Noveome to conduct Phase 2b trial of ST266 in Persistent Corneal Epithelial Defects
PITTSBURGH—June 12, 2020—Noveome Biotherapeutics, Inc., a clinical stage biopharmaceutical company developing next-generation biologics for the promotion and restoration of cellular integrity of inflamed or damaged tissues, today announced positive data from its Phase 2, multi-center, open-label clinical trial of ST266 in patients with persistent corneal epithelial defects (PEDs). These data were published today as an online presentation for the Association for Research in Vision and Ophthalmology (ARVO) 2020 Online Presentations and its associated platform, ARVOLearn.
“There remains a clear unmet need for patients suffering from PEDs as there is no gold standard for treating this condition. These non-healing wounds can lead to serious consequences such as infections and blindness, which makes identifying an effective treatment all the more critical,” said Lead Investigator Bennie H. Jeng, M.D., Chair of the Department of Ophthalmology and Visual Sciences at the University of Maryland School of Medicine. “While additional research is necessary to ensure the efficacy and safety of ST266 in treating PEDs, it is encouraging to see initial data that validate the potential for ST266 in this challenging condition.”
Corneal defects are classified as persistent when the defect has not healed within 14 days. There are many different causes of PEDs, and treatment varies depending on the etiology. As commonly used treatments such as autologous serum and amnionic membranes are not always successful, patients are at risk for permanent vision loss. Noveome’s Phase 2 multi-center, open-label clinical trial was designed to evaluate the safety and efficacy of topical delivery of ST266 in patients with PEDs. Each study eye received a total of four drops per day of ST266 over the course of 28 days.
At data cutoff for this analysis, 11 patients had been enrolled in the study. Of the 11 enrolled patients, 10 completed treatment. All 10 eyes demonstrated response to treatment by day 28 with significantly decreased size (p=0.001). Three eyes had complete healing during the 28-day treatment window. One of the three eyes with complete healing on day 21 had a re-opening on day 28; however, the PED was almost completely healed by day 35 of the study. The remaining 7 eyes all had smaller areas of defect compared with baseline. No drug-related serious adverse events (SAEs) were reported. One patient withdrew for reasons deemed unrelated to the trial or study drug.
These early results suggest that ST266 may be effective in healing PEDs that have been refractory to standard therapies. They are consistent with pre-clinical studies, in which ST266 treatment was associated with reduced inflammation, decreased neutrophil infiltration, and increased re-epithelization in a rabbit model for corneal incision and abrasion.
“Treating PEDs is just one of the many exciting uses we have identified for ST266, and it is promising to see this positive result. We will continue to advance this program alongside our diverse pipeline aimed at providing patients across multiple disease areas with safe and effective therapies,” said William Golden, Founder, Chairman and CEO of Noveome. “We look forward to further exploring ST266 for this indication in a Phase 2b masked, placebo-controlled trial in PEDs we are currently planning.”
About ST266
ST266 is a cell-free biologic made by culturing a novel population of human amnion-derived cells. Through a proprietary culturing method, these cells produce an array of growth factors and cytokines, known as the secretome, which promote cellular survival and reduce inflammation.
About Noveome Biotherapeutics, Inc.
Based in Pittsburgh, PA, Noveome Biotherapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing next-generation biologics for the promotion and restoration of cellular integrity of inflamed or damaged tissues. Noveome has launched a program to test its novel platform biologic, ST266, as a treatment for the severe inflammatory response seen in COVID-19 infection. In addition to the Phase 2 open-label clinical trial evaluating the efficacy of ST266 in healing persistent corneal epithelial defects (PEDs) reported here, ST266 is also being evaluated in a Phase 1 open label clinical trial to establish the safety of ST266 in intranasal transcribriform delivery from nose to brain and eye. Noveome is also currently planning follow-up clinical studies to characterize the efficacy and safety of ST266 further for the treatment of PEDs. For more information, visit www.noveome.com.
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