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September 17th, 2018, Stuart, Florida
For Immediate Release
Stuart Therapeutics, Inc. (Stuart), a pre-clinical stage company developing advanced ophthalmic therapeutics, announced important pre-clinical in vivo proof of concept results for its collagen mimetic polypeptide therapeutic, PolyColTM (PolyCol). Mouse eye wound tests conducted at the University of Louisville demonstrated rapid, high quality healing of corneal wounds, results that support Stuart’s development of PolyCol as a potential therapeutic for dry eye disease (DED) and other ocular surface indications. The results showed:
- Statistically significant acceleration of epithelial renewal compared with controls.
- Statistically significant adherence of epithelium to Bowman’s layer compared with controls. Adherence is similar to unwounded corneas.
- Complete or near complete reduction of fluorescein staining (used to visually demark the perimeter of the wound and inflammation) within 24 hours.
PolyCol has demonstrated in several, ex vivo and in vivo tests that it targets, anchors to, and repairs damaged collagen. This behavior is particularly important in ophthalmology, given the significant presence of collagen in the stroma of the eye and adjacent tissues. Stuart is developing its first PolyCol product, ST-100, as a drop formulation for dry eye syndrome, to heal damage to the ocular surface caused by dry eye, providing rapid relief of signs and symptoms of the indication. Stuart believes that ST-100 should be broadly applicable to the estimated 30 million sufferers of dry eye symptoms in the United States, due to the direct reparative approach of PolyCol to painful damage to the surface of the eye.
The recent in vivo tests were conducted by creating a consistent wound covering over 70% of the exposed portion of the mouse eye. The mice were then treated with PolyCol, or with positive or negative control solutions. The eyes were collected at sacrifice and histologically examined at high magnification for epithelial recovery, adherence of the epithelium to Bowman’s layer, and stromal recovery and healing.
These results appear to demonstrate compelling healing rates for eye wounds and ocular surface damage in a variety of indications.
“These results show important and new capabilities that may ultimately relieve a wide variety of painful indications on the surface of the eye, for which there are very few options for physicians,” said Eric Schlumpf, President and CEO of Stuart Therapeutics, Inc. “As a result of these tests, we will be accelerating our development of PolyCol first as a dry eye disease therapeutic, followed by other ocular surface indications.”
About Stuart Therapeutics:
Stuart Therapeutics is a pre-clinical stage pharmaceutical company focused on the development of PolyCol, a collagen mimetic peptide therapeutic platform. The company is developing ophthalmologic applications for this technology and others.
ST-100 is a candidate therapeutic that is in pre-clinical evaluation and has not been approved by the U.S. Food and Drug Administration (FDA) for use in treating, preventing, curing or diagnosing any disease or disorder. Similarly, the statements contained in this Announcement have not been evaluated by the FDA, and may be considered “forward-looking statements” under applicable securities laws. Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements. Although forward-looking statements contained in this presentation are based upon what management of Stuart Therapeutics believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Stuart Therapeutics undertakes no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.
Stuart Therapeutics, Inc.