Emyria accepted into National Institutes of Health Program
Released
Released
Announcement PDF
ASX Announcement
28 Nov 2022
Emyria accepted into National Institutes of Health (NIH) Program
HIGHLIGHTS
Emyria has been accepted into the NIH HEAL Initiative® National Institute of Neurological
Disorders and Stroke (NINDS) Preclinical Screening Platform for Pain (PSPP) program.
NINDS is part of the U.S. National Institutes of Health (NIH), and the leading funder of
neurological research in the USA
PSPP will evaluate Emyria’s proprietary formulations of Ultra-Pure cannabinoids for
suitability as treatments for pain
Emyria to focus its EMD-RX7 cannabinoid program on US-FDA registration pathways
Emyria Limited (ASX: EMD) (Emyria or the Company), a clinical stage biotech, is pleased to
announce its acceptance into the Preclinical Screening Platform for Pain Program.
Emyria’s Managing Director, Dr. Michael Winlo, said: “We’re delighted to be accepted
into this prestigious program to comprehensively evaluate the suitability of our unique,
pharmaceutical-grade formulations to address major unmet needs in pain.
Our compelling Real World Data [1] has demonstrated that cannabinoids may be useful
amongst sufferers of chronic, non-cancer pain and we saw a need to develop reliable,
Ultra-Pure dose forms, suitable for registration with major regulators."
The Helping to End Addiction Long-term Initiative, or NIH HEAL Initiative, is an aggressive,
trans-agency effort to speed scientific solutions to stem the national opioid public health
crisis. Launched in April 2018, the initiative is focused on improving prevention and
treatment strategies for opioid misuse and addiction, and enhancing pain management.
For more information, visit: https://heal.nih.gov.
The PSPP program, part of the NIH HEAL Initiative, evaluates non-opioid assets in a battery
of established preclinical models. The PSPP program accepts small molecules, biologics,
devices, or natural products for evaluation, from researchers in academia and industry
worldwide. Visit : https://heal.nih.gov/research/preclinical-translational/screening-platform
- This release has been approved by the Board of Emyria. 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
Emyria ASX Announcement | 28 Nov 2022
Andrew Williams
Media Relations
+61 (0) 416 583 672
awilliams@emyria.com
Sufian Ahmad
Corporate Advisor
+61 (0) 412 316 162
info@62capital.com.au
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EMYRIA’S CARE MODEL REDUCING OPIOID USE BY 30%
BEFORE CARE AT EMYRIA
[2]
CARE AT EMYRIA
Significant (>30%)
reduction in
opioid use
Average oral morphine equivalent
daily dose (oMEDD) trend
(Pre vs Post Emyria) for a cohort of
high opioid users and >6 months
cannabinoid usage
Patients with 6+ months of
cannabinoid usage
Months since first Emyria visit
The chart shows the oral morphine equivalent daily dose (“oMEDD”) for a cohort of
220 patients presenting at Emyria’s Emerald Clinics with a “HIGH” opioid
consumption rating defined as a daily requirement above 160mg..
oMEDD scores were derived by examining linked community pharmacy
dispensing data from NostraData/IQVIA in the 12 months prior and 12 months after
starting care at Emerald Clinics.
The analysis reveals that these patients had a stable oMEDD scores in the 12
months prior to treatment but experienced a significant average reduction of 30%
in their daily oMEDD scores.
References:
[1] Vickery AW, Roth S, Ernenwein T, Kennedy J, Washer P (2022) A large Australian longitudinal
cohort registry demonstrates sustained safety and efficacy of oral medicinal cannabis for at least
two years. PLOS ONE 17(11): e0272241. https://doi.org/10.1371/journal.pone.0272241
[2] See ASX release 07 Jun 2021
Emyria ASX Announcement | 28 Nov 2022
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UPCOMING DRUG DEVELOPMENT MILESTONES
DRUG DEVELOPMENT
NEW DRUG DISCOVERY
CLINICAL PROGRAMS
Ultra-Pure cannabinoid delivery platform
PRE-CLINICAL PROGRAM
MDMA-like analogues
EMD-RX5 “direct-to-consumer”
EMD-RX7 “prescription medicine”
MDMA-like drug development
Formulation optimisation
Formulation optimisation
Continuous creation & screening
Phase 1 study
Phase 1
First patent family filed
Ethics approved for Phase 3
Pre-IND (FDA)
US-focused preclinical program
Phase 3 commencement
Pivotal trials
Metabolic studies
Regulatory submission
Preclinical assays (multiple animal models)
Commercial strategy Australia
Human cell line assays
Commercial strategy Europe
Commercial strategy USA
Advanced assay development
Lead selection
Phase 1 trials
ABOUT EMYRIA | emyria.com
Global commercial strategy
Emyria Limited is a clinical drug development and care delivery company focused on accelerating
drug development and improving patient outcomes in neuroscience and mental health via:
●
Drug Development: Emyria has developed an Ultra-Pure cannabinoid platform that can
support the registration of multiple proprietary dose forms. Emyria’s first dose form,
EMD-RX5 is in Phase 3 trials
●
New Drug Discovery: Inspired by MDMA, Emyria is developing one of the world’s largest
libraries of MDMA-like compounds with partner, the University of Western Australia.
●
Proprietary Real-World Data (RWD): Emyria gathers ethically-sourced data with patients
cared for at Emyria’s own specialist clinical service (Emerald Clinics).
Emyria RWD can help support drug development and care model improvement.
EMYRIA’S
INTERACTIVE
INVESTOR
HUB
Investorhub.emyria.com Interact with Emyria’s announcements and updates by
asking questions and comments, which our team can respond to where possible.
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 | 28 Nov 2022
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