SiteOne Therapeutics Reports Positive Phase 1 Data for Pain Treatment NaV1.8 Inhibitor STC-004

SOUTH SAN FRANCISCO, CA, USA I February 04, 2025 I SiteOne Therapeutics, Inc., a company at the forefront of biopharmaceutical developments, has announced promising results from a phase 1 clinical trial for its leading product, STC-004. This innovative drug is being developed as a non-opioid treatment option for pain management.

The CEO and President of SiteOne Therapeutics, Dr. John Mulcahy, expressed enthusiasm regarding the findings, which underscore the potential of STC-004 to revolutionize pain treatment. He highlighted that the trial data successfully demonstrated the drug's target engagement at low, once-daily doses. This aligns with SiteOne's mission to offer patients safer, more efficient options for pain relief. With these results, the company is now keen on progressing STC-004 into phase 2 trials later this year.

STC-004 is designed as an oral NaV1.8 inhibitor to address both acute and chronic peripheral pain. The phase 1 clinical trial, identified as STC-004-CS-001, was structured to assess the safety, tolerability, and pharmacokinetics of the drug through single ascending dose (SAD) and multiple ascending dose (MAD) evaluations. The pharmacokinetic analysis indicated that the drug is absorbed quickly and maintains a half-life that suits once-daily oral administration. Additionally, the drug exposure was consistent and displayed minimal variability across different doses. Notably, STC-004 was comfortably tolerated across all doses evaluated.

The pharmacodynamic aspects of the trial, particularly during the MAD phase utilizing the Cold Pressor Test (CPT) model, further validated the drug's effectiveness. The test results revealed statistically significant improvements in the Pain Tolerance Threshold (PTT), confirming that STC-004 effectively engages the human NaV1.8 channel at low doses administered once daily. These findings highlight the drug's potential as a significant analgesic.

SiteOne Therapeutics stands as a clinical-stage biopharmaceutical entity that is pioneering a unique class of highly selective ion channel inhibitors. Their focus includes NaV1.7 and NaV1.8 channels, aimed at treating pain, cough, and other disorders related to peripheral nervous system hyperexcitability. From its inception, the company has been committed to developing pain management solutions that mitigate the addiction risks and side effects commonly associated with opioid treatments. In addition to STC-004, SiteOne is advancing other drug candidates that show precise selectivity for specific ion channel subtypes, aiming to tackle other sensory hyperexcitability conditions such as chronic cough and persistent ocular surface pain.