Noveome Biotherapeutics said that a Phase 1 safety study of its intranasal ST266 secretome in glaucoma suspect patients demonstrated no serious adverse events at doses up to 400 µL per day over 28 days. The open label study evaluated single doses of 200 µL daily for 14 days, two doses of 200 µL daily for 14 days, and two doses of 200 µL daily for 28 days. Noveome announced the initiation of the study in September 2019.
The ST266 used in the study was delivered via the SipNose Cribiform Targeted Device; Noveome recently announced that it had signed a commercial license agreement with SipNose for use of that device. The company is also working with the Walter Reed Army Institute of Research to conduct preclinical studies of intranasal ST266 for the treatment of traumatic brain injury.
Noveome CEO Christopher Velis commented, “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. We intend to pursue intranasal ST266 in our broad pipeline of indications such as concussion, glaucoma, optic neuritis, and retinal diseases.”
Read the Noveome Biotherapeutics press release.