PITTSBURGH--(BUSINESS WIRE)-- 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 publication of preclinical results evaluating the neuroprotective properties of fractionated and unfractionated ST266 in the journal PLOS ONE.

The studies demonstrated that the complete ST266 secretome is required to obtain the full neuroprotective and myelin-protective effects in the experimental autoimmune encephalomyelitis (EAE) mouse model of optic neuritis. The research was conducted in the laboratory of Kenneth S. Shindler, MD, PhD, an associate professor of Ophthalmology and Neurology in the Perelman School of Medicine at the University of Pennsylvania in Philadelphia.

“Noveome has shown that when ST266 is administered using the intranasal nose to brain route, it can attenuate visual dysfunction, prevent retinal ganglion cell loss, and reduce both inflammation and demyelination of optic nerves six weeks after induction of EAE in mice,” said Larry Brown, Sc.D., Noveome’s Chief Scientific Officer. “In this study, we wanted to determine how specific molecular weight protein ranges impact neuroprotective activity.”

The publication, entitled “Mechanism of Neuroprotection Mediated by ST266 Requires full Complement of Proteins Secreted by Amnion-derived Multipotent Progenitor Cells,” highlights the comparison of the neuroprotective and myelin-protective effects of two molecular weight ST266 fractions, a <30kDa fraction and a <50kDa fraction, and the full complement ST266 in the EAE model. The experiments evaluated retinal ganglion cell (RGC) survival in isolated retinas and assessed optic nerves for inflammation and demyelination. In addition, Schwann cell proliferation was evaluated in vitro.

The results demonstrated that the full complement of the ST266 secretome significantly improved RGC survival and reduced optic nerve demyelination in EAE mice. In contrast, the <50kDa molecular weight ST266 fraction significantly improved optic nerve demyelination, but only showed a trend towards improved RGC survival. Both the <30kDa and the <50kDa fractions increased Schwann cell proliferation in vitro but were less effective than full complement ST266. Demyelination attenuation was partially associated with the <50kDa fraction, but removal of higher molecular weight biomolecules from ST266 diminished its neuroprotective effects, suggesting at least some high molecular weight proteins play a role in ST266-mediated neuroprotection.

In all, the results support intranasal nose to brain and eye delivery of ST266 as a candidate neuroprotective therapy for optic neuritis. For more information about Noveome’s interest in optic neuritis and the other ophthalmological applications in its pipeline, visit www.noveome.com/pipeline.

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. In addition to the Phase 1 trial described above, the company recently announced the results of a Phase 2 open-label clinical trial evaluating ST266 as a treatment for Persistent Corneal Epithelial Defects (PEDs). ST266 was found to be both safe and beneficial in treating PEDs. Additional clinical trials are being planned, including a Phase 2b PED trial and a Phase 2 wet Age-related Macular Degeneration trial. Noveome recently initiated a clinical program to evaluate the ability of ST266 to treat the severe inflammatory response called “cytokine storm” that occurs in some COVID-19 patients. This Phase 1 intravenous trial on COVID-19 patients is expected to begin in the first quarter of 2021. To date, Noveome has received over $160 million in research and infrastructure funding. Noveome is based in Pittsburgh, PA. For more information, please visit Noveome.com.

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