Noveome Biotherapeutics has presented phase 1 data on its nasally delivered glaucoma candidate ST266. The safety and tolerability data tee Noveome up to advance into efficacy clinical trials in a range of neurological and ophthalmological indications.
ST266 consists of proteins and other factors produced by epithelial cells collected from full-term placentas. As the factors are involved in cellular healing, neuroprotection and the modulation of inflammation, Noveome sees opportunities to treat different diseases with formulations delivered by eye drops, topical oral delivery and a nasal spray.
The phase 1 clinical trial evaluated the delivery of ST266 to the eye, via the nose, using the SipNose Cribriform Targeted Device. By getting ST266 to the optic nerve, Noveome aims to open up central nervous system applications of the drug through a nose-to-brain route of administration that bypassess the blood-brain barrier.
In the study, nine patients with glaucoma suspect received one of three regimens of ST266. The trial began by administering 200 µL a day for 14 days before going on to ramp up to 400 µL for 28 days in the third and final cohort.
No drug-related serious adverse events were reported. Noveome said assessments of visual acuity, optic nerve fiber thickness layer, hematology and other variables at baseline and after the end of the treatment period generated normal results. The results position Noveome to expand its clinical trial program.
“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. We intend to pursue intranasal ST266 in our broad pipeline of indications such as concussion, glaucoma, optic neuritis, and retinal diseases,” Noveome CEO Christopher Velis said in a statement.
Noveome shared the top-line results days after disclosing a commercial license agreement for the SipNose device used to administer ST266. The agreement covers the use of the device to deliver ST266 for the treatment of ophthalmological and brain-related conditions. Noveome has agreed the terms of a supply agreement it expects to finalize before entering phase 3.