Bioxytran, Inc. (OTCQB: BIXT) announced today the successful completion of dose optimization for its novel antiviral drug ProLectin-M in a randomized double-blind placebo-controlled trial. This milestone represents a critical step in the clinical development pathway for the company's lead antiviral candidate, with preliminary results expected soon and full data submission planned to the FDA under the company's active Investigational New Drug (IND) application.
The dose optimization trial evaluated multiple ProLectin-M doses against placebo over a 5-day treatment period. The study's primary endpoint focused on achieving undetectable viral load by Day 7, with secondary endpoints including early viral clearance at Days 3 and 5, symptom improvement measured by the WHO Clinical Progression Scale, and comprehensive safety and tolerability assessments.
"This trial brings us closer to realizing ProLectin-M's potential as a first-line antiviral," said Dr. Leslie Ajayi, Bioxytran's Chief Medical Officer. "The consistency of our results, including 100% viral clearance in prior studies, gives us strong confidence as we prepare for additional clinical trials."
Strategic Implications for Viral Disease Treatment
The newly optimized dosing data will inform the design of additional clinical trials targeting multiple viral indications, including COVID-19, Influenza, Respiratory Syncytial Virus (RSV), and Epstein-Barr Virus (EBV). This broad-spectrum approach positions ProLectin-M as a potentially versatile therapeutic option in the antiviral landscape.
The trial builds upon impressive results from previous studies, which demonstrated a 100% responder rate (negative PCR) by Day 7 and an 88% responder rate by Day 3. These findings suggest ProLectin-M may offer rapid viral clearance, a critical factor in limiting disease progression and transmission.
David Platt, CEO of Bioxytran, emphasized the significance of this achievement: "Dose optimization is a critical milestone for our broad-spectrum antiviral platform. With this data, we can strategically advance ProLectin-M toward potential approval and commercialization."
Regulatory Pathway and Next Steps
The company plans to submit the complete data analysis to both the U.S. Food and Drug Administration (FDA) and the Central Drugs Standard Control Organization (CDSCO) of India to support additional pivotal trials. This dual-regulatory approach may accelerate the development timeline and broaden potential market access.
ProLectin-M represents a novel approach to antiviral therapy as a complex carbohydrate therapeutic specifically targeting viral entry mechanisms. This mechanism of action differentiates it from many existing antivirals and may provide advantages in treating upper respiratory viral infections while contributing to pandemic preparedness efforts.
Bioxytran's Diversified Pipeline
Beyond ProLectin-M, Bioxytran is advancing a diversified therapeutic pipeline across three distinct platforms. The company's virology platform is centered around ProLectin-M, while its oncology platform focuses on metastasis inhibition. Additionally, Bioxytran is developing oxygen transport technologies targeting stroke and neurodegeneration.
Notably, the company's pipeline includes BXT-25, a potential stroke therapy that may significantly reduce treatment delays by more than 90%, addressing a critical unmet need in stroke care where time-to-treatment directly impacts patient outcomes.
As Bioxytran completes the data analysis from this dose optimization trial, the company appears well-positioned to advance ProLectin-M through the next stages of clinical development. The consistent efficacy signals observed thus far suggest potential applications across multiple viral diseases, potentially establishing ProLectin-M as an important addition to the antiviral treatment landscape.
