SiteOne Therapeutics Receives NIH Grant to Support the Development of Novel Therapeutics to Treat Ocular Pain

Potential applications in pain associated with ocular surgery, injury, and Dry Eye Syndrome


BOZEMAN, Montana, Sept. 25, 2018 /PRNewswire/ -- SiteOne Therapeutics, a private biopharmaceutical company advancing novel non-opioid pain therapeutics, today announced the company has been awarded a $1.4 million, two-year, Phase 2 SBIR grant from the National Eye Institute (NEI), a member of the US National Institutes of Health (NIH).  The award will be used to initiate IND-enabling studies for SiteOne's Ocular NaV1.7 Program for pain associated with ocular surgery, injury and disease, such as Dry Eye Syndrome.  This is the third Phase 2 SBIR grant that SiteOne has received from the NIH, the first having been awarded in September 2014 to support the discovery and development of selective inhibitors of NaV1.7 as therapeutics for acute and chronic pain.

"This new award from NEI represents another important milestone for SiteOne as we continue to advance our portfolio of highly selective NaV1.7 inhibitors for pain," said Stan E. Abel, the company's Chief Executive Officer. "Our lead NaV1.7 program, an intravenous injection for the treatment of postoperative acute pain, is expected to enter clinical testing in 2019.  A subcutaneous program will also be advancing into preclinical evaluation later this year. For the ocular program, we anticipate filing an IND in 2020."

The company recently presented preclinical data, including promising tolerability and ocular tissue distribution, for its ocular pain program at the 2018 Association for Research in Vision and Ophthalmology Conference.  In this research, administration of a SiteOne selective NaV1.7 inhibitor in a preclinical in vivo model resulted in high ocular tissue exposure and tolerability.

 "A successful product for ocular pain that can be applied directly to the eye 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," said John Mulcahy, Ph.D., Vice President of Research at SiteOne. "The analgesic also would complement therapeutics that reduce inflammation or improve tear film, allowing the patient to be comfortable over weeks to months required for these therapies to take effect. Further applications include treatment for postoperative pain following refractive, cataract, and glaucoma surgeries (over 4 million procedures per year in the US) as well as the treatment of ocular injuries (over 2.5 million cases a year in the US)."

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.  There has been immense interest in developing selective NaV1.7 channel blockers as novel non-opioid analgesics which may provide pain relief without undesirable effects associated with current opioid therapeutics.

About SiteOne's Ocular Program
The absence of safe and effective strategies for the management of pain associated with various ocular conditions is motivating the development of a novel topical drug suitable for patient self-administration. Conventional local anesthetics, such as proparacaine, inhibit voltage-gated Na+ ion channels (NaV) and are highly effective for the management of ocular pain in acute, in-office settings. However, these agents are short acting and toxic to the corneal surface, which prevents their use beyond a few administrations. SiteOne has discovered a chemical series of novel, highly selective inhibitors of human NaV1.7, a subtype implicated by human genetics in the transmission of pain including ocular pain.  The absence of ocular pain in genetically null NaV1.7 individuals along with the excessive ocular pain in patients with NaV1.7 gain of function strongly suggests that selective inhibition of NaV1.7 is an important new therapeutic approach that can produce significant corneal and ocular pain relief without adverse effects resultant from inhibition of off-target sodium channels involved in vision, smooth muscle function and protective tearing and blinking reflexes. In research studies, ocular administration of NaV1.7 selective inhibitors were well-tolerated and lead to good intraocular exposure.

About SiteOne Therapeutics, Inc.
SiteOne Therapeutics is headquartered in Bozeman, Montana with a research laboratory in the 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, state-independent small molecule inhibitors of NaV1.7 that block the pore of the channel. 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 products to serve patients that suffer from moderate to severe pain.  For more information, visit SiteOne's web site at www.siteonetherapeutics.com.

Investors:
Burns McClellan
Jill Steier, 212-213-0006
jsteier@burnsmc.com

SiteOne Therapeutics Appoints Scott Braunstein, MD to Board of Directors

BOZEMAN, Mont., Sept. 12, 2018 /PRNewswire/ -- SiteOne Therapeutics, a private biopharmaceutical company advancing novel non-opioid pain therapeutics, today announced that Scott Braunstein, MD has been appointed to the Company's Board of Directors. Dr. Braunstein brings extensive leadership in sales, marketing and operations to SiteOne, as well as a successful track record of investing in biotech and pharmaceutical companies.

"We are very pleased to have Scott join our board of directors at such a pivotal time for SiteOne" said Stan Abel CEO of SiteOne Therapeutics. "Scott brings a wealth of experience in advancing and commercializing pain therapeutics. His experience in will be invaluable to our team as we continue to build SiteOne into a leading developer of non-opioid pain medicines."

Dr. Braunstein most recently served as the Chief Operating Officer at Pacira Pharmaceuticals. In this role Dr. Braunstein was responsible for overseeing sales, marketing, strategy and business development, playing an integral part in global licensing including securing a partnership with Johnson and Johnson in the United States for the Company's lead drug EXPAREL. During his time at Pacira, his roles included Chief Operating Officer, Chief Strategy Officer and SVP of Corporate Strategy and Development.

"I am honored to be appointed to the board of SiteOne Therapeutics and I look forward to working with my fellow board members and SiteOne's management team to help them accomplish their goal of developing a new class of effective non-opioid pain treatments" said Scott Braunstein.

Prior to Dr. Braunstein's role at Pacira, he served as a health care portfolio manager at Everpoint Asset Management. From 2002 through 2014 Dr. Braunstein was a healthcare analyst and managing director at J.P. Morgan Asset Management. Dr. Braunstein began his career as a practicing physician at the Summit Medical Group while also serving as assistant clinical professor at the Albert Einstein College of Medicine and for Columbia University Medical Center. Dr. Braunstein currently serves on the Board of Directors of ArTara Therapeutics and Esperion Pharmaceuticals and is an operating partner at Aisling Capital. Dr. Braunstein holds a bachelor's degree in business from Cornell University and earned his medical degree from the Albert Einstein College of Medicine.

About SiteOne Therapeutics, Inc.
SiteOne Therapeutics is a 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 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.

Contact:
Burns McClellan
Jill Steier, 212-213-0006
jsteier@burnsmc.com

 

SiteOne Therapeutics Appoints John Hunter, Ph.D. as Chief Scientific Officer

BOZEMAN, Montana, September 6th, 2018 — SiteOne Therapeutics, a private biopharmaceutical company advancing novel non-opioid pain therapeutics, today announced the appointment of John Hunter, Ph.D., as Chief Scientific Officer. Dr. Hunter is a highly-accomplished pharmaceutical research and development executive, having held multiple leadership positions within the pharmaceutical industry at Merck, Schering-Plough, Roche and Parke-Davis over the span of his 30-year career. In his role, Dr. Hunter will be responsible for advancing SiteOne’s portfolio of non-opioid drug candidates for the treatment of pain.

“John is a notable addition to our management team. His decision to join SiteOne at this stage in his career attests to our unique platform of first-in-class, highly potent and selective Nav1.7 inhibitors,” said Stan Abel CEO of SiteOne Therapeutics. “John has a wealth of knowledge in both neuroscience and drug development. His expertise will be invaluable as our pipeline of novel pain therapeutics progresses toward the clinic and our discovery platform continues to explore new indications.”

Prior to joining SiteOne Therapeutics, Dr. Hunter was most recently Vice-President of Research Science and Head of Discovery Research for the Cardio-Renal Therapeutic Area at Merck. Further roles within Merck included Vice President of Global Pharmacology, Screening & Protein Sciences and Vice-President and West Point Site Head for Discovery Research focused on the Neuroscience and Infectious Disease Therapeutic Areas. He was previously Vice-President of Neuroscience at Schering-Plough and Department Head of Pain Research and Systems Pharmacology at Roche Bioscience. During the course of his career, Dr. Hunter led multiple Discovery Research Project teams as well as early and late stage Clinical Development teams.

Dr. Hunter has published extensively, having authored more than 100 original scientific articles. He is currently a member of the International Association for the Study of Pain (IASP) and the Society for Neuroscience.

“SiteOne’s approach to targeting the Nav1.7 sodium ion channel is very unique and has tremendous potential to improve the standard of care in pain therapy,” said Dr. Hunter. “This is a very exciting time for SiteOne, and I look forward to working with the leadership team to achieve our goal of transforming the landscape of pain management.”

About SiteOne Therapeutics, Inc.
SiteOne Therapeutics is a biotechnology 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.

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

Investors:
Burns McClellan
Jill Steier, 212-213-0006
jsteier@burnsmc.com