RT Journal Article
SR Electronic
T1 Drug-free nasal spray as a barrier against SARS-CoV-2 infection: safety and efficacy in human nasal airway epithelia
JF bioRxiv
FD Cold Spring Harbor Laboratory
SP 2021.07.12.452021
DO 10.1101/2021.07.12.452021
A1 Fabio Fais
A1 Reda Juskeviciene
A1 Veronica Francardo
A1 Stéphanie Mateos
A1 Samuel Constant
A1 Massimo Borelli
A1 Ilja P. Hohenfeld
A1 Thomas Meyer
YR 2021
UL http://biorxiv.org/content/early/2021/07/12/2021.07.12.452021.abstract
AB Background For SARS-CoV-2 and other respiratory viruses, the nasal epithelium is a key portal for infection. Therefore, the nose is an important target of prophylactic and therapeutic interventions against these viruses. We developed a nasal spray (AM-301, a medical device marketed as Bentrio) to protect against infection by SARS-CoV-2 and potentially other viruses.Aims of the study To test the safety and efficacy of AM-301 against SARS-CoV-2 infection.Methods AM-301 was tested on an in vitro 3D model of primary human nasal airway epithelium. Safety was assessed in assays for tight junction integrity, cytotoxicity and cilia beating frequency. Efficacy against SARS-CoV-2 infection was evaluated in prophylaxis and infection mitigation assays.Results AM-301 did not have any detrimental effect on the nasal epithelium. Prophylactic treatment with AM-301 reduced viral titer significantly vs. controls over 4 days, reaching a maximum reduction of 99%. When treatment with AM-301 was started 24 or 30 h after infection, epithelia that received the formulation had a 12- or 14-fold lower titer than controls.Conclusion AM-301 was found to be safe in vitro, and it significantly decelerated viral titer growth in experimental models of prophylaxis and mitigation. Its physical (non-pharmaceutical) mechanism of action, safety and efficacy pave the way for further investigation of its possible use against a broad spectrum of viruses, allergens and pollutants.Competing Interest StatementThe study was planned, funded and overseen by Altamira Medica (Zug, Switzerland). FF, RJ and IH are employees of Altamira Medica. VF is a consultant for Altamira Medica. SM is an employee of Texcell (Evry, France), external service provider for Altamira Medica. SC is CEO of Epithelix (Geneva, Switzerland), was a provider for Altamira Medica to perform the safety studies and for the supply of MucilAir tissues. MB has no interests to declare. TM is CEO of Altamira Medica and a shareholder of Altamira Medica.