Harrow Health, Inc. last week announced that its newly formed subsidiary, Stowe Pharmaceuticals, Inc., has entered into an agreement with TGV Health to acquire worldwide rights to the ZianTM anti-microbial molecule for ophthalmic and otic uses. ZianTM is a patented small molecule that is water soluble, colorless and odorless, and was developed to treat various complex bacterial, fungal, and viral infections, including in the eye and ear. The initial primary indication for Stowe’s initial drug candidates is expected to be adenoviral conjunctivitis, with secondary indications for mixed bacterial-viral infections, keratitis, endophthalmitis, and corneal ulcers.
“Currently, there is a large unmet need – globally – for a single medication that can treat various types of microbial ocular and otic infections. For example, there are no FDA approved drugs for use in the management of acanthamoeba keratitis and adenoviral Epidemic Keratoconjunctivitis (EKC),” said George Tets, MD, PhD, co-inventor of the ZianTM molecule. “In pre-clinical ophthalmic studies, our initial drug candidate based on the ZianTM molecule – STE-006 – successfully killed broad spectra of bacteria and inactivated ranges of viruses, including enveloped and non-enveloped viruses, within 15 seconds. We believe that if FDA-approved, STE-006 could potentially become a ‘one-stop-shop’ solution to quickly fight ophthalmic bacteria, fungi, and viruses, having sight-saving implications for people worldwide.”
Harrow Health board member and ophthalmologist Richard L. Lindstrom, MD, commented, “Serious sight threatening infections like acanthamoeba, fungal and bacterial keratitis, viral infections of the cornea and conjunctiva and endophthalmitis need better treatments. In many cases, if left untreated, these types of infections can and often do lead to blindness and other complications. Ocular infections are on the rise worldwide and anti-bacterial resistant pathogens are showing up in national headlines with increasing frequency. STE-006 has the potential to be an important weapon in our armamentarium against these threats.”
STE-006 is a patented small molecule topical drug candidate intended to treat various bacterial, fungal, and viral infections in the eye. In initial preclinical models, STE-006 was shown to be significantly more effective compared to current conventional therapies against numerous bacterial and viral pathogens, including strains of MRSA and herpes simplex virus. STE-006 has several patents issued in the U.S. and globally, covering matter of composition, methods of production, methods of use and molecule, which are valid until 2038. STE-006 is expected to pursue FDA approval via the 505(b)(1) pathway as a New Chemical Entity.