Top

advancing

the vision
to heal

A promising pipeline covering a range of complex conditions

Unlike traditional platform technologies, which use a foundational approach to discover and develop individual pipeline assets, ST266 is the platform and the portfolio. Its diverse biologic properties and modes of administration enable exceptionally broad therapeutic utility and the potential to treat and heal a range of complex diseases, conditions and injuries in ophthalmology, neurology, dermatology—and beyond. What’s more, by consolidating an entire portfolio in a single platform biologic, we can significantly reduce developmental risk and costs.

Current pipeline: Broad therapeutic potential via multiple mechanisms of delivery
Optic Nerve Diseases

Damage to the optic nerve can be caused by a variety of diseases and conditions including multiple sclerosis, glaucoma and trauma.

Optic neuritis is inflammation of the optic nerve and is often the presenting sign of multiple sclerosis. Over time, relapses of this inflammation can lead to vision loss and potentially blindness due to damaged optic nerve cells.

Glaucoma is a progressive disease in which elevated intraocular pressure (IOP) damages the optic nerve resulting in irreversible vision loss and ultimately blindness. It affects approximately 77 million patients worldwide. All currently approved treatments for glaucoma reduce IOP but do not treat the underlying optic nerve degeneration.

Optic nerve trauma causes damage to the optic nerve and can occur from falls, car accidents, sports injuries and military combat injuries.

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), demonstrated ST266 to be a potent neuroprotective agent for the optic nerve. As such, it represents a unique new class of medication that can protect—and potentially regenerate—critical optic nerve cells that are damaged as a result of optic nerve diseases or injury.

Noveome is using an innovative, targeted intranasal device capable of bypassing the blood-brain barrier to deliver ST266 directly to the optic nerve and brain, overcoming a major obstacle to successful treatment of these conditions.

Noveome is currently conducting a Phase I trial to confirm the safety of intranasally delivered ST266 in patients with intraocular hypertension (glaucoma suspect) who have not yet been diagnosed with glaucoma. This study will enable us to proceed with efficacy trials for the treatment of optic neuritis and glaucoma. Demonstration of the efficacy of ST266 in these trials may lead to its eventual use to treat other neurodegenerative diseases.

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.

Cataract Surgery

An estimated 4 million cataract operations are performed each year in the U.S. (source: Market Scope). Two common complications of cataract surgery are loss of corneal endothelial cells and posterior capsular opacification (PCO).

Corneal endothelial cells are non-replicative—and their loss can lead to a reduction in visual acuity. Corneal endothelial cell loss can be greater in patients with conditions such as diabetes. Up to 50% of cataract surgery patients experience PCO, in which the posterior portion of the capsule becomes hazy several months after surgery resulting in cloudy vision.

ST266 may reduce cataract surgery-linked endothelial cell loss, lower the risk of elevated intraocular pressure (IOP) associated with steroid use to treat inflammation, and reduce procedure-related scarring requiring laser repair.

Radiation Burns

Radiation burns of the skin are a common side effect of external beam radiotherapy for the treatment of cancer. These dermal burns are often severe, particularly when treating head-and-neck cancer or pelvic cancer, such that radiation treatments are sometimes interrupted to allow the patient time to recover.

When radiation therapy is interrupted, especially in head-and-neck cancer, the mortality may go up. There is no ideal preventive therapy to reduce the severity of radiation burns of the skin. ST266 has been shown to be anti-inflammatory and offers the possibility of reducing the severity of radiation burns, thereby lessening the pain, and thus improving survival by preventing the need for a break in the treatment regimen.

Trigeminal Neuralgia

Trigeminal Neuralgia is a rare disease of the fifth cranial nerve commonly seen in people over 50 years of age. Patients have severe pain in their face triggered by minor events such as brushing their teeth and lasting several minutes to several hours. The pain is sometimes on only one side. It interferes with activities of daily living because of fear of triggering an attack.

Treatments include surgery or medications such as anticonvulsants or antidepressants. Noveome can deliver its platform biologic ST266 intranasally to the trigeminal nerve.

Periodontal Disease

Periodontitis is a chronic inflammatory disease characterized by gingival bleeding, recession and detachment, which can ultimately lead to bone and tooth loss. It appears to be caused by an overproduction of proinflammatory cytokines within the gum tissues. Subsequent low-grade gum infections have been correlated to serious conditions, such as heart disease and diabetes. Periodontal disease is widespread with the prevalence of 3.5 million severe cases in the US annually—yet no significant improvement or advance in non-surgical therapy has taken place in the last 40 years.

ST266 presents a promising therapeutic option to significantly reduce proinflammatory cytokine levels within gum tissue. Used chronically, it may be able to reduce or even prevent periodontitis and its associated dangerous health consequences. Noveome has already completed Phase 1 and Phase 2a clinical studies with ST266, demonstrating its safety and ability to reduce inflammatory cytokines and disease-associated pathogens in gingivitis and periodontitis. A Phase 2b study is planned for 2020.