Elysium Therapeutics Unveils Phase 1 Results for SMART™ O2P Opioid Tech at PAINWeek 2024

Elysium Therapeutics, a burgeoning biopharmaceutical firm aiming to set new safety benchmarks in the opioid sector, recently announced significant findings from its Phase 1 human proof-of-concept study. This study evaluates their innovative Oral Overdose Protected (O2P™) hydrocodone prodrug, designed for moderate-to-severe acute pain management. The results will be presented at PAINWeek 2024, scheduled from September 3-6 in Las Vegas.

The study, titled "SMART™ Opioids with Unprecedented Protection Against Abuse and Oral Overdose – Human Proof-of-Concept," focuses on the safety, tolerability, and pharmacokinetics of O2P Hydrocodone in comparison to hydrocodone bitartrate (HCBT). The successful Phase 1 results highlight a promising approach that offers effective pain relief while mitigating significant risks such as abuse, diversion, and fatal overdose.

SMART™ opioid prodrugs utilize Elysium's proprietary O2P technology to tackle both non-oral and oral abuse issues. This technology ensures the safe delivery of FDA-approved opioid agonists, crucial for acute pain treatment. One major achievement of the Phase 1 study was the substantial reduction in prescribed doses. This finding is pivotal as it helps diminish misuse, abuse, and diversion and limits the occurrence of euphoric experiences that often lead to addiction.

Tom Jenkins, Ph.D., Co-Founder and Chief Scientific Officer of Elysium Therapeutics, emphasized the importance of their findings. He noted that O2P Hydrocodone maintains sustained plasma exposure, consistent with a once-daily dosing regimen. This can significantly lower the number of prescribed tablets compared to existing hydrocodone prescriptions. Furthermore, the technology is engineered to reduce hydrocodone exposure when high doses are ingested, thus curbing euphoric experiences.

Greg Sturmer, Co-Founder and CEO of Elysium Therapeutics, highlighted the company's mission to redefine safety standards in the opioid industry. He expressed optimism that their O2P Hydrocodone technology could dramatically lower the risk of fatal overdoses while offering unparalleled acute pain management.

The O2P-001 study was a Phase 1, human proof-of-concept, randomized, open-label, two-part study that assessed the safety and pharmacokinetics of O2P Hydrocodone in healthy adult subjects. The main objectives were to evaluate the safety, tolerability, and pharmacokinetics of O2P Hydrocodone compared to a hydrocodone comparator using single oral doses in adults with naltrexone blockade. The study also aimed to demonstrate reduced dose-proportional plasma exposures of O2P Hydrocodone to offer oral overdose protection compared to escalated doses of hydrocodone. A total of 93 subjects participated in the study.

Elysium Therapeutics is dedicated to reducing the risks associated with opioids and overdose rescue agents. Their lead product candidate, O2P Hydrocodone, is being developed for moderate-to-severe acute pain. The company is also working on SOOPR™ (Synthetic Opioid Overdose Prevention and Reversal), a long-acting opioid antagonist specifically designed to counteract overdoses from synthetic opioids like fentanyl. The high number of annual overdose deaths underscores the urgent need for more effective solutions, highlighting the limitations of current rescue agents such as naloxone and nalmefene.

In summary, Elysium Therapeutics presents a groundbreaking approach to opioid safety with its O2P technology, offering a potential solution to the opioid crisis by providing effective pain relief while minimizing the risks of abuse and overdose.