Re­searchers from the Uni­ver­si­ty of Penn­syl­va­nia have be­gun a small clin­i­cal tri­al to test whether a cin­na­mon-fla­vored gum (no, not Wrigley’s Big Red) could re­duce the amount of Covid-19 in sali­va — a po­ten­tial way to cut trans­mis­sion of the virus.

The gum, de­signed by Penn School of Den­tal Med­i­cine’s Hen­ry Daniell, is made from let­tuce plant cells that were al­tered to ex­press ACE2 — the re­cep­tor that the Covid-19 virus binds to in the body — which en­ables the gum to trap Covid-19 vi­ral par­ti­cles.

In Ju­ly, Daniell and col­leagues pub­lished a pa­per de­scrib­ing the de­sign of their virus-trap­ping gums for var­i­ous strains of Covid as well as the flu. But this isn’t the first gum they’ve made.

Daniell’s lab has long stud­ied the oral de­liv­ery of plant-based drugs, but in re­cent years has al­so been look­ing at plant-based oral drugs for the mouth it­self. Pre­vi­ous­ly, they cre­at­ed a chew­ing gum that con­tained en­zymes that could break down plaque buildup on teeth, Daniell told End­points News, an al­ter­na­tive to get­ting it painstak­ing­ly scraped off by your den­tist. “And then came the pan­dem­ic,” Daniell said.

So they piv­ot­ed to make a virus-trap­ping gum.

In an ear­li­er pa­per, Daniell and col­leagues showed that their ACE2 chew­ing gum could sub­stan­tial­ly re­duce Covid-19 virus count in sali­va sam­ples — a re­sult they repli­cat­ed with var­i­ous strains of the Covid virus and two strains of the flu virus in the Ju­ly pa­per. To move their prod­uct for­ward, they got an IND in May to test the gum in peo­ple and be­gan the clin­i­cal tri­al this month, as first re­port­ed in Penn To­day.

The Phase I/II tri­al will en­roll 40 em­ploy­ees from Penn who have Covid-19, but aren’t get­ting any an­tivi­rals or hos­pi­tal care for it. The em­ploy­ees will have to chew the gum for 10 min­utes four times every day for three days, and col­lect mul­ti­ple sali­va sam­ples over the course of their tri­al pe­ri­od.

The goal of the study is to (1) test the safe­ty of the gum, as with all ear­ly-stage tri­als, and (2) see whether it can ac­tu­al­ly re­duce the vi­ral load in the sali­va of the par­tic­i­pants.

The study is set to fin­ish ear­ly next year, ac­cord­ing to clin­i­cal­tri­als.gov.

“Even though our en­tire tri­al is done with Covid-19 pa­tients, the gum is re­al­ly not in­tend­ed for peo­ple af­ter in­fec­tion. And this is be­cause no­body knows when they get in­fect­ed, so this will be launched as a pro­phy­lax­is prod­uct,” Daniell said, mean­ing that it would be used to pre­vent dis­ease.

The Covid-19 chew­ing gum could pro­vide an af­ford­able al­ter­na­tive in ar­eas where the vac­cine isn’t read­i­ly avail­able, and it could al­so pro­tect health­care work­ers while they per­form oral or den­tal care on un­masked pa­tients, the re­searchers sug­gest in the Ju­ly pa­per.

The the­o­ry be­hind the gum is that cut­ting the amount of virus in sali­va damp­ens the risk of Covid-19 trans­mis­sion and vi­ral load. Covid-19 is trans­mit­ted through flu­ids from the mouth, nose, and eyes, and stud­ies have sug­gest­ed that the sali­va con­tains es­pe­cial­ly high vi­ral loads. But what hap­pens once you spit out the gum? Does the ef­fect last?

That’s an­oth­er thing the re­searchers want to find out from the tri­al. “It is not known how long it takes for a pa­tient to re­build the virus in their mouth and in their sali­va — in spite of hun­dreds of thou­sands of pub­li­ca­tions, no­body has tried it,” Daniell said, though the cur­rent pro­jec­tion his team is run­ning with is four hours.

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.

President Joe Biden yesterday signed into law a bill requiring the Office of the Director of National Intelligence to declassify information on the origins of Covid-19 within 90 days.

The new law directs the federal government to “declassify any and all information relating to potential links between the Wuhan Institute of Virology and the origin of the Coronavirus Disease 2019”, including information regarding researchers at the lab who fell ill in the fall of 2019 like names, symptoms, and job roles.