We continue our report of interesting developments from the American Academy of Neurology meeting:
Neuromyelytis Optica Spectrum Disorder (NMOSD)
Interest in a rare disease called neuromyelytis optica spectrum disorder (NMOSD) appears to be growing. NMOSD is an autoimmune condition that causes swelling of the optic nerve and spinal cord, which can result in blindness or paralysis. No therapies are approved for the condition, but patients often receive off-label immunosuppressants or steroids. Several companies are developing potential treatments for NMOSD and presented data at AAN, including the AstraZeneca spin-out Viela Bio, Alexion, and Roche/Chugai. Each of their NMOSD contenders work differently: Viela Bio’s inebilizumab is an anti-CD19 antibody designed to deplete B cells, Alexion’s Soliris inhibits complement C5, and Roche/Chugai’s satralizumab is an antibody against IL-6.
Alexion’s Soliris is poised to be the first to reach the market, with an FDA decision expected by June 28, followed by Viela Bio’s inebilizumab, for which a BLA filing is expected mid-year. Alexion has been developing Soliris primarily as an add-on therapy to immunosuppressants, and has achieved a 94% reduction in NMOSD attack risk. In contrast, Viela Bio is developing inebilizumab as a monotherapy, and has achieved a 73% reduction in attack risk. However, it is difficult to compare the trial results for the two treatments, given that Soliris was mostly given to patients already receiving immunosuppressants to reduce their attacks, and Viela Bio focused on a slightly less severe patient population at baseline. Viela’s therapy has the advantage of being more convenient, as inebilizumab is administered via a 90-minute infusion once monthly, while Soliris is given every two weeks via infusion.
But even with potentially comparable efficacy and greater convenience, will Viela Bio be able to overcome Alexion’s lead in this indication? And how will Roche/Chugai’s satralizumab fit in the future landscape given that it is well-behind the two leaders?
Other AAN News
- Roche/Ionis’ antisense approach in Huntington’s disease demonstrated selective reduction in the levels of the mutant huntingtin protein. Based on these results, the companies are now pursuing less frequent dosing schedules, which will substantially decrease treatment-related adverse events.
- GW Pharma announced positive results in tuberous sclerosis complex (TSC) seizures, a rare and severe form of childhood epilepsy, representing the fifth positive phase 3 study for their cannabidiol drug. The company plans to file a Supplemental New Drug Application for this indication in the 4th quarter of 2019. Epidiolex, which was launched at the end of 2018 as the first approved cannabidiol, is already beating Wall Street’s sales expectations. In the first quarter, the company posted $33.5 million in U.S. net sales, compared to consensus expectations of $16 million.