SiteOne Therapeutics Announces Initiation of Phase 1 Clinical Trial for its Non-Opioid Analgesic for Acute Pain

SOUTH SAN FRANCISCO, Calif., April 20, 2021 /PRNewswire/ -- SiteOne Therapeutics, Inc., a clinical-stage biopharmaceutical company developing new treatments to address conditions involving hypersensitivity of the nervous system, today announced that dosing has commenced in the company's Phase 1, dose-escalation study of ST-2427, a highly selective inhibitor of NaV1.7 for the management of moderate-to-severe pain.

"The initiation of this study represents a significant milestone for the company as it is our first drug candidate to enter the clinic," stated John Mulcahy, Ph.D., chief executive officer of SiteOne. "There is an urgent, unmet need to develop effective non-opioid therapies for pain. Our lead compound, ST-2427, addresses that need by targeting the peripheral nerve fibers that conduct pain signals without the potential for CNS side effects, addiction and abuse liability of opioid medications."

ST-2427 blocks sodium ion channel 1.7 (NaV1.7). NaV1.7 is a subtype of sodium channel that is highly expressed in peripheral nerve fibers, responsible for pain signal transmission, and is validated as a target for pain treatment by human genetics. Individuals lacking this protein are unable to experience pain. By selectively targeting NaV1.7, ST-2427 aims to stop the electrical signals responsible for pain before they reach the central nervous system.

"SiteOne has discovered exquisitely selective modulators of multiple sodium channel subtypes, and we are now advancing development candidates for a number of indications, starting off by addressing acute pain," said Debra Odink, Ph.D., SiteOne's chief development officer. "We look forward to working with the medical community to bring the promise of this new approach to patients and anticipate initial data will drive our future development plans."

The phase 1 study is a randomized, double-blind, placebo-controlled study in healthy adults to evaluate the safety, tolerability, and pharmacokinetics of ST-2427. The study is enrolling subjects at AltaSciences in Overland Park, Kansas. Subjects in each group will be randomized to receive a single dose of ST-2427 or placebo.

Additionally, SiteOne recently announced the expansion its technology platform and clinical development activities to address hypersensitivity disorders more broadly in both the peripheral and central nervous systems. These disorders include chronic cough, neuropathic pain, ocular discomfort, and pruritus.

About the ST-2427 Phase 1 Study
The phase 1, randomized, double-blind, placebo-controlled study in healthy adult males and females will evaluate the safety, tolerability, and pharmacokinetics (PK) of ST-2427. The trial will include careful assessments of treatment effects on vital signs including cardiac and respiratory function and body temperature over a range of doses of ST-2427. SiteOne Therapeutics, Inc. plans to use the safety, tolerability, and PK findings from this study to inform the doses and study design for phase 2 clinical studies in subjects with acute pain. Please refer to clinicaltrials.gov NCT04475198 for additional clinical trial information.

About ST-2427
ST-2427 is an experimental intravenous, non-opioid analgesic for the management of moderate-to-serve severe pain. ST-2427 blocks sodium ion channel 1.7 (NaV1.7).  NaV1.7 is a type of sodium channel that is highly expressed in peripheral nerve fibers that play a critical role in the generation and conduction of pain signals. As ST-2427 does not enter the brain, it is not expected to cause the central nervous system adverse effects (e.g. sedation, nausea, dependence and addition) that plague existing pain therapeutics such as the opioids. The development of ST-2427 was supported by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH) under Award Number UG3DA049599. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

About SiteOne Therapeutics
SiteOne Therapeutics is a clinical-stage biopharmaceutical company advancing novel therapeutics to treat hypersensitivity disorders. 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 sodium channel subtypes to treat other hypersensitivity disorders. SiteOne's therapeutic candidates are highly selective sodium ion channel modulators. For more information, visit www.siteonetherapeutics.com

Media Contacts:
David Schull
Russo Partners, LLC
[email protected]
858-717-2310

Evan Wicker, Ph.D.
Russo Partners, LLC
[email protected]
212-845-4235

SOURCE SiteOne Therapeutics

Related Links

http://www.siteonetherapeutics.com

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