NS Pharma, Inc. (NS Pharma) is excited to announce participation in the 2024 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference in Orlando, Florida, March 3 – 6.
Evidence of meaningful benefit in pulmonary function for patients with PARAMUS, N.J., March 6, 2024 /PRNewswire/ -- NS Pharma, Inc. (NS Pharma) is excited to announce participation in the 2024 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference in Orlando, Florida, March 3 – 6. The company presented a poster entitled “Pulmonary and motor function in ambulatory and non-ambulatory participants with Duchenne muscular dystrophy (Duchenne) treated with viltolarsen (VILTEPSO®)” which covers data from the Galactic53 trial demonstrating that the majority of participants receiving viltolarsen experienced meaningful benefit in pulmonary function, including percent predicted forced vital capacity (FVC%p). “Galactic53 is the first trial with VILTEPSO to evaluate pulmonary function in participants with Duchenne,” explains NS Pharma Vice President Medical Affairs & Pharmacovigilance Leslie Magnus, MD, who also co-authored the poster. “Our team is encouraged by these results and will continue our research into treatments for rare disease.” Galactic53 was a Phase 2, open-label, multicenter study of viltolarsen administered intravenously, 80mg/kg once weekly, in both ambulatory and non-ambulatory individuals with Duchenne who are amenable to exon 53 skipping therapy. The study also found that the upper limb motor function of participants was stabilized over 49 weeks in both ambulatory and non-ambulatory patients. Viltolarsen was well tolerated by participants, and the safety profile was consistent with previous reports. View the poster online: https://www.nspharma.com/events. Additional data from this study will also be presented at the American Academy of Neurology (AAN) 2024 Annual Meeting, April 13 – 18 in Denver, Colorado and online. About VILTEPSO® (Viltolarsen) Injection Indication Important Safety Information Serum cystatin C, urine dipstick, and urine protein-to-creatinine ratio should be measured before starting VILTEPSO. Consider also measuring glomerular filtration rate before starting VILTEPSO. During treatment, monitor urine dipstick every month, and serum cystatin C and urine protein-to-creatinine ratio every three months. Urine should be free of excreted VILTEPSO for monitoring of urine protein. Obtain urine either prior to VILTEPSO infusion, or at least 48 hours after the most recent infusion. Alternatively, use a laboratory test that does not use the reagent pyrogallol red, which has the potential to generate a false positive result due to cross reaction with any VILTEPSO in the urine. If a persistent increase in serum cystatin C or proteinuria is detected, refer to a pediatric nephrologist for further evaluation. Adverse Reactions: The most common adverse reactions include upper respiratory tract infection, injection site reaction, cough, and pyrexia. To report an adverse event, or for general inquiries, please call NS Pharma Medical Information at 1-866-NSPHARM (1-866-677-4276) For more information about VILTEPSO, see full Prescribing Information. About Duchenne Muscular Dystrophy (Duchenne) About NS Pharma, Inc. U.S. Media Contact: View original content to download multimedia:https://www.prnewswire.com/news-releases/ns-pharma-inc-shares-new-viltepso-viltolarsen-data-at-the-mda-clinical--scientific-conference-2024-302080958.html SOURCE NS Pharma, Inc. |