Noveome Biotherapeutics said that it has initiated a Phase 1 safety trial of its ST266 secretome delivered intranasally in patients with intraocular hypertension. The study will use a device from SipNose designed to deliver drugs across the blood-brain barrier to deliver ST266. Noveome is developing ST266 in several dosage forms, with intranasal ST266 also in development for optic neuritis, glaucoma and traumatic brain injury.
In 2017, Noveome announced pre-clinical data from a study of ST266 in a mouse multiple sclerosis model that showed anti-inflammatory activity and retinal ganglion cell (RGC) retention in the optic nerve. Earlier this year, the company said that it had raised $15 million in Series D financing for further development of ST266.
The Phase 1 open label trial will evaluate three doses of intranasal ST266: 200 µL daily in alternating nostrils for 14 days, 200 µL daily to each nostril daily (400 µL total ) for 14 days, and 400 µL total for 28 days.
Noveome Chairman and CEO William J. Golden commented, “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. 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.”
Executive VP, Medical Affairs and Chief Medical Officer David L. Steed said, “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. 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.”
Read the Noveome Biotherapeutics press release.
