Summary of Chemomab Therapeutics (CMMB) FY Conference Company Overview - **Company**: Chemomab Therapeutics - **Focus**: Development of novel treatments for inflammatory and fibrotic diseases - **Lead Asset**: First-in-class monoclonal antibody targeting CCL24, involved in inflammation and fibrosis [2][4] Industry Context - **Target Disease**: Primary sclerosing cholangitis (PSC) - **Characteristics**: Significant inflammation and fibrosis in the bile duct, no approved treatments available [3][5] - **Patient Demographics**: Approximately 70,000 patients in major markets, primarily young men around their 40s [6] Clinical Development - **Phase II Study**: Successfully completed with positive results - **Participants**: 76 patients, treated with Nebucadnezar at doses of 10 mg/kg, 20 mg/kg, and placebo [9] - **Endpoints**: Safety, tolerability, and various markers of disease progression [10] - **Results**: - Met primary safety endpoint and secondary endpoints showing anti-inflammatory and anti-fibrotic activity [11] - Identified 20 mg/kg as the effective dose for further studies [11] Efficacy and Safety Data - **Biomarker Improvements**: - Significant reduction in liver stiffness and ELF score, indicating disease progression [12][13] - Dose-dependent improvements in inflammatory markers such as IL-6 and IL-18 [14] - **Long-term Safety**: - 93% of eligible patients continued in open-label extension, showing sustained reduction in biomarkers after 48 weeks [16] - Nebucadnezar remained safe and well-tolerated [16] Competitive Landscape - **Unique Positioning**: - Nebucadnezar is the only drug suggesting disease modification in PSC, unlike competitors focusing on symptom management [6][7] - Potential to become the first approved drug for PSC, addressing a significant unmet medical need [8] Market Opportunity - **Commercial Potential**: - Estimated annual commercial opportunity exceeding $1 billion under conservative assumptions [9] - Premium pricing expected due to first-in-class mechanism and significant unmet need [9] Regulatory Engagement - **FDA Interaction**: - Clear alignment with FDA on a single pivotal study for full approval of Nebucadnezar in PSC [20][21] - Study design will evaluate multiple clinical events beyond just liver transplant and death [21] Future Plans - **Phase III Study**: - Preparations underway to initiate Phase III clinical study as soon as possible [22] - Ongoing discussions with potential partners to facilitate market entry [22] Conclusion - **Transformative Potential**: - Nebucadnezar represents a breakthrough in PSC and potentially other fibrotic diseases, with strong data supporting its efficacy [23] - Chemomab Therapeutics is positioned to lead in addressing this rare disease with significant unmet needs [23]