NovelMed’s strategy to selectively target the Alternative Pathway has led to the development of multiple Best-in-Class antibody Therapies that have shown promising results in a clinical trials. We believe we can lead the rare disease market based on our superior mechanism of action and our efficient development strategy.
Our Phase II proof-of-concept clinical trial is currently ongoing in PNH patients. Our interim results on this dose adjustment trial are very promising. FDA has approved multiple antibodies for multiple indications as listed on the clinicaltrials.gov
Our antibodies selectively block the Alternative Pathway without impacting the Classical Pathway, leading to an expected favorable safety profile without the need for a Black-Box warning. We have strong intellectual property, trade secrets, and expertise that protect our alternative pathway technology.
Our robust pipeline of antibody therapies features two lead candidates, NM5072 and NM8074, both of which have completed Phase I trials in healthy volunteers with no safety concerns. The U.S. FDA has recognized the potential of these therapies by granting them Orphan Drug Designation (ODD) in PNH. NM8074 has demonstrated promising proof-of-concept data in its Phase II trial for paroxysmal nocturnal hemoglobinuria (PNH). Our Antibody Therapies have and addressable rare disease market estimated at over $400 billion.
With a unique portfolio of neutralizing monoclonal antibodies, we are committed to treating rare diseases driven by Alternative Pathway dysregulation. We have pioneered the development of selective Alternative Pathway blockers, currently advancing through clinical trials. This targeted approach reduces side effects while preserving the body's defense against infections. Backed by strong intellectual property and promising Phase II results, NovelMed is set to capture the rare-disease market. In addition to our lead candidates, we have several promising antibodies in preclinical stages, further solidifying our position in the complement space. NovelMed is on track to develop game-changing therapies for patients with unmet needs, with our success in preclinical, pharmacological, toxicological, and clinical studies demonstrating the quality of our lead candidates.
