Elysium Therapeutics to Present Phase 1 Proof-of-Concept Results for Novel SMART™ O2P Opioid Technology at PAINWeek 2024

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Jul 23, 2024, 08:30 ET

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.

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