Neurodegenerative treatment company Enterin Inc said on Friday that it plans to conduct Phase 1/2a study of COV-ENT-1 via by inhalation via standard nebulizer in 80 hospitalized patients with COVID-19 infection in ten US sites following US FDA approval.
Under the company's trial, patients 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.
Following establishment of the dosing regimen, the company will develop a powdered, metered-dose, hand-held inhaler to treat patients with acute respiratory conditions including COVID-19. 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).
Inimmune signs research collaboration with Boston Children's Hospital
ResVita Bio receives USD250,000 phase one Small Business Innovation Research grant from NIAID
Phase II Data of Oral Dexpramipexole Published in Eosinophilic Asthma
AllerVie Health Rebrands Southern Allergy & Asthma
Applied BioCode Inks Distribution Agreement with Medline Industries
Vedanta Biosciences Receives Fast Track Designation for VE303
KalVista Pharmaceuticals Presents Data at 13th C1-inhibitor Deficiency & Angioedema Workshop
French Ophthalmology Specialist Horus Pharma Group Launches a Nordic Subsidiary