{"id":4560,"date":"2021-09-08T14:28:17","date_gmt":"2021-09-08T14:28:17","guid":{"rendered":"https:\/\/stuarttherapeutics.com\/?p=4560"},"modified":"2021-09-15T17:21:23","modified_gmt":"2021-09-15T17:21:23","slug":"stuart-therapeutics-inc-announces-completion-of-patient-enrollment-in-phase-2-clinical-trial-for-dry-eye-disease","status":"publish","type":"post","link":"https:\/\/stuarttherapeutics.com\/stuart-therapeutics-inc-announces-completion-of-patient-enrollment-in-phase-2-clinical-trial-for-dry-eye-disease\/","title":{"rendered":"Stuart Therapeutics, Inc. Announces Completion of Patient Enrollment in Phase 2 Clinical Trial for Dry Eye Disease"},"content":{"rendered":"

Stuart Therapeutics, Inc. Announces Completion of Patient Enrollment in Phase 2 Clinical Trial for Dry Eye Disease<\/h4>\n

STUART, Fla.<\/span>, Sept. 8, 2021<\/span> \/PRNewswire\/ — Stuart Therapeutics, Inc. (“Stuart<\/span>“), a clinical stage biopharmaceutical company conducting research and development of unique peptide therapeutics for ophthalmic diseases, today announced\u00a0that it has completed patient enrollment in its Phase 2 clinical trial to evaluate the efficacy of its drug candidate ST-100, administered topically to Dry Eye Disease (DED) patients. \u00a0DED is a common indication affecting 20 million people in the United States<\/span> alone, and 344 million worldwide. \u00a0It is a multifactorial disease, with a significant unmet need. \u00a0The multi-center, randomized, double masked, placebo-controlled study, assessing the safety and efficacy of ST-100 ophthalmic solution in subjects diagnosed with DED, will evaluate two different dose levels versus placebo.\u00a0 The company has enrolled 150 volunteers in the study, which is being conducted with the support of Stuart’s<\/span> strategic partner and CRO, Ora, Inc.\u00a0 ST-100 is based on PolyColTM<\/sup> (PolyCol<\/i><\/b>), the company’s synthesized polypeptide tissue reparative platform.<\/p>\n

“Today’s ‘Last-Patient-In’ announcement is a major milestone for our company,” said Stuart’s<\/span> President and CEO, Eric Schlumpf<\/span>. \u00a0“This is another important step in the development of the PolyColTM <\/sup>(PolyCol<\/i><\/b>) platform for ophthalmic indications.\u00a0 We are pleased to share this news with our investors and stakeholders.”<\/p>\n

PolyCol<\/i><\/b>\u00a0is a platform technology comprised of synthesized polypeptides that mimic key amino acid sequences found in extra-cellular matrix collagen in the body.\u00a0 They act as a rapid direct reparative to disease damaged collagen and are applicable where disease or trauma impacts vital cells and their underlying collagen-containing structures.\u00a0 Based on Stuart’s<\/span> pre-clinical research results, PolyCol<\/i><\/b> appears to improve and accelerate the recovery and repair of the cellular structures dependent upon collagen; and reduce inflammation.\u00a0 Stuart<\/span> controls the worldwide rights for the PolyCol<\/i><\/b> technology platform in ophthalmology therapeutics.<\/p>\n

“We are deeply grateful to the team at Ora, and the three clinical trial centers that have worked diligently to enroll and treat patients in this study, and to our three investigators, Drs. Torkildsen, Jordan<\/span>, and Evans.\u00a0 We also thank our participating patients for their commitment of time and energy to this study,” said Bob Baratta<\/span>, MD, Stuart’s<\/span> Chairman and Chief Medical Officer.<\/p>\n

About ST-100
<\/b>ST-100 is a topically administered drop formulation based on the\u00a0PolyCol<\/i><\/b>\u00a0family of collagen mimetic peptides.\u00a0 These peptides are designed to repair damaged collagen in disease-affected tissues, and to restore normal cell signaling behavior.\u00a0\u00a0PolyCol<\/i><\/b>\u00a0has been shown in multiple\u00a0in vitro<\/i>\u00a0and\u00a0in vivo<\/i>\u00a0pre-clinical studies to provide rapid healing and reduction in inflammation in ocular tissues.\u00a0 ST-100 has the potential to offer rapid relief from both signs and symptoms of dry eye disease.<\/p>\n

About Ora, Inc.
<\/b>Ora is the world’s leading full-service ophthalmic research organization with offices in the United States<\/span>, United Kingdom<\/span>, Australia<\/span>, and Asia<\/span>. For over 40 years, Ora has helped their clients earn 48 product approvals. Ora supports a wide array of organizations, from start-ups to global pharmaceutical and device companies, to efficiently bring their new products from concept to market. Ora’s unique models, methodologies, and global regulatory strategies have been refined and proven across thousands of global projects. Ora brings together the world’s most extensive and experienced team of ophthalmic experts to maximize the value of new product initiatives. For more information, visit oraclinical.com<\/a><\/u>.<\/p>\n

About Stuart Therapeutics, Inc.
<\/b>Stuart Therapeutics, Inc. is a clinical-stage biopharmaceutical company conducting research and development of unique synthesized peptides as potential therapeutics for ophthalmic diseases. \u00a0The company is developing the PolyCol<\/i><\/b> platform for several major chronic eye disease indications, including dry eye disease, glaucoma, and dry age-related macular degeneration.<\/p>\n

Contact: Eric Schlumpf<\/span>, President & CEO, 772-678-7307, eric@stuarttherapeutics.com<\/a><\/u>, stuarttherapeutics.com<\/a><\/u><\/p>\n

SOURCE Stuart Therapeutics<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"

Stuart Therapeutics, Inc. Announces Completion of Patient Enrollment in Phase 2 Clinical Trial for Dry Eye Disease STUART, Fla., Sept. 8, 2021 \/PRNewswire\/ — Stuart Therapeutics, Inc. (“Stuart“), a clinical stage biopharmaceutical company conducting research and development of unique peptide therapeutics for ophthalmic diseases, today announced\u00a0that it has completed patient enrollment in its Phase 2…<\/p>\n","protected":false},"author":1,"featured_media":4561,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_mi_skip_tracking":false},"categories":[33],"tags":[42,43,41,40,38,35],"_links":{"self":[{"href":"https:\/\/stuarttherapeutics.com\/wp-json\/wp\/v2\/posts\/4560"}],"collection":[{"href":"https:\/\/stuarttherapeutics.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/stuarttherapeutics.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/stuarttherapeutics.com\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/stuarttherapeutics.com\/wp-json\/wp\/v2\/comments?post=4560"}],"version-history":[{"count":0,"href":"https:\/\/stuarttherapeutics.com\/wp-json\/wp\/v2\/posts\/4560\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/stuarttherapeutics.com\/wp-json\/wp\/v2\/media\/4561"}],"wp:attachment":[{"href":"https:\/\/stuarttherapeutics.com\/wp-json\/wp\/v2\/media?parent=4560"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/stuarttherapeutics.com\/wp-json\/wp\/v2\/categories?post=4560"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/stuarttherapeutics.com\/wp-json\/wp\/v2\/tags?post=4560"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}