Optic Nerve Disease
Glaucoma is a progressive and highly individualized disease in which elevated intraocular pressure (IOP) damages the optic nerve resulting in irreversible vision loss and ultimately blindness. All approved treatments for glaucoma reduce IOP but do not treat the underlying degeneration of the optic nerve. ST266 represents a new and unique class of medication that protect the critical optic nerve cells. Noveome intends to deliver ST266 using an innovative targeted intranasal device that delivers ST266 to the optic nerve thereby bypassing the blood-brain barrier, a major hurdle in treating the optic nerve. Preclinical studies using both an animal model of multiple sclerosis/optic neuritis (Khan, et al. 2017) and of optic nerve trauma (Grinblat, et al. 2018) have demonstrated that ST266 is a potent neuroprotective agent for the optic nerve.
Chronic Traumatic Encephalopathy/CTE
CTE is a progressive degenerative disease of the brain associated with repetitive brain trauma such as may occur in warfighters and athletes. Preclinical studies have shown that ST266 attenuates neurodegeneration and inflammation in many of the same pathways of Traumatic Brain Injury that may lead to CTE (Deng-Bryant, et al. 2015). It has been shown that CTE involves formation of extensive tau aggregate deposits, the same deposits seen in other neurodegenerative conditions.
A recent study published in the Journal of the American Medical Association (JAMA) found CTE in 99 percent of brains obtained from autopsies of National Football League (NFL) players, as well as 91 percent of college football players and 21 percent of high school football players (Mez, et al. 2017).
Persistent Corneal Epithelial Defects (PEDs)
Wounds of the corneal surface of the eye usually heal within a week. PEDs are corneal wounds caused by infection, trauma, surgery, and other conditions that are slow to heal, especially if the patient has some impairment to healing such as diabetes. PEDs can lead to blindness. Currently, there is no FDA approved drug that is standard of care for healing of PEDs. Preclinical studies have shown that ST266 reduces eye inflammation in damaged corneas and enhances re-epithelialization by cells that form the cornea.
PED is considered an orphan drug indication and is estimated to affect up to 100,000 patients in the U.S. (source: Wirostko, et al. 2015).
Cataract Surgery Complications
Two common complications of cataract surgery are loss of corneal endothelial cells and posterior capsular opacification (PCO). Corneal endothelial cells are non-replicative, and the loss of these cells can lead to reduction in visual acuity Endothelial cell loss can be greater in patients with some conditions such as diabetes. In PCO, which occurs in up to 50 percent of patients, the posterior portion of the capsule becomes hazy several months after surgery resulting in cloudy vision. ST266 may reduce endothelial cell loss and reduce the risk of elevated intraocular pressure (IOP) associated with steroid use.
There are an estimated 4 million cataract operations each year in the U.S. (source: Market Scope).
Emphysema is a chronic disease involving the gradual damage of lung tissue, specifically thinning and destruction of the alveoli, usually caused by smoking or significant exposure to air pollution. There are no approved drugs that can protect and rebuild damaged lung tissue. ST266 has been shown to restore lung tissue in an animal model of emphysema.
The prevalence of emphysema in the U.S. is 3.5 million (source: www.cdc.gov).
Necrotizing Enterocolitis (NEC)
NEC is a leading cause of death in infants born preterm (before 37 weeks of pregnancy) or born with a low birth weight (less than 5.5 pounds). NEC may be associated with loss of exposure to amniotic fluid due to premature birth (Hackam, D.J. and Sodhi, C.P. (2018). Toll-Like Receptor–Mediated Intestinal Inflammatory Imbalance in the Pathogenesis of Necrotizing Enterocolitis. Cellular and Molecular Gastroenterology and Hepatology. 6. 10.1016/j.jcmgh.2018.04.001 There is no cure for this disease, and there has been no change in the mortality rate in 30 years. The population most at risk for NEC is increasing as technological advances in care of very low birth weight infants improve early survival. Because ST266 is derived from selected and cultured amnion cells, it may provide many of the same benefits as amniotic fluid.
There are around 480,000 infants born preterm each year in the U.S., all potentially at increased risk for NEC. The percentage of very low birth weight infants who develop NEC remains steady at about 7 percent (source: www.nichd.nih.gov).