SiteOne Therapeutics to Present Research Findings for Selective Small Molecule Nav1.7 Inhibitors at the 2018 World Congress on Pain

SiteOne Anticipates Filing IND for Lead Candidate by Year-End 2018

BOZEMAN, Montana, Thursday, July 19, 2018 — SiteOne Therapeutics, a private biopharmaceutical company advancing novel non-opioid pain therapeutics, announced today that the Company will present new preclinical data from its program developing novel selective small molecule Nav1.7 Inhibitors at the 17th World Congress on Pain®, scheduled to take place in Boston, Massachusetts, September 12-16, 2018. The poster will feature data supporting advancement of SiteOne’s lead candidate for which the Company expects to file an IND submission by year end 2018.

“We are pleased that our preclinical results will be featured in an international scientific meeting this year,” stated John Mulcahy, PhD, Co-inventor and Vice President of Research at SiteOne. “Since the inception of SiteOne Therapeutics, our team has prepared hundreds of new molecular entities targeting a unique binding site on Nav1.7.  Optimization of potency and selectivity has yielded compounds exhibiting nanomolar potency and >1000 fold selectivity over other isoforms.”

About Nav1.7

Nav1.7 is a voltage-gated sodium channel that plays a critical role in the generation and conduction of action potentials in sensory neurons and is required for the initiation of pain signals. Humans who are born with loss-of-function mutations in the gene encoding Nav1.7 cannot experience most types of pain, and conversely, those with a gain-of-function mutation of the Nav1.7 gene experience increased pain states. There has been immense interest in Nav1.7 channel blockers that have the potential to produce strong analgesia in acute and chronic pain while reducing the side effects associated with local anesthetics, opioids, or NSAIDs.

About SiteOne Therapeutics, Inc.

SiteOne Therapeutics is headquartered in Bozeman, Montana with a research laboratory in South San Francisco, California.  SiteOne is dedicated to developing novel pain therapeutics to safely, effectively and efficiently treat acute and chronic pain without the limitations of existing pain therapies, such as NSAIDs or 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 critical role Nav1.7 plays in the generation and conduction of pain signals, combined with the urgent need for new, non-opioid pain therapies, SiteOne is focused on advancing its lead products to serve patients that suffer from moderate to severe pain.  For more information, visit SiteOne’s Web site at www.siteonetherapeutics.com.

Contact:
SiteOne Therapeutics, Inc.
info@site1therapeutics.com

 Investors:
Burns McClellan
Jill Steier, 212.213.0006
jsteier@burnsmc.com

Acclaimed Scientists and Physicians Join the Scientific Advisory Board of SiteOne Therapeutics to Help Guide the Advancement of Novel Non-Opioid Pain Therapeutics

Bozeman, MT – SiteOne Therapeutics, a private biopharmaceutical company advancing novel non-opioid pain therapeutics, today announces the addition of some of the world’s leading medical and scientific experts in the treatment of acute and chronic pain to its Scientific Advisory Board.  

“Our research and development team has made tremendous progress with our portfolio of novel, small molecule Naᵥ1.7 inhibitors for the treatment of acute and chronic pain,” said Stan Abel, President and Chief Executive Officer of SiteOne Therapeutics.  “Having access to such an outstanding team of scientific advisors is critical as we accelerate the development of these promising drug candidates.” 

“SiteOne’s therapeutic candidates exhibit impressive potency and selectivity for NaV1.7, and engage the target in a way that differentiates them from other inhibitors of Nav1.7. Their compounds show great promise as novel, non-opioid solutions for the treatment of pain” added Dr. Stephan G. Waxman, MD, PhD, Chair of the SiteOne Therapeutics Scientific Advisory Board.  “We look forward to working with the SiteOne team as they advance these drug candidates to clinical trials.”

Members of the SiteOne Therapeutics Scientific Advisory Board:

Stephen G. Waxman, MD, PhD (Chair)

  • Bridget Marie Flaherty Professor of Neurology, Neuroscience, and Pharmacology;
  • Chairman, Department of Neurology (1986-2009), Yale University School of Medicine;
  • Director, Center for Neuroscience & Regeneration Research, Yale University School of Medicine

Martin S. Angst, MD

  • Professor, Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine;  
  • Founder/Director Human Experimental Pain Laboratory (1996-2011), Department of Anesthesia Stanford University School of Medicine;
  • Leader Perioperative Immune Health Initiative, Department of Anesthesia Stanford University School of Medicine;

Anthony Ford, PhD

  • Neuroscientist and drug discovery entrepreneur
  • Founder / Chief Scientific Officer Afferent Pharmaceuticals (acquired by Merck 2016)
  • Former Vice President, Research, Head of Neuroscience, Roche Palo Alto

Frank Porreca, PhD

  • Professor and Associate Department Head, Pharmacology, University of Arizona
  • Professor, Anesthesiology, Cancer Biology – GIDP, Neuroscience – GIDP, Pharmacology

Michael C. Rowbotham, M.D.

  • Scientific Director, California Pacific Medical Center Research Institute
  • Adjunct Professor of Anesthesia, UCSF
  • Attending Physician, UCSF Pain Management Center
  • Emeritus Professor of Clinical Neurology, UCSF

In January 2017, SiteOne announced the closing of a research and development agreement with Amgen, a collaboration focused on combining SiteOne’s experienced drug discovery team and portfolio of novel Naᵥ1.7 inhibitors with Amgen’s neuroscience capabilities.  At the same time, SiteOne announced the closing of a $15 million series B round of financing, led by Amgen and joined by founding investors Next Frontier Capital, 2M Companies Inc., Mission Bay Capital, Sears Capital Management, Biobrit LLC, and Z Investments.   

About SiteOne Therapeutics

SiteOne Therapeutics is headquartered in Bozeman, Montana with a research team based in South San Francisco, California.  SiteOne is dedicated to developing novel pain therapeutics to safely, effectively and efficiently treat acute and chronic pain without the limitations of existing pain therapies, such as NSAIDs or 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 critical role Naᵥ1.7 plays in the generation and conduction of pain signals, combined with the urgent need for new, non-opioid pain therapies, SiteOne is focused on advancing its lead products to serve patients that suffer from moderate to severe pain.  For more information, visit SiteOne’s Web site at www.site1therapeutics.com

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SiteOne Therapeutics Announces Abstract Presentation at the Association for Research in Vision and Opthamology

BOZEMAN, Montana - SiteOne Therapeutics, Inc., today announced a presentation at the Association for Research in Vision and Opthalmology (ARVO) meeting in Honolulu, Hawaii, April 29 to May 3, 2018. 

The abstract will present preclinical research using SiteOne’s novel sodium ion channel blockers showing corneal anesthesia, penetration into the ocular structures, and excellent tolerability after topical administration.  The study was conducted to inform development of a novel drug candidate to treat ocular pain associated with dry eye syndrome.

Accepted ARVO abstract is listed below:

Delwig, A. et al, “Evaluation of Selective NaV 1.7 Inhibitors for the Treatment of Ocular Pain” Abstract # 2908312, Poster Presentation.

About Ocular Pain Associated with Dry Eye Syndrome

Dry eye syndrome is a clinical diagnosis that encompasses a broad range of distinct conditions with unique etiologies that share signs and symptoms, the most common of which are sensations of burning, stinging, itching or grittiness in the eyes. The objective of our program is to develop a topical ophthalmic analgesic to safely and effectively treat ocular discomfort associated with the diagnosis of dry eye. This product would also be useful for treating other types of ocular pain, such as post-surgical pain and pain associated with acute corneal injuries or abrasions.

Existing therapeutics for dry eye include topical cyclosporine (Restasis) and lifitegrast (Xiidra). Both drugs address the inflammatory component of the disease by inhibiting activation of T-cells, however signs and symptoms of dry eye frequently persist.

The objective of our program is to advance a topical ophthalmic analgesic that reduces ocular discomfort associated with dry eye by targeting a voltage-gated sodium channel in the cornea, NaV1.7, and reducing corneal pain. Our product has the potential to be broadly effective in the ~30 million Americans suffering from dry eye regardless of the etiology because it addresses the discomfort rather than the heterogeneous physiologic cause. The analgesic would complement therapeutics that reduce inflammation or improve tear film, allowing the patient to be comfortable over weeks to months required for these therapies take effect. It would also be a useful treatment for postoperative pain following certain surgical procedure and acute ocular injuries, such as corneal abrasion.

About SiteOne Therapeutics, Inc.

SiteOne Therapeutics is a biotechnology company headquartered in Bozeman, Montana with a research laboratory in the 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 limitations of existing pain therapies, such as NSAIDs or 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.