SiteOne Therapeutics Announces Positive Phase 1 Clinical Data for STC-004, a Novel NaV1.8 Inhibitor in Development for the Non-Opioid Treatment of Pain

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SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Feb 4, 2025--

SiteOne Therapeutics, Inc., a clinical-stage biopharmaceutical company developing selective ion channel modulators for the treatment of pain, cough, and other conditions involving hyperexcitability of the peripheral nervous system, today announced positive phase 1 clinical trial results for STC-004, its lead Na V 1.8 inhibitor for the non-opioid treatment of pain.

"These compelling phase 1 results reinforce the potential of STC-004 as a transformative, non-opioid solution for pain management,” said John Mulcahy, Ph.D., President and CEO of SiteOne Therapeutics. “The data demonstrate target engagement at low, once-daily doses, validating our approach and advancing our mission to provide patients with safer, more effective pain relief. With these results in hand, we are focused on rapidly advancing STC-004 into Phase 2 trials in the second half of this year."

STC-004 is an oral, highly selective Na V 1.8 inhibitor under development for the treatment of acute and chronic peripheral pain. The phase 1 study, STC-004-CS-001, evaluated the safety, tolerability and pharmacokinetics of the candidate in single ascending dose (SAD) and multiple ascending dose (MAD) arms. Pharmacokinetic data showed rapid absorption with a half-life appropriate for once-daily oral dosing. Exposure was proportional and demonstrated low variability across the dose range. STC-004 was well-tolerated at all doses tested.

Pharmacodynamic testing performed during the MAD cohorts using the Cold Pressor Test (CPT) model of experimental pain supported target engagement across the dose range tested. Statistically significant increases in the Pain Tolerance Threshold (PTT) were observed. These findings are consistent with target engagement of the human Na V 1.8 channel at low, once-daily oral doses, demonstrating significant analgesic potential.

About SiteOne Therapeutics

SiteOne Therapeutics is a clinical-stage biopharmaceutical company advancing a novel class of highly selective small molecule inhibitors targeting Na V 1.7, Na V 1.8, and other ion channels to treat pain, cough and other conditions involving hyperexcitability of the peripheral nervous system. Since its inception, SiteOne has been dedicated to the development of safe and effective pain therapeutics without the significant addiction potential and side effects of opioids. The company is also advancing additional novel drug candidates that exhibit precise selectivity for individual ion channel subtypes to treat other sensory hyperexcitability disorders such as chronic cough and chronic ocular surface pain. For more information, visit www.siteonetherapeutics.com.

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KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA

INDUSTRY KEYWORD: SCIENCE BIOTECHNOLOGY RESEARCH PHARMACEUTICAL GENERAL HEALTH HEALTH CLINICAL TRIALS OTHER HEALTH

SOURCE: SiteOne Therapeutics, Inc.

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PUB: 02/04/2025 09:00 AM/DISC: 02/04/2025 09:00 AM

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