SiteOne Therapeutics announced that the company has been awarded a $1.4 million, 2-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,” Stan E. Abel, Chief Executive Officer, SiteOne Therapeutics, said in a company news release. “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, PhD, 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).”
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.