The US Food and Drug Administration (FDA) has granted clearance to Bioxytran’s investigational new drug (IND) application enabling initiation of clinical trials of ProLectin-M to treat mild to moderate Covid-19 in standard risk patients.
The oral galectin antagonist ProLectin-M inhibits the SARS-CoV-2 virus entry into human cells.
It achieved an 88% responders rate of negative PCR tests in three days and 100% responders rate by day seven, as demonstrated in earlier clinical studies.
No viral rebounds were observed in the treated population during the 14-day study period.
Bioxytran chief medical officer Dr Leslie Ajayi said: “This clearance of ProLectin-M into the clinic is very important given that this is the first of a number of indications that we intend to pursue to treat large unmet medical needs with our glycovirology technology.
“This is an important milestone for our company, as it represents our first programme to receive FDA clearance to enter the clinic and paves the way for us to pursue other viral indications.
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“The drug was designed by Nuclear Magnetic Resonance Spectroscopy technology to neutralise viruses. Even though we are seeing a resurgence of Covid-19 and its newest variants, BA.2.86 and EG.5, we view our Covid-19 trials as case studies designed to showcase the potential of the galectin antagonist as a broad-spectrum antiviral drug.”
The company is preparing for a Phase III study of Prolectin-M to seek regulatory clearance.
Prolectin-M is designed to antagonise galectins associated with inflammatory, fibrotic, and malignant diseases.
The company’s other programmes under development are intended for treating pulmonary fibrosis and stroke.