RegenxBio. has been granted a patent for a method to treat mucopolysaccharidosis II (MPS II) by delivering recombinant human iduronate-2-sulfatase (IDS) to the central nervous system. The method includes diagnosing MPS II through D2S6 levels in biological samples and calculating specific ratios of disaccharides. GlobalData’s report on RegenxBio gives a 360-degree view of the company including its patenting strategy. Buy the report here.

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According to GlobalData’s company profile on RegenxBio, Adeno-associated virus vectors was a key innovation area identified from patents. RegenxBio's grant share as of June 2024 was 7%. Grant share is based on the ratio of number of grants to total number of patents.

Treatment method for mucopolysaccharidosis ii using iduronate-2-sulfatase

Source: United States Patent and Trademark Office (USPTO). Credit: RegenxBio Inc

The patent US11986515B2 outlines a method for treating mucopolysaccharidosis II (MPS II) in human subjects, focusing on the measurement and analysis of D2S6 levels in biological samples. The method involves obtaining a biological sample, such as cerebrospinal fluid (CSF), from the patient and measuring the D2S6 concentration. A diagnosis of MPS II is made if the D2S6 level exceeds a reference value. Following diagnosis, an effective dose of human iduronate-2-sulfatase (hIDS) is administered to the central nervous system (CNS) using various delivery methods, including adeno-associated virus (AAV) vectors or enzyme replacement therapy. The method also includes calculating the ratio of D2S6 to total heparan sulfate disaccharides to assess treatment responsiveness.

Additionally, the patent describes monitoring D2S6 levels post-treatment to evaluate the effectiveness of the hIDS administration. A decrease in D2S6 levels compared to pre-treatment measurements indicates a positive treatment response. The claims specify various administration routes, including intrathecal and intravenous methods, and outline the potential for treatment in both adult and pediatric populations. The method emphasizes the importance of tracking D2S6 levels over time to confirm therapeutic efficacy, with specific thresholds for acceptable decreases in D2S6 levels post-treatment. Overall, the patent presents a comprehensive approach to diagnosing and treating MPS II, leveraging biomarker analysis to guide therapeutic interventions.

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GlobalData Patent Analytics tracks bibliographic data, legal events data, point in time patent ownerships, and backward and forward citations from global patenting offices. Textual analysis and official patent classifications are used to group patents into key thematic areas and link them to specific companies