DemeRx Doses First Subject in Phase 1/2a Study of DMX-1002 (Ibogaine) in Opioid Use Disorder
September 21 2021 - 8:00AM
DemeRx IB, Inc. ("DemeRx"), an atai Life Sciences (Nasdaq: ATAI)
("atai") platform company focused on developing ibogaine for the
treatment of opioid use disorder (OUD), today announced that the
first subjects have been dosed in a Phase 1/2a clinical trial of
ibogaine HCl (DMX-1002). The trial has commenced enrollment and
dosing of recreational drug users and healthy volunteers in the
Phase 1 segment of the study at the Manchester clinical unit of MAC
Clinical Research (MAC) in the UK, one of Europe’s largest clinical
development organizations.
DMX-1002 is an oral formulation of ibogaine, a naturally
occurring psychedelic product isolated from a West African shrub.
In previously published non-controlled studies, ibogaine has
demonstrated rapid and sustained efficacy in treating OUD and has
the potential to be a disease modifying treatment for this
vulnerable patient population seeking to end their intractable
cycle of drug dependence.
The Phase 1/2a trial is designed to assess safety, tolerability,
pharmacokinetics, and efficacy, and the results will inform future
studies in patients with opioid use disorder. We expect to obtain
safety data from the phase 1 segment of this trial in early
2022.
“By launching the Phase1/2a trial, we look forward to bringing
important data from carefully designed, controlled studies to the
existing literature on ibogaine, a compound with substantial
history,” said Dr. Deborah Mash, CEO and President of DemeRx. “We
are hopeful that this early trial can begin to establish a safe and
efficacious profile for Ibogaine, so that we can potentially offer
a new option for patients seeking to break free from OUD who have
far too few options.”
“The opioid crisis has ravaged the U.S. for over 20 years with
little sign of letting up. The COVID-19 pandemic revealed the
tragic vulnerability of people addicted to drugs as the CDC tallied
93,000 drug overdose deaths in 2020, a 30% increase, 70,000 of
which involved opioids,” added Srinivas Rao, Chief Scientific
Officer and Co-founder of atai Life Sciences. “Launching our Phase
1/2a trial of ibogaine with assent of regulators, we believe is a
major step towards reversing the trend of the opioid crisis.”
“We strive for bold innovation to address the global crisis of
mental health,” said Florian Brand, Chief Executive Officer and
Co-founder of atai Life Sciences. “By launching this Phase 1/2a
trial, we are grateful for the work of our dedicated teams at
DemeRx and atai who are committed to this ethos, striving to bring
transformative treatments through rigorous testing.”
About DemeRx, Inc. & DMX-1002
DemeRx, Inc. is a Miami-based clinical stage pharmaceutical
company focused on developing ibogaine and noribogaine for the
treatment of OUD. DemeRx’s mission is to advance the development of
potential treatments for OUD in order to prevent patient suffering,
provide better treatment retention, and decrease illegal opioid
use.
DemeRx is developing DMX-1002 for the treatment of OUD. DMX-1002
is a GMP drug product manufactured for human use.
About atai Life Sciences
atai is a clinical-stage biopharmaceutical company aiming to
transform the treatment of mental health disorders. atai was
founded in 2018 as a response to the significant unmet need and
lack of innovation in the mental health treatment landscape. atai
is dedicated to acquiring, incubating and efficiently developing
innovative therapeutics to treat depression, anxiety, addiction,
and other mental health disorders. atai's business model combines
funding, technology, scientific and regulatory expertise with a
focus on psychedelic therapy and other drugs with differentiated
safety profiles and therapeutic potential. By pooling resources and
best practices, atai aims to responsibly accelerate the development
of new medicines across its companies, seeking to effectively treat
and ultimately heal mental health disorders. atai's mission is to
bridge the gap between what the mental healthcare system currently
provides and what patients need. atai has offices in New York,
London, and Berlin. For more information, please visit
www.atai.life.
Forward-Looking StatementsThis press release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. Any express or
implied statements contained in this press release that are not
statements of historical fact may be deemed to be forward-looking
statements, including without limitation statements regarding the
initiation of the Phase 1/2a clinical trial of ibogaine HCl and
future activities thereunder, the potential of DMX-1002, and
similar statements of a future or forward-looking nature.
Forward-looking statements are neither promises nor guarantees, but
involve known and unknown risks and uncertainties that could cause
actual results to differ materially from those projected,
including, without limitation, the important factors discussed
under the caption “Risk Factors” in atai's prospectus pursuant to
Rule 424(b) filed with the U.S. Securities and Exchange Commission
(“SEC”) on June 21, 2021, as such factors may be updated from time
to time in atai's other filings with the SEC. Any forward-looking
statements contained in this press release speak only as of the
date hereof and accordingly undue reliance should not be placed on
such statements. atai disclaims any obligation or undertaking to
update or revise any forward-looking statements contained in this
press release, whether as a result of new information, future
events or otherwise, other than to the extent required by
applicable law.
Contact Information
For atai:
Investor Contact:Greg Weaveratai – Chief Financial OfficerEmail:
greg.weaver@atai.life
Media Contact:Anne DonohoeKCSA Strategic CommunicationsPhone: +1
(212) 896-1265Email: atai@KCSA.com
For DemeRx:
Company Contacts:
Deborah C Mash PhDCEO & Founder, DemeRx Inc.Phone:
+1(305)753-2175Email: dmash@demerx.com
Matthias Luz MDExecutive Vice President & Chief Medical
OfficerEmail: mluz@demerx.com
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