Chewable Covid-19 Drug Reduces Viral Load, Symptoms

(Gerd Altmann, Pixabay)

29 Mar. 2023. Clinical trial results show an experimental drug given as a chewable tablet reduces viral load and symptoms in people with mild to moderate Covid-19 disease. Findings from the study, conducted in India and sponsored by the drug developer BioxyTran Inc. appear on 25 March 2023 in the journal Vaccines.

While Covid-19 is disappearing from news headlines, the disease remains prevalent in many parts of the world. For people becoming infected with the SARS-CoV-2 virus responsible for Covid-19, only a few approved treatments are available, as some of the earlier synthetic antibody therapies are not fully effective against new variants of the virus. As a result, physicians and public health authorities need new treatments that reduce the viral load and clear the virus in people with Covid-19 infections from a pathogen that continually mutates.

BioxyTran is a five year-old biotechnology enterprise in Boston developing therapies for diseases associated with the galectin-3 protein that binds to carbohydrates in a number of diseases. The company’s technology is based on research by David Platt, the company’s founder and CEO, to create galectin-3 inhibitors that reduce the protein’s ability to replicate. ProLectin-M, BioxyTrans’s lead product, is a chewable tablet with galectin-3 inhibitors that block the entry of SARS-CoV-2 virus to cells by preventing the binding to glycan carbohydrates on cell surfaces and receptor proteins called lectins. Galectin-3 inhibitors are also shown to reduce inflammatory effects of immune responses associated with Covid-19 disease.

The company says ProLectin-M binds to lectin receptors found in the SARS-CoV-2 original virus and its subsequent variants, rather than the virus’s spike protein targeted by most antibody treatments for Covid-19. Viruses blocked by the drug are then filtered by the liver and eliminated. As a result, says BioxyTran, ProLectin-M offers a more continuing and sustainable Covid-19 therapy. In an early-stage clinical trial in India, the company reports participants with mild to moderate Covid-19 disease cleared their symptoms within 72 hours, and reducing their viral loads to zero within seven days.

Tablets chewed every hour for seven days

The mid-stage clinical trial reported in the paper enrolled 34 participants in India with mild to moderate Covid-19 disease. Participants were randomly assigned to received ProLectin-M chewable tablets or a placebo, taken every waking hour for seven days, with a maximum of 10 tablets per day. Because of ProLectin-M’s affinity for carbohydrates, participants waited until 30 minutes after meals to chew their tablets, to avoid interaction with blood glucose. Participants were predominantly male (71%), with an average age of 42 years for ProLectin-M recipients and 37 for placebo recipients.

Results show ProLectin-M recipients cleared all of their virus compared to six percent reductions in placebo recipients, and exhibited no Covid-19 symptoms after seven days. The authors note that shorter times of infection are associated with lower likelihood of experiencing extended symptom periods, known as “long Covid”. In addition, say the authors, participants exhibit no serious adverse effects from the drug.

“The drug dramatically reduced the viral load which in turn shuts down the transmission of the virus,” says lead author and BioxyTran scientific advisor Alben Sigamani in a company statement. “Recent analysis reveals that reducing the number of days of infectivity can have a dramatic impact on the number of overall infections, hospitalizations, and economic burden. The key to stopping this cycle of immune evasion is to quickly treat the infected and provide prophylaxis to those exposed. The trial results demonstrate we may be able to do both.”

BioxyTran plans a late-stage clinical trial of ProLectin-M that aims to enroll more than 400 participants with Covid-19 infections, including those hospitalized, testing the drug against a placebo.

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