Phase 1 results
demonstrated effective acute pain relief while
simultaneously mitigating the major risks of existing
opioids by protecting against abuse and fatal
overdose
LYONS,
Colo., July 23, 2024 /PRNewswire/ -- Elysium
Therapeutics, an emerging biopharmaceutical company establishing
new standards for safety in the opioid industry by developing
SMART™ (Safer Medicines Alleviate Risks and Trauma) products,
first- and best-in-class medicines to address the limitations and
dangers associated with opioids and overdose rescue agents, today
announced that results from a Phase 1, human-proof-of-concept study
investigating the company's proprietary Oral Overdose Protected
(O2P™) hydrocodone prodrug for the treatment of moderate-to-severe
acute pain will be the subject of a poster presentation at PAINWeek
2024 being held September 3-6 in
Las Vegas.
Poster Information:
Title: SMART™ Opioids with Unprecedented Protection
Against Abuse and Oral Overdose – Human Proof-of-Concept
Authors: T. Jenkins, Ph.D., Lynn R. Webster, M.D., Leela Vrishabhendra, M.D., A. Greg Sturmer
"Elysium's mission is to establish a new standard for opioid
safety in the pharmaceutical industry, and we look forward to
presenting these compelling proof-of-concept data involving our O2P
hydrocodone technology, which was shown to be well-tolerated and
able to deliver therapeutically relevant hydrocodone doses while
safeguarding against abuse and fatal overdose," said Tom Jenkins, Ph.D., Co-Founder and CSO of
Elysium Therapeutics. "Our colleagues at PAINWeek recognize the
importance of addressing the opioid epidemic as well as the
important role of opioids in treating moderate-to-severe acute
pain. We look forward to discussing these results and our plans for
progressing O2P hydrocodone to the next phase of clinical trials
following discussions with the FDA."
About O2P™ Hydrocodone
Elysium's lead product candidate – oral-overdose protected
(O2P) hydrocodone – is a hydrocodone prodrug being developed for
the treatment of moderate-to-severe acute pain. Elysium leverages
its proprietary bifunctional prodrug technology, containing a
trypsin-activated opioid delivery subunit that efficiently releases
therapeutic levels of hydrocodone when exposed to the digestive
enzyme trypsin in the lumen of the small intestine, and a trypsin
inhibitor subunit that progressively inhibits trypsin, attenuating
the release of hydrocodone when supratherapeutic doses are
ingested.
About the Phase 1 O2P-001 Study
O2P-001 was a Phase 1, human proof-of-concept, randomized,
open-label, two-part study designed to evaluate the safety and
pharmacokinetics of O2P hydrocodone in healthy adult subjects. The
key objectives of the study were to (i) evaluate the safety,
tolerability, and pharmacokinetics of O2P hydrocodone relative to a
hydrocodone comparator following single oral doses in healthy adult
subjects with naltrexone blockade; and (ii) demonstrate reduced
dose-proportional plasma exposures of hydrocodone (i.e., oral
overdose protection) of O2P hydrocodone relative to an escalated
comparator dose of hydrocodone. A total of 93 subjects were
enrolled in the study.
About Elysium Therapeutics
Elysium is an emerging biopharmaceutical company that is
establishing new standards of safety in the opioid industry by
developing SMART™ (Safer Medicines Alleviate Risks and Trauma)
products, first- and best-in-class medicines that address the
limitations and dangers associated with opioids and overdose rescue
agents to reduce suffering from opioid-use disorder, opioid
overdose, and acute pain. Elysium's lead SMART opioid product
candidate – oral-overdose protected (O2P™) hydrocodone – is being
developed for the treatment of moderate-to-severe acute pain.
Elysium is also developing its SMART rescue medicine, SOOPR™
(Synthetic Opioid Overdose Prevention and Reversal), a long-acting
opioid antagonist specifically designed to address oral synthetic
opioid, including fentanyl, overdose. Tens of thousands of
unnecessary overdose deaths each year exemplifies the critical
shortcomings of currently available rescue agents, including
naloxone and nalmefene. For more information, please visit
https://www.elysiumrx.com.
Contact
Tiberend Strategic Advisors, Inc.
Investors
|
Media
|
David Irish
|
Casey
McDonald
|
(231) 632-0002
|
(646)
577-8520
|
dirish@tiberend.com
|
cmcdonald@tiberend.com
|
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SOURCE Elysium Therapeutics