A recently launched clinical trial at the University of Pennsylvania will evaluate a chewing gum designed by Penn Dental Medicine's Dr. Henry Daniell to trap SARS-CoV-2 in the saliva, potentially blocking transmission of COVID-19 decrease self-infection.
The trial will recruit participants from a pool of Penn Medicine employees whose responses to a screening system indicate that they may be battling COVID-19. Those who enroll will be given a packet of 12 experimental gum tablets, to be chewed four times each day, for three days.
The cinnamon-flavored gum is designed to do far more than freshen breath. Thanks to innovations emerging from Daniell's lab, the gum contains plant-derived material genetically engineered to contain ACE2, a protein found naturally in human blood and saliva. The ACE2 receptor is found on human cells and is bound by SARS-CoV-2 virus during infection. In experimental models, chewing the gum released the embedded ACE2, blocking the interaction of the chewer's own ACE2 receptor and the viral spike protein.
In effect, the gum is designed to trap and neutralize SARS-CoV-2 in the saliva and, ideally, diminish the amount of virus left in the mouth. It is hoped that less virus would mean a lower likelihood of passing the infection on to others or developing symptoms.
Daniell and colleagues are also working on another gum, containing a different protein, which could target a broader range of respiratory viruses, including influenza.
"I'm hoping that if this is effective and safe it will be the beginning of several other oral delivery drugs using this platform," says Daniell, W. D. Miller Professor and Vice Chair of the Department of Basic and Translational Sciences.
Findings from a preclinical study of the gum's efficacy in neutralizing SARS-CoV-2 and influenza virus in patient samples, published in Biomaterials in July, showed it could reduce viral load to nearly undetectable levels. The results supported an application to the U.S. Food and Drug Administration for an Investigational New Drug, which went into effect in May and paved the way for the launch of the clinical trial. The gum represents the first Investigational New Drug submission for a human therapeutic protein drug that does not require a cold chain or protein purification. Read more >>
