Stuart Therapeutics, Inc. (Stuart), a pre-clinical stage company developing advanced ophthalmic therapeutics, announced today that it has successfully completed a pre-IND meeting regarding the development plan for ST-100, Stuart’s first drug candidate for Dry Eye Disease (DED). The meeting, held with the Food and Drug Administration’s Center for Drug Evaluation and Research, Division of Transplant and Ophthalmology Products, was completed remotely. FDA provided clear guidance with respect to Stuart’s proposed non- clinical and Chemistry Manufacture and Control (CMC) related programs as well as its clinical trial plans, and concurred with Stuart’s intent to proceed directly to Phase 2 clinical trials after submission of its IND. There were no concerns expressed by the agency with respect to the ST-100 molecule.
Based on the FDA’s positive response to Stuart’s pre-IND filing, the company anticipates filing an IND for ST-100 in mid 2020 and proceeding to initiate Phase 2 testing on DED patients. The Phase 2 endpoints proposed by Stuart in its pre-IND filing have been deemed acceptable by the agency.
“We are extremely pleased with the results of our discussion with FDA. We can confirm that the FDA agrees with our clinical development pathway and gave us clear guidance with respect to our overall plans. Following our meeting with FDA, we can confirm that ST-100 can move from IND filing directly into Phase 2 testing,” said Bob Baratta, MD, Chairman and Chief Medical Officer of Stuart.
ST-100, Stuart’s first drug candidate, is based on its patented Collagen Mimetic Peptide, PolyColTM (PolyCol) ST-100 has demonstrated in pre-clinical animal testing that it provides rapid repair of damaged corneal epithelial and sub-epithelial tissues in the eye, making it an ideal therapeutic candidate for DED and other ocular surface indications. Based on ST-100’s product profile, it is expected to be an extremely fast acting drop formulation therapeutic that can be complimentary to existing anti-inflammatory treatments. 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 to painful eye surface damage that is a hallmark of DED. “The result of this meeting is that Stuart can enter the clinic quickly, with minimum risk, consistent with our plans to demonstrate ST-100’s fundamentally new mechanism of action for the treatment of dry eye disease. This is an important confirmation of our planning and development with our team, partners and advisors. Stuart has made significant strides in just over a year of operation. The accomplishment of this milestone underscores the company’s commitment to bringing this exciting new approach to ocular surface disease to the market,” said Eric Schlumpf, President & CEO of Stuart Therapeutics.
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.
Email: [email protected]