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HARNESSING

THE POWER
TO HEAL

A promising portfolio covering a range of conditions

The diverse biologic properties and modes of administration of ST266 enable exceptionally broad therapeutic utility for ophthalmic indications. ST266 can be safely and effectively delivered to both the front of the eye and the back of the eye, thus enabling us to take full advantage of its anti-inflammatory and neuroprotective properties. In addition, the broad range of delivery options enable the use of ST266 for a number of inflammatory conditions.

Current Pipeline
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 or other conditions that are slow to heal—often as a result of a patient’s concomitant diabetes or an underlying immune deficiency. PEDs can lead to blindness.

PED is estimated to affect up to 100,000 patients in the U.S. (source: Wirostko, et al. 2015). It is considered an orphan drug indication. Currently, there is no FDA-approved drug that has been adopted as standard of care for healing PEDs.

Preclinical studies have shown that ST266 reduces eye inflammation in damaged corneas and enhances re-epithelialization by cells that form the cornea. Noveome is currently testing ST266 in an open-label Phase 2 PED trial.

Wet Age-Related Macular Degeneration

Age-related Macular Degeneration (AMD) is present in 10 million people in the USA and is a leading cause of blindness. Usually occurring after the age of 50 years, AMD is a degenerative process in the retina in the back of the eye resulting in loss of central vision. Most AMD, 85-90 percent, is “dry”; however, “wet” AMD involves leaking of fluid from the retina and while it only accounts for 10-15 percent of AMD cases, it causes 90 percent of blindness from AMD. Blindness from wet AMD is more common than blindness from DR and glaucoma combined.

VEGF, a protein normally found in the body, causes new blood vessel growth. Anti-VEGF drugs and laser treatments may slow the progressive vision loss from AMD. ST266, known to reduce inflammation and control swelling, may be able to preserve vision by its anti-inflammatory activities. Furthermore, ST266 can be delivered to the optic nerve and retina using non-invasive targeted intranasal delivery.

Glaucoma

Glaucoma is a progressive disease of the optic nerve in which elevated intraocular pressure damages the retinal ganglion cells resulting in irreversible vision loss and ultimately blindness. It affects approximately 77 million patients worldwide. Currently approved treatments for glaucoma reduce intraocular hypertension but do not treat the underlying optic nerve degeneration.

In preclinical studies, ST266 has been shown to be neuroprotective and to resuscitate damaged and diseased retinal ganglion cells, offering the possibility of a novel treatment for glaucoma.

Optic Neuritis

Optic neuritis is an inflammatory disease of the optic nerve and is frequently the presenting sign of multiple sclerosis. These patients commonly experience pain on eye movement and then suddenly have a major loss in visual acuity, usually in one eye. The blindness often resolves in 6-8 weeks. Six months after the episode of blindness, more than half of the patients have some visual changes, including deficits in color vision, contrast sensitivity, and light brightness. The current treatment is steroids, which reduce the period of visual acuity loss but have little or no effect on the preventing damage to contrast vision.

Over time, relapses of this inflammation can lead to vision loss and potentially permanent blindness due to damaged optic nerve cells. In preclinical studies using a model which mimics optic neuritis and multiple sclerosis, ST266 administered by intranasal delivery has been shown to restore vision when given even as late as 2 to 3 weeks after the disease has been induced (Khan, et al. 2017, Khan, et al. 2019). These findings offer hope for preservation of vision in patients with optic neuritis and other optic nerve and retinal diseases.

Polytrauma

“Polytrauma” and “multiple trauma” are terms often used to describe the injuries to a person from violence, motor vehicle wrecks, falls, wars, or other accidents. In many cases there is also loss of blood. The organs injured are commonly skin, bones, brain, and internal organs of the chest and/or abdomen. At a time when deaths from cancer or heart disease are decreasing, death from polytrauma is increasing. Alcohol is often a factor in these accidents and deaths. Each year, over 200,000 people die from multiple trauma with many more people injured. Deaths can be reduced by life-saving measures including early diagnosis, resuscitation, control of bleeding, and treatment of the injuries.

Early in the course of multiple injuries, there is an inflammatory reaction which can lead to multi-organ failure, sepsis, and death. Preclinical studies of ST266 given systemically in polytrauma have shown the potential benefits of controlling inflammation and resuscitating damaged tissues in the early period after an injury.

Systemic Inflammatory Response

This program is based on a body of evidence demonstrating that ST266 significantly reduces the body’s inflammatory response in a wide range of diseases and conditions and has been shown to be safe and effective in humans. Importantly, preventing or reducing the severe cytokine storm associated with COVID-19 and other inflammatory conditions could provide a crucial treatment that will improve patient outcomes.

Chronic Traumatic Encephalopathy (CTE)

CTE is a progressive degenerative disease of the brain linked to repetitive head trauma. It is frequently seen in athletes and combat soldiers. A recent study published in the Journal of the American Medical Association (JAMA) found CTE in 99% of brains obtained from autopsies of National Football League (NFL) players, as well as 91% of those from college football players and 21% of those from high school football players (Mez, et al. 2017).

Preclinical studies have shown that ST266 attenuates the neurodegeneration and inflammation of penetrating ballistic brain injuries, a model of gunshot wounds and other open-head traumatic brain injuries (Deng-Bryant, et al. 2015). It has also been shown that CTE involves formation of extensive tau aggregate deposits, the same deposits seen in other neurodegenerative conditions such as Alzheimer’s disease. As many of the same pathways are involved in closed-head traumatic brain injuries, it is hoped these findings will translate into similar positive effects in CTE. ST266 can be given by intranasal delivery for CTE and all other central nervous system (CNS) indications.

Glaucoma

Glaucoma is a progressive disease of the optic nerve in which elevated intraocular pressure damages the retinal ganglion cells resulting in irreversible vision loss and ultimately blindness. It affects approximately 77 million patients worldwide. Currently approved treatments for glaucoma reduce intraocular hypertension but do not treat the underlying optic nerve degeneration.

In preclinical studies, ST266 has been shown to be neuroprotective and to resuscitate damaged and diseased retinal ganglion cells, offering the possibility of a novel treatment for glaucoma.