US-based Enterin Inc. announced that it has been in talks with the FDA in preparation for a Phase 1/2a study of a nebulized formulation of its COV-ENT-1 in patients hospitalized with COVID-19. The company said that it plans to develop a dry powder COV-ENT-1 for inhalation if the study is successful. Enterin’s lead candidate, ENT-01 (kenterin), is currently in Phase 2 development as an oral therapy for Parkinson’s disease.
According to Enterin, a study conducted recently showed that COV-ENT-1 inhibited the replication of low levels of SARS-CoV-2 and could possibly promote healing of lung tissue damaged by the virus. The company also said that previous in vitro and in vivo studies backed by the National Institutes of Allergy and Infectious Diseases (NIAID) have demonstrated that COV-ENT-1 interrupts the viral activity of both RNA and DNA viruses.
The first part of the proposed new study would enroll 24 patients diagnosed with pneumonia or oxygen saturation ≤94% due to SARS-CoV-2 infection and would evaluate 4 doses of COV-ENT-1 versus placebo. In the 28-day second part of the study, 56 patients would receive either the highest tolerable dose of COV-ENT-1 via standard nebulizer or placebo, with patients followed for 28 days. If approved by the FDA, the trial would begin within three months, the company said.
Read the Enterin press release.
