NovelMed’s Phase II Data in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients: Ruxoprubart Shows Best-in-Class Efficacy as Monotherapy--- Ruxoprubart (NM8074) met all clinical endpoints, offering a safe, differentiated treatment for Paroxysmal Nocturnal Hemoglobinuria (PNH).
United States FDA Approves NM8074 (Ruxoprubart) IND for Treating Dermatomyositis (DM): A Chronic Inflammatory Disorder of the Skin--- The United States FDA Approves the Initiation for Phase II Efficacy Trial in Dermatomyositis (DM) Patients: A Skin & Muscle Disorder
FDA Approves Phase II Clinical Trial for Ruxoprubart in ANCA Associated Vasculitis (AAV) – a Chronic Rare Disease in Nephrology-- The United States FDA Clears Initiation of Efficacy Trial in Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis (AAV) Patients
Ruxoprubart (NM8074) Scores FDA Orphan Drug Designation for Paroxysmal Nocturnal Hemoglobinuria (PNH) TreatmentCLEVELAND, Feb. 12, 2024 (GLOBE NEWSWIRE) -- NovelMed today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Ruxoprubart, an alternative pathway (AP) blocker anti-Bb antibody, for the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH). FDA's recognition of Ruxoprubart as an orphan drug for PNH underscores its potential to fulfill a crucial need for individuals grappling with this disease condition.
USAN Approves Generic Name “Ruxoprubart” for NM8074, an Antibody Therapy focused on Complement-Mediated DiseasesCLEVELAND, Ohio, Jan. 08, 2024 (GLOBE NEWSWIRE) -- NovelMed, a clinical-stage biopharmaceutical company with expertise in inflammatory and complement-related diseases, is pleased to announce that the United States Adopted Name (USAN) Council has officially assigned the generic name "Ruxoprubart" to its monoclonal antibody candidate, NM8074. Currently in Phase II trial for Paroxysmal Nocturnal Hemoglobinuria (PNH), a hemolytic disease, Ruxoprubart (NM8074) represents a significant breakthrough.
NovelMed Commences Phase II Trial for Anti-Bb Antibody (NM8074) in Treatment-Naïve PNH Patients: A Glimpse into the PNH Study ProgressCLEVELAND, Oct. 30, 2023 (GLOBE NEWSWIRE) -- NovelMed Therapeutics is excited to announce the commencement of its Phase II clinical trial targeting treatment-naïve Paroxysmal Nocturnal Hemoglobinuria (PNH) patients with its groundbreaking anti-Bb antibody, NM8074. This open-label, multi-dose, and multi-center study aims to assess the safety and efficacy of NM8074 in PNH patient population. To date, eight PNH patients have been enrolled in the trial, with two patients already receiving NM8074 treatment. Key efficacy parameters include increases in Hemoglobin, increase in RBC clone size, decreased Lactate Dehydrogenase (LDH) levels, reduced pRBC transfusions, and reduced D-Dimer levels. Positive outcomes on these measures will pave the way for NM8074 as a highly differentiated and innovative biologic for treatment-naïve PNH patients.
NovelMed Phase I Clinical Trial Shows Inhibition of the Alternative Pathway and Preservation of the Classical Pathway – A Long-Acting Anti-Properdin Monoclonal Antibody NM3086 for PNH PatientsCLEVELAND, June 05, 2023 (GLOBE NEWSWIRE) -- NovelMed Therapeutics, Inc. announced today topline results from First-in-Human Phase I clinical trial of its complement blocker monoclonal anti-Properdin antibody, known as NM3086. The trial was a randomized, double-blind, placebo-controlled, single ascending dose study designed to assess safety and tolerability, pharmacokinetics (PK) and pharmacodynamics (PD), and immunogenicity (ADA) of NM3086 in healthy volunteers.
