Noveome Biotherapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing next-generation biologics for the promotion and restoration of cellular integrity of inflamed or damaged tissues, today announced the dosing of the first patient in its Phase 2 open label, multi-center clinical trial evaluating topical ocular delivery of ST266 for the treatment of persistent corneal epithelial defects (PEDs), for which there are limited treatment options.
“The dosing of the first patient in our Phase 2 clinical trial marks an important milestone for Noveome as we continue to explore ST266’s safety, efficacy and broad therapeutic applicability. 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,” said William J. Golden, Founder, Chairman and Chief Executive Officer of Noveome. “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 Phase 2 open label, multi-center clinical trial will evaluate the safety and efficacy of topical delivery of ST266 in patients with PEDs. The primary endpoint of the clinical trial is to complete healing as determined by fluorescein dye after 28 days of therapy. Each patient will receive a total of 4 doses per day of ST266 over the course of 28 days in the study eye. More information about the study is available at www.clinicaltrials.gov under the identifier NCT03687632. Topline results are expected later in 2019.
About Persistent Corneal Epithelial Defects (PEDs)
PEDs are non-healing wounds of the cornea caused by trauma, surgery and infection for which there are limited treatment options. Failure of the epithelial cells in the cornea to migrate and close the wound can lead to scarring and possibly perforation and blindness, especially in patients with severe dry eye and diabetes.
ST266 is a cell-free “platform” biologic containing hundreds of proteins and other factors involved in cellular healing, protection of the brain and nerves, and modulation of inflammation. The components of ST266 are secreted by a novel population of cells generated by a proprietary method of culturing amnion-derived epithelial cells collected from full term placentas, which are normally discarded after birth. This “secretome” contains physiologic levels of multiple growth factors and cytokines and stimulates a variety of anti-inflammatory and neuroprotective responses in preclinical studies. In addition to central nervous system (CNS) conditions, ST266 is being evaluated in ophthalmologic, pulmonary and gastrointestinal conditions. The ST266 platform biologic enables the use of a scalable manufacturing process to produce quantities for all indications, A drug master file has been submitted with the FDA, supporting all ST266 investigational new drug (IND) applications.
About Noveome Biotherapeutics, Inc.
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’s multi-target platform biologic and lead product, ST266, is currently being evaluated in multiple indications across CNS, ophthalmic, pulmonary and gastrointestinal therapeutic areas. Noveome is planning to start a Phase 1 open label clinical trial to establish the safety of ST266 when delivered intranasally in 2Q 2019 as well as a Phase 2/3 clinical trial of ST266 in patients with cataracts in 4Q 2019. In addition to the clinical pipeline, preclinical results testing ST266 in chronic traumatic encephalopathy (CTE), emphysema and necrotizing enterocolitis (NEC) are also expected later in 2019. The Company received seed funding from Lancet Capital, a venture capital consortium of leading Pittsburgh healthcare institutions including UPMC Enterprises, Highmark Blue Cross/Blue Shield, University of Pittsburgh and Carnegie Mellon University. To date, Noveome has received over $120 million in research and infrastructure funding from the U.S. Department of Defense, the Commonwealth of Pennsylvania and Allegheny County. Noveome is based in Pittsburgh, PA. For more information, please visit, www.noveome.com.
SOURCE: Noveome Biotherapeutics