UWA) have received positive screening
results from the third batch of MDMA analogues sent to Eurofins
●
All 19 compounds demonstrate no significant interactions with selected
“anti-targets” (receptors & enzymes known to be involved in unwanted side effects)
●
125 compounds have now been successfully created and screened as part of Emyria’s
unique “New Drug Discovery Program” including 45 new MDMA analogues created
since inception of the collaboration
●
Multiple preclinical programs are underway to evaluate the potential of a select
group of high priority compounds to become registered medicines.
●
These results are guiding further drug synthesis, expanding one of the
world’s largest libraries of novel MDMA-inspired compounds
Emyria Limited (ASX: EMD) (Emyria or the Company), a clinical stage biotech is pleased to
announce positive progress on its novel drug discovery program inspired by MDMA (aka
‘ecstasy’) with partner the University of Western Australia (UWA).
Positive screening results grows MDMA analogue library
All 19 compounds sent from the third batch of compounds successfully passed screening
with Eurofins at the test concentrations. These compounds showed no evidence of
significant interactions with any of the enzymes or cell receptors (“anti-targets”) that can be
associated with unwanted clinical side effects.
Over 100 compounds have now been successfully screened. The positive results continue
to inform the drug design process. Synthesis of additional novel analogues guided by
screening results is ongoing. (See ASX releases 08 Dec 2021 and 22 May 2022).
Preclinical evaluations have commenced on a number of high priority compounds selected
based on these initial screening results. (See ASX releases 09 May 2022 and 04 Aug 2022)
Approval has been received from the US Drug Enforcement Agency (DEA) to transport 5
high priority MDMA-analogues to the US, allowing for engagement with leading US-based
research bodies and potential partners. (See ASX release 04 Aug 2022)
Emyria ASX Announcement | 18 August 2022
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Emyria has identified three potential therapeutic areas for its MDMA-inspired drug
discovery program:
1.
treatments for major mental health disorders where more potent and
shorter-acting MDMA-like treatments, when given alongside therapy, may offer
advantages over standard MDMA in drug-assisted therapy
2.
treatments for neurological disorders where selective neurological receptor
effects are desired and;
3.
treatments for non-neurological disorders where selective activity at peripheral
(non-brain) targets are of interest
Emyria’s Managing Director, Dr. Michael Winlo said: “Emyria’s drug discovery and
screening program with partner the University of Western Australia continues to make
exciting forward progress.
These latest positive screening results will help guide the creation of the next batch of
novel MDMA-inspired compounds for our drug discovery portfolio.
These results will also help inform which leads to advance to preclinical screening in our
three, high-priority areas; next generation psychedelic-assisted therapies as well as
potential treatments for unmet neurological and non-neurological conditions.”
This announcement has been approved and authorised for release by the Board of Emyria
Limited.
For further information:
Dr. Michael Winlo
Managing Director
+61 (0) 8 6559 2800
mwinlo@emyria.com
Lexi O’Halloran
Investor Relations
+61 (0) 404 577 076
investors@emyria.com
Andrew Williams
Media Relations
+61 (0) 416 583 672
awilliams@emyria.com
EMYRIA’S INTERACTIVE INVESTOR HUB
https://investorhub.emyria.com
Our investor hub is a place to interact with our announcements and updates. You can ask
questions and add comments, which our team can respond to where possible.
Emyria ASX Announcement | 18 August 2022
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The MDMA-inspired analogue library
MDMA (‘ecstasy’) is showing promise as an adjunct to psychotherapy for the treatment
of major unmet mental health needs (i.e “psychedelic-assisted therapy”).
Emyria aims to develop new compounds inspired by MDMA. Like MDMA, its analogues
are small, orally absorbed and central-nervous penetrating molecules that interact with a
variety of targets in the brain and peripheral tissues and therefore hold promise as new
treatments for a range of neurological and non-neurological disorders.
Emyria has created and screened over 125 MDMA-inspired analogues led by Professor
Matt Piggott in partnership with the University of Western Australia. Prof. Piggott is an
expert in medicinal chemistry and an international leader in modifying MDMA to create
novel analogues with therapeutic potential. Emyria formed a partnership with the
University of Western Australia to expand and develop an exclusive library of novel,
MDMA-inspired compounds (“MDMA analogues”) creating a unique drug-discovery
pipeline. (See ASX announcement 05 Aug 2021)
The analogues are unique chemical entities that are structurally similar to
3,4-Methylenedioxymethamphetamine (‘MDMA’, ‘ecstasy’), but designed to engage
different neurological targets, and therefore, elicit potentially unique clinical and
neuro-cognitive effects.
MDMA-analogues have also shown promise as treatments for other neurological
disorders, such as Parkinson’s Disease. In these indications, it may be desirable to limit or
remove the euphoric and stimulant effects of MDMA.
Therefore, for the treatment of certain psychiatric and neurological disorders, there is an
interest in developing MDMA-like compounds that are more selective for specific
neurological receptors. More selective drug candidates have the potential to become
treatments for large patient populations with reduced cost and increased efficacy.
Emyria ASX Announcement | 18 August 2022
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UPCOMING DRUG DEVELOPMENT MILESTONES
CLINICAL PROGRAMS
Repurposing “ultra-pure” cannabinoids
EMD-RX5
“direct-to-consumer”
program
EMD-RX7
“prescription medicine”
program
PRE-CLINICAL PROGRAM
MDMA-inspired
drug development
Formulation
optimisation
Formulation
optimisation
Screening results for first
85 compounds
Phase 1
Phase 1
First patent family filed
Ethics submitted
for Phase 3
Pre-IND (FDA)
Batch 3 sent
Phase 3
commencement
Pivotal trials
Batch 3 screening results
Regulatory
submission
Create and screen
additional batches
Commercial
strategy Australia
Metabolic studies
Commercial
strategy Europe
Preclinical assays
(multiple animal models)
Commercial
strategy USA
Human cell line assays
Lead selection
Phase 1 trials
Emyria ASX Announcement | 18 August 2022
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ABOUT EMYRIA | emyria.com
Emyria Limited is a clinical stage biotech focussed on accelerating treatment
development and improving patient care by:
1.
2.
3.
Collecting and analysing Real-World Data (RWD): Emyria gathers
ethically-sourced clinical evidence with patients across Emyria’s independent
clinical services (emeraldclinics.com.au). Emyria’s proprietary RWD provides deep
treatment and drug development insights.
Repurposing promising treatments: Emyria uses its RWD to improve the
formulations of, and find new indications for, select medications. Emyria’s first
repurposed and proprietary drug products (EMD-RX5 and EMD-RX7) incorporate
Ultra-Pure cannabinoids and are targeting global registration opportunities as
over-the-counter and prescription-only medicines.
Developing analogues of promising new compounds: Emyria collaborates with
leading institutions to develop new chemical entities inspired by promising
molecules. Emyria’s first new chemical entity program is focussed on generating
novel MDMA-inspired analogues with the potential to become registered therapies
for a range of major unmet needs.
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.
Emyria ASX Announcement | 18 August 2022
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