Altasciences and SiteOne Start Phase I Study of Non-Opioid Analgesic for Acute Pain
The award-winning Contract Research Organisation (CRO) Altasciences will initiate a Phase I Study in healthy normal subjects for ST-2427, a non-opioid analgesic for acute pain, developed by clinical-stage biopharmaceutical company SiteOne Therapeutics.
Altasciences announced it is thrilled to help SiteOne Therapeutics with a Phase I, randomized, double-blind, placebo-controlled trial in healthy people to assess ST-2427’s safety, tolerability, and pharmacokinetics.
Phase I study to examines safety, tolerability and pharmacokinetics of non-opioid analgesic drug candidate
ST-2427 is a highly selective inhibitor of NaV1.7 used to treat moderate to severe pain. By targeting NaV1.7 selectively, ST-2427 tries to block the electrical impulses transmitted to the central nervous system, triggering pain.
John Mulcahy, Ph.D., Chief Executive Officer of SiteOne said in a statement:
“The initiation of this study represents a significant milestone for the company as it is our first drug candidate to enter the clinic. 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.”
Amy Denvir, General Manager of Altasciences’ Kansas City clinical site, says:
“We are proud to partner with SiteOne Therapeutics and help move this important therapeutic into clinical trials. Helping bring to market a new approach that may provide a non-opioid option to treat moderate- to-severe pain is an exciting prospect, and we look forward to delivering this ground-breaking research.”
Headquartered in San Francisco, California, SiteOne Therapeutics is developing new treatments to address conditions involving hypersensitivity of the nervous system. The company’s therapeutic candidates are highly selective inhibitors of sodium ion channel isoforms Nav1.7 and Nav1.8.
By delivering excellent, full-service early development solutions, Altasciences has created and implemented hundreds of first-in-human studies. Through combining clinical pharmacology services, biomarker capabilities, PK/PD analytic knowledge, and program management expertise, the organization cuts down on the time it takes to make key go/no-go judgments.
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 – non-opioid analgesic
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.
Altasciences is an integrated drug development company that provides a proven, flexible-efficient approach to preclinical and clinical pharmacology trials, as well as formulation, manufacturing, and analytical services to pharmaceutical and biotechnology organizations. Altasciences has been working with sponsors for over 25 years to promote educated, quicker, and much more thorough early drug development decisions.
Preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management are all included in Altasciences’ integrated, full-service solutions, which are all customizable to specific sponsor requirements. Altasciences assists sponsors in delivering better medications to those who need them more quickly.
For more information please visit: www.altasciences.com
About SiteOne Therapeutics
SiteOne Therapeutics is a clinical-stage biopharmaceutical company advancing novel therapeutics to treat hypersensitivity disorders. Since its foundation, 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