Noveome Biotherapeutics has started dosing patients in a Phase II clinical trial of topical ocular delivery of ST266 to treat persistent corneal epithelial defects (PEDs).
PEDs are non-healing wounds of the cornea caused by trauma, surgery and infection. The condition has limited treatment options.
ST266 is a cell-free platform biologic made up of several proteins and additional factors related to cellular healing, protection of the brain and nerves, and modulation of inflammation.
The therapeutic’s components are secreted by a population of cells that are produced using amnion-derived epithelial cells extracted from full term placentas.
According to Noveome, this secretome comprises physiologic levels of a range of growth factors and cytokines. It was found to induce various anti-inflammatory and neuroprotective responses in preclinical studies.
ST266 is being developed in ophthalmologic, central nervous system (CNS), pulmonary and gastrointestinal conditions.
The open label, multi-centre Phase II study will investigate the safety and efficacy of topical delivery of the compound in around 20 subjects with PEDs.
Each patient will be administered with four doses of ST266 per day in the study eye over 28 days. Primary endpoint of the trial is complete healing assessed using fluorescein dye after 28 days of treatment.
Noveome Biotherapeutics founder, chairman and CEO William Golden said: “We believe that ST266 has the potential to provide an innovative treatment option as a novel cell-free platform biologic based on the results we have seen to date in both preclinical and clinical trials demonstrating a strong safety profile.
“In this trial, we will measure both the magnitude and speed of response, as well as the number of completely healed patients and the time to complete healing in the study eye of PED patients.”
The company expects to report top-line data from the Phase II trial later this year.