SIDIPREV™: A New Model for Infectious Disease Investing — Rapid Adoption, Strong Market Value, High Margins, Exceptional ROI.
SIDIPREV™ is designed to solve a $6 billion healthcare problem with no approved preventive solutions available. Hospitals face substantial financial penalties and unreimbursed costs from C. difficile infections. SIDIPREV™ offers cost-efficiency for hospitals — significantly reducing infection-related losses — while maintaining high-margin pricing for LPOXY. With no vaccine hesitancy, no antimicrobial stewardship barriers, and no competing prevention therapies, SIDIPREV™ is uniquely positioned for rapid adoption and scalable market penetration. With successful clinical validation, SIDIPREV™ could become the new standard of care for C. difficile prevention — delivering high clinical impact alongside a capital-efficient, profitable business model.
Market Niche Facts
Market Comparison
Exit Comparison In 2022, GSK acquired Affinivax for $3.1 billion, including milestones, based on their 24-valent pneumococcal vaccine after phase 2. Notably, the pneumococcal vaccine market is highly competitive and fragmented (see above). In contrast, Clostridioides difficile infection (CDI) currently has no approved therapies for the prevention of primary infections. SIDIPREV™ is positioned as a first-in-class preventive therapy, offering a unique opportunity to address this unmet need and setting the stage for a significant exit and strong return on investment.
Efficient Development Pathway SIDIPREV™ is advancing under an LPAD-based pivotal clinical development plan. We are preparing for a pivotal Phase 2 trial designed to meet the FDA’s LPAD criteria for approval in serious, life-threatening infections.
Our targeted regulatory pathway leverages existing safety data and clinical precedence for oxygen therapeutics, significantly reducing development risk and time. We anticipate pivotal trial completion and NDA filing by 2029, positioning the program for a possible strategic acquisition or exit at or before regulatory submission.
Robust Intellectual Property Protection SIDIPREV™ is protected by a portfolio of issued patents extending through 2047 in major global markets, securing long-term exclusivity and market value.
Active Capital Raise: Pivotal Trial Execution LPOXY is raising capital to execute our pivotal Phase 2 clinical trial under FDA’s LPAD pathway — a targeted, capital-efficient route to approval.
We are assembling a consortium of strategic investors to enable trial initiation in 2025 and drive value-creation milestones through NDA filing by 2029.