Bioxytran said positive top-line safety and efficacy results from the company’s randomized, placebo-controlled Phase 2 clinical trial of its drug candidate Prolectin-M in 34 patients with mild-to-moderate COVID-19 have been featured in the peer-reviewed journal “Vaccines.”
The company said in a statement that during the trial, an orally administered Galectin Antagonist in the form of a chewable tablet was administered for seven days.
The endpoint was a statistically significant reduction in viral load measured by the number of patients reaching a below-threshold PCR value by day seven, Bioxytran said.
The company reported that most of the symptoms completely disappeared in the group receiving the drug whereas the placebo group had 41.18% of patients that continued to experience chills, 29.41% that had a feverish sensation, and 35.29% that had a cough on day seven.
There was a 100% response rate by day seven versus 6% for the placebo, and an 82% responder rate by day three, which the company said was statistically significant.
Further, there were no drug-related serious adverse events in the patient population or viral rebounds by day 14.
Potential role in treating future pandemics
The positive data from this clinical trial provided the rationale of dosing and protocol design for study in an upcoming Phase 2/3 registrational trial, Bioxytran said.
“After considering all the clinical data and tests it is clear that ProLectin-M could play a major role in treating future pandemics,” commented Dr Alben Sigamani, a member of Bioxytran’s Medical Advisory Board.
“The drug dramatically reduced the viral load which in turn shuts down the transmission of the virus.”
Dr Sigamani noted that 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.
He added that 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,” Dr Sigamani said. “This is why we are looking forward to starting our dosage optimization study which will inform our Phase 3 study and future trial designs.”
The journal article can be found here.
Bioxytran is a clinical-stage biotechnology company developing novel therapies targeting the treatment of significant unmet medical needs in virology, degenerative disease, and hypoxia. Its leading drug candidate, Prolectin-M, is a new class of antiviral drug designed to antagonize galectins implicated in inflammatory, fibrotic, and malignant diseases.
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