How Nipocalimab Targets Unmet Needs in Autoimmune Care

To conclude our discussion with Katie Abouzahr, MD, vice president, Autoantibody Diseases, and Maternal-Fetal Immunology Disease Area Leader, Johnson & Johnson Innovative Medicine, we learn of nipocalimab’s potential associated risks and how the neonatal Fc receptor blocker addresses treatment gaps for patients living with generalized myasthenia gravis.

You can also revisit these earlier interview segments:

Part 1: Understanding gMG: Autoantibodies and Life-Altering Muscle Weakness

Part 2: How FcRn Blockade Targets Myasthenia Gravis Autoantibodies

Part 3: Nipocalimab’s Promising Potential in Advancing gMG Care

This transcript has been lightly edited; captions were auto-generated.

Transcript

What potential risks and adverse effects are associated with nipocalimab?

In the Vivacity phase 3 study [NCT04951622], nipocalimab safety and tolerability were consistent with our other nipocalimab studies. And we saw in the phase 3 registrational study of nipocalimab in generalized myasthenia gravis that the overall incidence of adverse events, serious adverse events, and adverse events leading to discontinuation were similar to that in the placebo-plus-standard-of-care group. So we are excited about what this means for patients in terms of benefit-risk in this disease.

What treatment gaps currently exist for adult patients, and how might this approval them?

Potentially if approved, we think that we're looking at addressing some of the unmet need in this space. It's essentially our guiding principle as to how we think about what diseases we go into and how we design our studies. I think some areas that are really important to patients are, as I mentioned, being able to have sustained, predictable, uninterrupted disease control. That's why we designed the Vivacity study with a primary end point week 22 to 24, so through looking at 6 months of sustained efficacy that's uninterrupted. We think that's an area of unmet need, and we think it's really important to patients.

The other area that we think is sort of an area of unmet need is being able to potentially offer treatment to patients in a broad population—so broad antibody-positive patients, AChR [acetylcholine receptor], MuSK [muscle specific kinase], LRP4 [lipoprotein receptor–related protein 4]—and then, of course, we have also shared data in the adolescent population, 12 to 17 years old. Again, I think that's an area of unmet need where we're looking for approvals of some advanced therapies in this space and where we have publicly shared some of our data in that population.

We go where the actionable science is, where the unmet need is. Nipocalimab is actually being developed across 3 segments of autoantibody-driven diseases. So we've talked about myasthenia gravis, which is a sort of directly autoantibody-driven rare disease. And in that segment, we're so excited about data in generalized myasthenia gravis.

We're excited about the maternal-fetal segment of development for nipocalimab. As I mentioned earlier, one of the mechanisms of action of FcRn blockade with nipocalimab is that it prevents passage of IgG [immunoglobulin G], including in some of these alloimmune diseases of pregnancy, pathogenic IgG from mom to baby. We were so excited to receive breakthrough designation for our phase 2 data in hemolytic disease of the fetus and newborn.

And then the third segment is in the rheumatic space where, again, we're really excited to have been the only therapy to receive breakthrough designation for our phase 2 data in Sjogren disease and where we're excited to have gone forward with a phase 3 program based on robust phase 2 data.