PHILADELPHIA, April 17, 2020 /PRNewswire/ -- Enterin, Inc., a clinical-stage company focused on neurodegenerative diseases, announced today that it has received feedback from the FDA laying out the path for a Phase 1/2a study in hospitalized patients with COVID-19 infection.
The study will involve 10 U.S. sites and will enroll 80 hospitalized patients. Patients will have been diagnosed with SARS-CoV-2, have an SpO2 ≤94% or evidence of pneumonia by chest XR or CT scan. The first stage will involve 24 patients randomized in groups of four to escalating doses of COV-ENT-1 or placebo. The second stage will involve another 56 patients randomized to COV-ENT-1 or placebo at the highest tolerable doses. Patients will be followed for 28 days. The compound is administered by inhalation via standard nebulizer.
Once the dosing regimen has been established, a powdered, metered-dose, hand-held inhaler will be developed to treat patients with acute respiratory conditions including COVID-19 or other respiratory infections on an out-patient basis.
COV-ENT-1 has been shown to have broad-spectrum antiviral activity against both RNA and DNA viruses, both in vitro and in vivo, in studies supported by the National Institutes of Allergy and Infectious Diseases (NIAID). It interferes with virus entry, protein synthesis, replication and egress, essentially rendering the cell resistant to viruses. Additionally, in a recent lab study, it was shown to inhibit the replication of SARS-CoV-2 at low concentrations. COV-ENT-1 has also been shown to stimulate regenerative activity, and it could potentially promote tissue repair in lungs damaged by the SARS-CoV-2 virus.
Assuming Enterin is allowed to proceed with the study, it is anticipated that the study will begin within the next three months.
About Enterin Inc.
Enterin, Inc. is a Philadelphia-based, privately held, clinical-stage CNS company developing compounds for the treatment of neurodegenerative disorders such as Parkinson's disease and Alzheimer's disease. The company is currently conducting a large, randomized, placebo-controlled Phase 2b (KARMET) trial to further explore the effect of ENT-01 on constipation and neurologic symptoms in patients with Parkinson's disease. The details of the study can be found on Clinicaltrials.gov (NCT#03781791). A second compound, ENT-03 is in advanced pre-clinical development for the treatment of Alzheimer's disease.