So MINT was a Phase III clinical trial, placebo controlled, that evaluated the safety and efficacy of inebilizumab in patients with generalized myasthenia gravis. The objective of MINT was to evaluate a B-cell depleting therapy strategy focused on anti-CD19 B-cell directed depletion in patients with both acetylcholine receptor or folks with muscle-specific kinase autoantibodies in their condition...
So MINT was a Phase III clinical trial, placebo controlled, that evaluated the safety and efficacy of inebilizumab in patients with generalized myasthenia gravis. The objective of MINT was to evaluate a B-cell depleting therapy strategy focused on anti-CD19 B-cell directed depletion in patients with both acetylcholine receptor or folks with muscle-specific kinase autoantibodies in their condition. Well, this was a Phase III clinical trial that enrolled patients one-to-one placebo versus treatment arm to evaluate folks whether or not they had an improvement in their myasthenia gravis activities of daily living through week 26. We also looked at some additional secondary outcome measures such as the quantitative myasthenia gravis score and some other outcome measures looking at the ability for patients to achieve a three or more point improvement in those scores during the initial randomized control trial period. Our primary endpoint, which was looking at a mean change in MGADL score at week 26 as compared to baseline was achieved demonstrating that patients that received inebilizumab were more likely to have a reduction in their activities of daily living as compared to those that did not receive inebilizumab at week 26. So based on our study findings we show that inebilizumab is an effective treatment that benefits patients with either acetylcholine receptor or muscle specific kinase generalized myasthenia gravis. So some of our next steps are certainly to look at longer-term outcomes. So we also are presenting at this year’s AAN data through 52 weeks in the acetylcholine receptor autoantibody population and our initial findings demonstrate also that patients in the ACHR group are demonstrating a significant reduction in their MGADL score as compared to the placebo group, which is very exciting. In fact, what we’ve also observed as the magnitude of response, if we compare it from week 26 to week 52, was greater at the week 52 time point. So not only was there benefit observed at week 26 in the combined population, which included both acetylcholine receptor and muscle-specific kinase patients, but we’re also seeing greater improvements as time goes, and our data is through 52 weeks at this point, but that’s very encouraging and, again, reinforces the idea that anti-CD19 B-cell depletion therapy is potentially effective and beneficial for patients with generalized myasthenia gravis. It also offers us a new mechanism of action as compared to the currently available treatments that we have for myasthenia gravis that target the upstream immunopathology of the disease. The way that I see B cells is that they are the factories of antibody production so inebilizumab effectively targets antibody secreting cells which are typically plasma blast and plasma cells and that’s what we’re achieving by the use of inebilizumab in patients with generalized myasthenia gravis. So really exciting and encouraging results from our MINT data that we have to date, both at week 26 and also at week 52. So really more to come as we dive deeper into some of the secondary and additional analysis plans at this point. So an initial unique aspect of MINT is that it included a protocol-specified steroid taper in that patients after week 4, at week 4, through week 24 were tapered down on their prednisone dose. So not only do we have a significant improvement in symptoms based on the MG-ADL score, but we also have the ability to reduce corticosteroids over time. And I think that’s really unique and a differentiator from the terms of the clinical trial design for MINT compared to some of the other trials that we have. So again, not only do we have an ability to see a clinical benefit in patients that were treated with inebilizumab, but also a reduced burden of steroids during the randomized control period were also observed during the trial. What’s also unique about inebilizumab is that it’s a medication that’s given twice a year, so every six months. And we also have an open-label extension for MINT that is planned to go for up to three years. So additional information about the durability of response is expected from those additional follow-up time points, and also additional information about the safety and tolerability of inebilizumab in the generalized myasthenic gravis population over time is expected from those results. So more to come, as I noted earlier, about MINT and the role of inebilizumab in the treatment of patients with both acetylcholine receptor and MUSK antibody-positive generalized myasthenia gravis.
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