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, announced initiation of a Phase 1 open label clinical trial to establish the safety of ST266 when delivered intranasally in patients diagnosed with intraocular hypertension who have not yet developed optic nerve damage.
ST266 is a novel “secretome,” cell-free platform biologic, containing hundreds of proteins and other biological factors involved in cellular healing. For delivery to the optic nerve and brain, ST266 is administered as a nasal spray using the SipNose, Ltd. device and is delivered to the cribriform plate, located at the back of the upper nasal cavity directly to the optic nerve and brain, bypassing the blood-brain barrier.
“The initiation of this Phase 1 clinical trial of intranasally delivered ST266 is an exciting milestone for Noveome as we continue to execute on the vast potential of our cell-free platform biologic in a variety of indications. Based on foundational preclinical results in animal models demonstrating the safety and efficacy of this approach to nerve damage and inflammation, published in Nature Scientific Reports, we believe that ST266 is poised to not only treat the symptoms of optic nerve damage and inflammation, but also the underlying disease,” said William J. Golden, Founder, Chairman and Chief Executive Officer of Noveome.
“We hope to continue to execute across our broad pipeline of indications and develop potential treatments for additional ophthalmologic and central nervous system conditions such as optic neuritis, glaucoma and chronic traumatic encephalopathy.”
“ST266 is a first-of-its-kind platform biologic product that we believe holds great promise in relieving the suffering of patients across a diverse set of diseases and conditions who currently have limited treatment options,” said David L. Steed, M.D., Executive Vice President, Medical Affairs and Chief Medical Officer of Noveome. “Noveome has already treated more than 237 patients with ST266 in nine clinical trials in various indications and in all cases, ST266 demonstrated a strong safety profile with no drug related serious adverse events reported.”
The Phase 1 open label clinical trial is being conducted at the University of Pennsylvania and is designed to assess the safety of intranasally delivered ST266 in patients diagnosed with a pre-glaucoma condition called intraocular hypertension, characterized by a lack of damage to the optic nerve.
Dosing will occur in three cohorts. In the first cohort, subjects will be administered ST266, delivered intranasally, at a dose of two hundred microliters (200 µL) daily for 14 days, in alternating single nostrils. In the second cohort, subjects will be administered 200 µL to each nostril daily (400 µL total per day) for 14 days. In the third cohort, subjects will be administered 200 µL to each nostril daily (400 µL total per day) for 28 days.
ST266 is a cell-free biologic containing hundreds of proteins and other factors involved in cellular healing, protection of the brain and nerves, 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. In addition to ophthalmologic conditions, ST266 is being evaluated in central nervous system (CNS) conditions, pulmonary, gastrointestinal and polytrauma 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.
Source: Company Press Release