The United States Food and Drug Administration (FDA) has awarded orphan drug designation (ODD) to NM5072 for the treatment of anemia in PNH patients.The ODD provides NM5072 with a range of benefits,...
FDA grants orphan drug designation to Ruxoprubart (NM8074) for the treatment of PNH.Ruxoprubart is an Anti-Bb antibody that selectively blocks the alternative pathway while maintaining the intactness...
The Phase I healthy trial revealed that NM8074 effectively blocked the alternative pathway (AP) and AP-mediated C3b deposition without affecting the classical pathway (CP). Importantly, NM8074 did not...
Phase I Clinical Trial in healthy subjects shows that NM3086 was safe and well tolerated at all doses (0.1 to 20 mg/kg) in six cohorts. Total AP inhibition was achieved through all cohorts and the...
Anti-Properdin Antibody (NM3086) Demonstrates Efficacy in a Primate Model of Wet-AMD and Dry-AMD
Anti-Bb Antibody (NM8074) Receives US FDA Clearance to Start Clinical Trial in Naïve aHUS Patients (Rare Disease)
CLEVELAND, Dec. 12, 2022 /PRNewswire/ -- NovelMed Therapeutics is a clinical-stage biotechnology company focused on developing anti-complement therapies for rare (orphan) diseases. NovelMed announced today that its lead anti-properdin antibody (NM3086) demonstrated top-line results in a rabbit model of Paroxysmal Nocturnal Hemoglobinuria (PNH). PNH is an orphan indication that is currently treated in part with C3 (Empaveli) and C5 (Soliris/Ultomiris) blockers. All three FDA-approved drugs block the entire complement system, resulting in undesirable effects such as persistent infections, anemia, and only partial remission from elevated lactate dehydrogenase (LDH) levels.
NovelMed Therapeutics is a clinical-stage biopharmaceutical company focused on the development of targeted therapies for complement-mediated rare...
NovelMed Therapeutics has reported positive interim data from a Phase I clinical trial of its complement blocker humanised monoclonal anti-Bb antibody, NM8074.