Ensysce Biosciences Receives Notice of Award for Year Three of Multi-Year NIDA Grant for the Clinical Development of its Next...
08 Julho 2021 - 9:00AM
Ensysce Biosciences, Inc. (NASDAQ: ENSC) (“Ensysce” or “the
Company”), a clinical stage biotech company with proprietary
technology platforms to reduce the economic and social burden of
prescription drug abuse and overdose, today announced receipt of
the 3rd year award of a multi-year grant from the National
Institute on Drug Abuse (NIDA). This award will provide $2.8
million to initiate a Phase 1 study of the first
MPAR™ overdose protection product in the U.S., PF614-MPAR.
This brings the total support of NIDA to $8.0 million. An
additional $2.8 million award for year four is pending.
“We are honored to receive the UH3 award titled ‘PF614 MPAR
Abuse Deterrent opioid prodrug with overdose protection:
Pre-Clinical Development and Phase 1 Clinical Trial’ from the
National Institute on Drug Abuse, which provides us with additional
resources to continue our work to bring PF614-MPAR™ into clinical
development,” said Dr. Lynn Kirkpatrick, Chief Executive Officer of
Ensysce Biosciences. “Importantly, our next-generation opioid
platform is highly differentiated from currently marketed opioid
products and designed to significantly reduce abuse potential and
overdose protection. We remain focused on our commitment to stem
the prescription drug abuse epidemic and look forward to bringing
our unique pipeline of products to the industry, which will
ultimately provide safer options for both prescribers and
patients.”
PF614-MPAR™ is designed as an extended-release oxycodone prodrug
with both trypsin-activated abuse protection (TAAP) and overdose
protection through multi-pill abuse resistance (MPAR™) technology.
TAAP chemical modification inactivates the active ingredient in
PF614 to provide abuse deterrence, and the combination with the
trypsin inhibitor, nafamostat, in MPAR™ provides the additional
layer of overdose protection. The MPAR™ overdose protection has
been demonstrated in animals and the Phase 1 study with PF614 is
being conducted to further validate the MPAR™ overdose protection
technology. The Phase 1 study trial, “A Single Dose Study to
Evaluate the Pharmacokinetics of oxycodone and PF614, when PF614
Solution is Co-Administered with Nafamostat, as an Immediate
Release Solution and/or Extended Release (ER) Capsule Formulations
in Healthy Subjects” is being conducted by Dr. Maricer Escalon MD,
MS, MBA at Quotient Sciences.
“This award further confirms Ensysce’s important TAAP and MPAR™
technology, which has been recognized by NIH, NIDA and the Federal
Government,” said Dr. William Schmidt, Chief Medical Officer of
Ensysce. “We remain committed to addressing the significant unmet
needs in the marketplace, and look forward to advancing our
pipeline of opioid TAAP and MPAR™ products to combat the opioid
crisis.”
About Ensysce Biosciences: Ensysce Biosciences,
San Diego, CA is a clinical-stage biotech company using its
proprietary technology platforms to develop safer prescription
drugs. Leveraging its Trypsin Activated Abuse Protection (TAAP) and
Multi-Pill Abuse Resistance (MPAR™) platforms, the Company is in
the process of developing a new class of powerful, tamper-proof
opioids that prevent both drug abuse and overdoses. Ensysce’s
products are anticipated to provide safer options to treat severe
pain and assist in preventing deaths caused by opioid abuse,
reducing the human and economic cost. The platforms are covered by
an extensive worldwide intellectual property portfolio for a wide
array of prescription drug compositions. For more information,
please visit www.ensysce.com.
Forward-Looking Statements
Statements contained in this press release that are not purely
historical may be deemed to be forward-looking statements for the
purposes of the safe harbor provisions under The Private Securities
Litigation Reform Act of 1995 and other federal securities laws.
Without limiting the foregoing, the use of words such as “may,”
“intends,” “can,” “might,” “will,” “expect,” “plan,” and other
similar expressions are intended to identify forward-looking
statements. The product candidates discussed are in clinic and not
approved and there can be no assurance that the clinical programs
will be successful in demonstrating safety and/or efficacy, that
Ensysce will not encounter problems or delays in clinical
development, or that any product candidate will ever receive
regulatory approval or be successfully commercialized. All
forward-looking statements are based on estimates and assumptions
by Ensysce’s management that, although Ensysce believes to be
reasonable, are inherently uncertain. All forward-looking
statements are subject to risks and uncertainties that may cause
actual results to differ materially from those that Ensysce
expected. In addition, Ensysce’s business is subject to additional
risks and uncertainties, including among others, the initiation and
conduct of preclinical studies and clinical trials; the timing and
availability of data from preclinical studies and clinical trials;
expectations for regulatory submissions and approvals; potential
safety concerns related to, or efficacy of, Ensysce’s product
candidates; the availability or commercial potential of product
candidates; the ability of Ensysce to fund its continued
operations, including its planned clinical trials; and Ensysce’s
and its partners’ ability to perform under their license,
collaboration and manufacturing arrangements. These statements are
also subject to a number of material risks and uncertainties that
are described in Ensysce’s definitive proxy statement/prospectus
relating to the recently completed business combination with
Leisure Acquisition Corp., which is available, free of charge, at
the SEC’s website at www.sec.gov. Any forward-looking statement
speaks only as of the date on which it was made. Ensysce undertakes
no obligation to publicly update or revise any forward-looking
statement, whether as a result of new information, future events or
otherwise, except as required under applicable law.
Ensysce Biosciences Company ContactLynn
Kirkpatrick, Ph.D.Chief Executive Officer (858) 263-4196
Ensysce Biosciences Investor Relations
Contact:Gateway Investor RelationsAlex Thompson | Matt
Glover(949) 574-3860Ensysce@gatewayir.com
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