Bioxytran, Inc. reported that its Phase 2, randomized, double‑blind, placebo‑controlled study of the oral antiviral ProLectin‑M achieved 100 % viral clearance by day 7 in all 38 enrolled subjects, with a statistically significant p‑value of 0.001.
The trial enrolled 38 patients with laboratory‑confirmed acute viral infection and randomized them to one of three dose levels of ProLectin‑M or placebo. All participants completed the seven‑day treatment period, and viral shedding was measured by RT‑PCR of nasopharyngeal swabs at scheduled time points. The data show that 1 of 38 patients had undetectable viral RNA by day 3, 16 of 38 by day 5, and the remaining 22 reached non‑detection by day 7, resulting in a 100 % clearance rate at the study’s primary endpoint.
CEO Dr. David Platt said the results “confirm the broad‑spectrum antiviral potential of ProLectin‑M and validate our galectin‑antagonist mechanism, which blocks viral entry at the cell surface.” He added that the findings will inform regulatory discussions for late‑stage development and support the company’s strategy to evaluate the candidate across additional viral indications.
The trial’s success echoes a 2022 Phase 2 study in COVID‑19 patients that reported an 88 % response rate by day 3 and 100 % by day 7, underscoring a consistent efficacy signal. Bioxytran’s platform focuses on glycovirology, hypoxia, and degenerative diseases, positioning ProLectin‑M as a potential first‑in‑class therapy for a range of viral pathogens.
With the Phase 2 data in hand, Bioxytran plans to advance ProLectin‑M into larger, confirmatory trials and to engage with regulatory authorities to define the drug’s approval pathway. The company’s next steps include expanding the candidate’s indication portfolio and leveraging its unique mechanism to differentiate itself in the competitive antiviral market.
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