Stuart Therapeutics Announces Successful Outcome from Type C Meeting with FDA

STUART, Fla., July 18, 2022 /PRNewswire/ — Stuart Therapeutics, Inc. (Stuart), a clinical stage company headquartered in Stuart, Florida that is developing advanced ophthalmic therapeutics, announced today the results of its Type C Guidance meeting with the U.S. Food and Drug Administration (FDA) regarding the continued development plan for ST-100, Stuart’s first drug candidate for the treatment of Dry Eye Disease (DED) in humans. Stuart provided the FDA with the results of the ST-100 Phase 2 clinical trial, completed late last year, and asked for the agency’s guidance relating to the company’s proposed next steps, including a Phase 3 clinical trial and associated endpoints for ST-100.  The FDA provided Stuart with its acceptance of the company’s plan to conduct a Phase 3 trial for ST-100, along with approval of the proposed endpoints which include a single primary endpoint (Schirmer’s Responder Rate) and a series of secondary endpoints proposed by the company.  In addition, the FDA accepted the overall development plan proposed by Stuart.

Stuart Therapeutics, Inc. announces results of its Type C meeting with FDA

Based on the FDA’s positive response to Stuart’s Type C meeting submittal, the company anticipates proceeding with a Phase 3 clinical trial on ST-100 in early 2023.

“The FDA feedback we received is welcome and allows us to proceed as planned to a Phase 3 clinical trial for ST-100 in the first quarter of 2023.  The clarity of the results we achieved in a small population (160 patients) Phase 2 trial late last year puts us in a strong position.  The rapid, systematic Schirmer’s test results, achieved in 28 days, coupled with strong symptom relief at day 14, position ST-100 as a potential leader in the treatment of ocular surface disease,” said Bob Baratta, MD, Chairman and Chief Medical Officer of Stuart.

ST-100 is an eyedrop formulation that is based on Stuart’s patented Collagen Mimetic Peptide platform, PolyCol^™ (PolyCol). Pre-clinical animal testing has demonstrated that ST-100 provides rapid repair of damaged corneal epithelial and sub-epithelial tissues in the eye, coupled with restoration and protection of corneal nerve structures, making it an ideal therapeutic candidate for DED and possibly for other ocular surface indications. Stuart believes that ST-100 should be broadly applicable to the estimated 30 million sufferers of dry eye disease in the United States, due to ST-100’s apparent ability to alleviate painful eye surface damage that is a hallmark of DED. “The result of this meeting with the FDA is that Stuart can move quickly into a larger (300+ patients) Phase 3 clinical trial to further demonstrate the safety and efficacy of ST-100 for the treatment of dry eye disease. This outcome represents continued confirmation of the success of our strategy to move ST-100 through the clinical trial process, and we thank the Stuart development team and our outside partners and advisors for the part they played in bringing us to this point,” said Eric Schlumpf, President & CEO of Stuart Therapeutics.

About Stuart Therapeutics:

Stuart Therapeutics is a clinical stage pharmaceutical company focused on the development of PolyCol, a collagen mimetic peptide therapeutic platform. The company is developing a variety of anterior and posterior segment ophthalmologic applications based on the PolyCol technology.

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.