Novartis will present novel Gilenya data, demonstrating the company’s methods for assessing the impact of relapsing multiple sclerosis (RMS) in both patients and physicians, during the 67th Annual Meeting of American Academy of Neurology (AAN) that will take place in Washington, DC between the 18th and the 25th of April, 2015.
The data will demonstrate how the addition of brain shrinkage to an MS disease activity assessment tool called m-Rio can provide a more accurate prediction method of disability progression, a key to guide RMS treatment decisions.
The pooled analysis from two two-year phase III trials called FREEDOMS and FREEDOMS II will confirm the high efficacy of Gilenya in patients with highly-active RMS who had been previously treated, achieving no evidence of disease activity (NEDA4). Gilenya is the only oral disease-modifying therapy (DMT) that impacts the course of relapsing MS (RMS) by looking at four main measures: MRI lesions, relapses, disability progression and brain shrinkage. Reaching NEDA4 is particularly complicated for patients with highly active RMS, who are prone over time to lose more cognitive and physical functions despite treatment.
“Novartis is committed to innovation beyond the research and development of new treatments, to help physicians and patients improve how multiple sclerosis is managed,” said Vasant Narasimhan, Global Head of Development at Novartis Pharmaceuticals in a press release. “These Gilenya data and new methods of assessing the impact of MS have the potential to give physicians a more comprehensive picture of an individual’s disease and allow patients to better understand their MS.”
More results of the trials will be presented in an early development project called ASSESS-MS, which uses a pioneering recording method to measure an individual’s level of disability in a patient-friendly, non-invasive manner. The tool assesses patients’ movements with Microsoft Kinect sensor through machine learning algorithms. The system was developed after a collaboration between MS specialists and Microsoft Research. ASSESS-MS has the potential to change the assessment of disability progression and neurological dysfunction in patients with MS.
Novartis’ MS portfolio to be presented during the AAN will involve three posters on ASSESS-MS; a total of 16 presentations on Gilenya trial analyses and one poster presentation on BAF312, an S1P-modulator that is being studied for secondary progressive MS (SPMS). The company will join other drug developers in presentations at the conference, including Biogen, who will present new clinical data highlighting the efficacy and favorable safety profile of TECFIDERA, which the company says is the most prescribed oral medicine for relapsing MS in the US.