Noveome Biotherapeutics 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, MD, PhD, and Kenneth Shindler, MD, PhD, of the University of Pennsylvania, Perelman School of Medicine, Philadelphia.
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. Cribriform Targeted Device, for which Noveome recently announced a commercial license agreement (http://ow.ly/TqOj50EZYyy.) 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-, 6- and 12-month safety follow-up visits are planned for all subjects. More information about the study is available at www.clinicaltrials.gov 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.”
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 file has been submitted with the FDA, supporting all ST266 investigational new drug (IND) applications.