ST-266

June 7, 2021 13:30 UTC Preliminary results show intranasally delivered ST266 is safe PITTSBURGH--(BUSINESS WIRE)-- Noveome Biotherapeutics., 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 preliminary results of a Phase 1 open label clinical trial to establish the safety of ST266 when delivered intranasally in Glaucoma Suspect patients. The trial was conducted at the University of Pennsylvania by Ahmara Ross, M.D., Ph.D. and Kenneth Shindler, M.D., Ph.D. of the University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA. ST266 is a novel “secretome”, a cell-free platform biologic containing hundreds of proteins and other growth factors involved in cellular healing and was administered as a targeted nasal spray using the SipNose, Ltd. Cribriform Targeted Device, for which Noveome recently announced a commercial license agreement ( .) The device is able to deliver ST266 to the cribriform plate at the back of the upper nasal cavity where is able to reach the optic nerve, eye and brain, bypassing the blood-brain barrier. Previously published preclinical efficacy and distribution studies laid the groundwork for the Phase 1 clinical trial reported here. The Phase 1 open label clinical trial was designed to assess the safety of intranasally delivered ST266 in Glaucoma Suspect patients diagnosed as having pre-glaucoma conditions that have not yet caused damage to the optic nerve. Dosing occurred in three cohorts. In the first cohort, subjects were intranasally administered ST266 at a dose of two hundred microliters (200 µL) daily for 14 days, in alternating single nostrils. In the second cohort, subjects were intranasally administered 200 µL to each nostril daily (400 µL total per day) for 14 days. In the third cohort, subjects were intranasally administered 200 µL to each nostril daily (400 µL total per day) for 28 days. No drug-related serious adverse events were reported. Preliminary safety assessments, reported here, were performed at baseline and at the end of drug treatment and included visual acuity, slit lamp exam, tonometry, retina exam and ERG, OCT for optic nerve fiber thickness layer, corneal pachymetry, gonioscopy, neuro-cognitive exam, MRI, lumbar puncture, chemistry panel, hematology, and nasopharyngeal exam. All results were normal. Three-, six- and twelve-month safety follow-up visits are planned for all subjects. More information about the study is available at under the identifier NCT03901781. “The preliminary safety results of this Phase 1 clinical trial of intranasally delivered ST266 is an important milestone for Noveome. Now that we have established safety of ST266 by this route of administration, we are actively planning efficacy trials in a variety of neurological and ophthalmological indications,” said Christopher Velis, CEO of Noveome. “We intend to pursue intranasal ST266 in our broad pipeline of indications such as concussion, glaucoma, optic neuritis, and retinal diseases.” About ST266 ST266 is a cell-free biologic containing hundreds of proteins and other factors involved in cellular healing, neuroprotection, and modulation of inflammation. ST266 is produced by collecting proteins and other factors 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. The ST266 platform biologic enables the use of a scalable manufacturing process to produce quantities for all indications, A drug master been submitted with the FDA, supporting all ST266 investigational new drug (IND) applications. About Noveome Biotherapeutics, Inc. Based in Pittsburgh, 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 reported above, Noveome has completed a Phase 2 open-label clinical trial that demonstrated the benefit ST266 had in healing persistent corneal epithelial defects (PEDs). The company has initiated a Phase 1 study evaluating the safety of intravenously administered ST266 in COVID-19 patients and is currently planning a Phase 2 clinical study to further characterize the efficacy and safety of ST266 for the treatment of PEDs. For more information, visit .

PITTSBURGH--(BUSINESS WIRE)-- Noveome Biotherapeutics, Inc., a clinical stage biopharmaceutical company focused on developing next-generation biologics for the restoration of cellular integrity of damaged tissues, has finalized a new Cooperative Research and Development Agreement (CRADA) with Walter Reed Army Institute of Research (WRAIR). The research will test Noveome’s lead product candidate, ST266, in animal models of closed traumatic brain injury (TBI). The TBI models will utilize targeted intranasal nose-to-brain administration of ST266. The ultimate goals are to advance ST266 into human clinical trials of targeted intranasal administration for TBI. The preclinical research will be conducted in the laboratory of Deborah Shear, Ph.D., Branch Chief at WRAIR and is expected to continue for several years leading up to human clinical trials. “We are excited to work with WRAIR on this project, which will build on our previous research using ST266 in a penetrating ballistic brain injury model,” said William Golden, Founder, Chairman and CEO of Noveome. Noveome board member Ronald Poropatich, M.D., M.S. added, “Noveome and WRAIR are committed to developing immediate-use therapies for warfighters who suffer these types of traumatic injuries and this collaboration is vital to achieving that goal.” About WRAIR Around the world, WRAIR works alongside civilian researchers, medical professionals, and military personnel to develop and test products that will ultimately reduce the impact of some of the most dangerous and debilitating diseases. WRAIR provides unique research capabilities and innovative medical solutions to a range of Force Health Protection and Readiness challenges currently facing U.S. Service Members, along with threats anticipated during future operations. 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, 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 as well as the post-COVID-19 symptoms experienced by many COVID-19 patients. Noveome has completed a Phase 2 open-label clinical trial that demonstrated the benefit ST266 had in healing persistent corneal epithelial defects (PEDs). 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 currently planning follow-up clinical studies to characterize the efficacy and safety of ST266 further for the treatment of PEDs and a Phase 1 study evaluating the safety of intravenously administered ST266 in COVID-19 patients. For more information, visit .