Ena Respiratory has begun a phase 1 clinical trial of its nasal spray for the prevention of COVID-19 and other respiratory viral infections. The study is expected to wrap up in the third quarter.
Australia-based Ena recently raised AU$32 million ($24 million) to fund the clinical development of its nasal spray INNA-051. The product delivers a TLR2/6 agonist to upregulate innate immune responses in airway epithelial cells. If Ena is right, the upregulation will help people to fight off SARS-CoV-2 and other respiratory viral infections.
Ena has now begun the process of showing how INNA-051 performs in humans. The single and multiple ascending dose study is designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of the therapy.
Enrollment is taking place in a suburb of the Australian city of Sydney, which is contending with an outbreak of COVID-19. The Delta variant is driving the outbreak—and Ena is framing its nasal spray as a solution to the problem of an evolving virus.
“Vaccines have been slowing the spread of COVID-19 in a number of countries, but the world remains at risk with the emergence of variants with increased transmissibility, such as the Delta variant, first discovered in India. Being agnostic to specific virus or viral variant is one of the potential key features of INNA-051,” Ena CEO Christophe Demaison said in a statement.
The World Health Organization’s clinical trial registry lists an INNA-051 safety and tolerability study, although the age range covered by the inclusion criteria, 18 to 65 years, is different from that cited by Ena in its press release, 18 to 55 years.
The listing states the study will start out testing a single 20 mg dose of INNA-051 and determine the subsequent doses based on safety data. In the second and third parts of the trial, participants will use the chosen dose four times, spaced either a few days or one week apart. The third part of the study is open to participants aged 65 to 85 years.
Investigators will assess the safety and tolerability of INNA-051 by looking at vital signs, clinical safety laboratory results, electrocardiograms, nasal assessments and other sources of data.