SiteOne Therapeutics announced positive Phase 1 clinical trial results for STC-004, its lead NaV1.8 inhibitor for non-opioid pain treatment. The trial demonstrated target engagement at low, once-daily doses, suggesting the drug’s potential as a safer alternative to opioids. The positive results pave the way for Phase 2 trials later this year.
The success of STC-004’s Phase 1 trial is a significant advancement in the pursuit of effective non-opioid pain medications. The opioid crisis continues to devastate communities, and the need for alternative pain management solutions is critical. STC-004’s potential to provide pain relief without the addictive properties of opioids could significantly improve patient outcomes and address a major public health concern. The demonstration of target engagement at low doses further strengthens the drug’s potential as a viable alternative by minimizing side effects.
The Phase 1 study, STC-004-CS-001, assessed the safety, tolerability, and pharmacokinetics of STC-004 in single and multiple ascending dose arms. Data revealed rapid absorption, a half-life suitable for once-daily dosing, proportional exposure, and low variability across the dose range. The drug was well-tolerated at all tested doses. Pharmacodynamic tests using the Cold Pressor Test showed statistically significant increases in the Pain Tolerance Threshold, confirming target engagement of the NaV1.8 channel at low doses and indicating significant analgesic potential.
The positive Phase 1 results position SiteOne Therapeutics to move STC-004 rapidly into Phase 2 trials. This progress brings the company closer to delivering a much-needed non-opioid pain treatment option to patients and potentially reshaping the landscape of pain management. The upcoming Phase 2 trials will be crucial for further validating the drug’s efficacy and safety profile, setting the stage for potential future regulatory approval and market entry.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
