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SiteOne Announces Award of $5.3M Federal Grant from NIH / NIDA for the Development of a Novel Non-Opioid Analgesic

BOZEMAN, Mont., Oct. 10, 2019 /PRNewswire/ -- SiteOne Therapeutics, a privately-held biopharmaceutical company advancing novel non-opioid pain therapeutics, today announced that it has received a Notice of Award from the National Institute on Drug Abuse (NIDA) of the National Institutes of Health (NIH) for grant funding under the Helping to End Addiction Long-term, or the NIH HEAL Initiative, to support development of the Company's lead therapeutic candidate, ST-2427, a novel NaV1.7 sodium channel inhibitor for the treatment of acute post-operative pain.

"This grant represents a significant milestone for SiteOne as we continue to advance the ST-2427 program toward the clinic," said Stan E. Abel, Chief Executive Officer of SiteOne Therapeutics. "ST-2427 selectively blocks sodium channel NaV1.7, which has strong validation as a target for analgesic drug development based on human genetics. Importantly, ST-2427 will potentially block pain signals without affecting the central nervous system, thus avoiding the significant side effects and addiction potential of opioid pain medications. We are very grateful to NIDA and the NIH for this grant, which provides non-dilutive funding that will allow us to assess the potential of ST-2427 for the treatment of post-operative pain through Phase 2 proof-of-concept studies."

This grant 1UG3DA049599-01, titled "Development of a Potent and Highly Selective NaV1.7 Inhibitor for the Treatment of Acute Pain with the Goal of Reducing Opioid Use and Preventing Opioid Use Disorders," is a UG3/UH3 Phase Innovation Awards Cooperative Agreement involving two phases. The UG3 phase is to support a project with specific milestones to be accomplished by the end of a 2-year period. The UH3 phase will provide funding for a further 3 years to a project that successfully completed the milestones set in the UG3 phase. Application budgets are limited to $3 million direct costs per year and UG3 projects that have met their milestones will be considered by NIDA and prioritized for transition to the UH3 phase, with the total funding currently expected to be available under both the UG3 and UH3 phases to be a maximum of $15 million in direct costs.

"It's clear that a multi-pronged scientific approach is needed to reduce the risks of opioids, accelerate development of effective non-opioid therapies for pain and provide more flexible and effective options for treating addiction to opioids," said NIH Director Francis S. Collins, M.D., Ph.D., who launched the initiative in early 2018. "This unprecedented investment in the NIH HEAL Initiative demonstrates the commitment to reversing this devastating crisis."

SiteOne's Co-Principal Investigators for the grant are Dr. John Hunter, Chief Scientific Officer and Dr. Debra Odink, Chief Development Officer.

"The development of drugs targeting NaV1.7 has been challenging, due in part to the difficulty of achieving adequate selectivity for NaV1.7 over other closely related sodium ion channel isoforms," Dr. Hunter added. "Our approach, which leverages natural sodium channel inhibitors, has enabled the development of a robust pipeline of potent and selective drug candidates targeting NaV1.7. We believe that our lead compound, ST-2427 has transformative potential for the treatment of pain without opioids, and we look forward to beginning clinical studies, which we expect to initiate in 2020."

About SiteOne Therapeutics, Inc.
SiteOne Therapeutics is a private biopharmaceutical company headquartered in Bozeman, Montana with a research laboratory in South San Francisco, California. Since its inception, SiteOne has been dedicated to developing novel pain therapeutics to safely, effectively and efficiently treat acute and chronic pain without the significant addiction potential and side-effects of opioids. The company's therapeutic candidates are highly selective sodium ion channel 1.7 (Nav1.7) inhibitors based on naturally occurring small molecules. Given the urgent need for new, non-opioid solutions for managing pain, SiteOne is focused on advancing its lead product candidates for multiple therapeutic applications.

About the NIH HEAL Initiative
The Helping to End Addiction Long-termSM Initiative, or NIH HEAL InitiativeSM, is an aggressive, trans-NIH effort to speed scientific solutions to stem the national opioid public health crisis. Launched in April 2018, the initiative is focused on improving prevention and treatment strategies for opioid misuse and addiction, and enhancing pain management. For more information, visit: https://heal.nih.gov.

Contact:
SiteOne
info@site1therapeutics.com

Investors:
Burns McClellan
Lee Roth, 212-213-0006
lroth@burnsmc.com

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SOURCE SiteOne Therapeutics