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Dr. Subramanian: 
It’s an exciting time for thyroid eye disease research. There are several agents in the pipeline with active clinical trials. So what are those trials and how can patients join?

This is CME on ReachMD, and I’m Dr. Prem Subramanian.

We’ve seen success with teprotumumab in addressing the underlying pathology of TED. Teprotumumab is an IGF-1 receptor antagonist and so now there are there other IGF-1 receptor-blocking agents in development. Teprotumumab itself is being studied in a subcutaneous formulation for which clinical trials are about to get underway. Recently completed was a clinical trial, phase 3, of VRDN-001, an IV infusion for active TED patients, and the results of that should be available soon. VRDN-003 is an IGF-1 receptor antagonist that has an FcRn modification to prolong its half-life. And so it is being studied as a self-administered, subcutaneous injection for patients with chronic TED, and a phase 3 trial should soon be underway for that drug.

Lonigutumab, another high-affinity IGF-1R binding agent, is being studied for TED, and a phase 3 study is underway of a subcutaneous formulation, again, to treat patients with more active or shorter-duration TED. And finally, linsitinib, a small molecule inhibitor of IGF-1 receptor activity, an oral agent, it is being studied in a phase 2b trial with future studies potentially being planned.

Now, switching gears, there are other mediators of TED including interleukin-6 or IL-6. And this inflammatory cytokine is involved intimately in the pathogenesis of TED. And IL-6 inhibition through its receptor antagonism by satralizumab, is currently being studied. Satralizumab is FDA-approved for the treatment of neuromyelitis optica spectrum disorder and, currently, as a subcutaneous agent, it is being studied in the SatraGO-1 and -2 trials, phase 3 studies of patients with TED. IL-6 itself is being targeted by the agent TOUR006, and in the SPIRITed dosing study, high/low doses of this subcutaneously given drug are being studied for their efficacy in patients with a more inflammatory, shorter-duration TED.

Now then, finally, I mentioned the neonatal FcRn receptor before, which is a process by which cells use antibody recycling. In other words, when FcRn is targeted within the cells and an antibody is internalized, that antibody can be recycled. So if the FcRn is blocked, then the antibody is more likely to be degraded. So FcRn inhibition is a strategy to get rid of autoantibodies. There are 2 FcRn inhibitors currently being studied. Batoclimab, in the GO-1 and GO-2 phase 3 studies as a subcutaneous infusion, is being studied, and efgartigimod, a drug that is FDA-approved for the treatment of myasthenia gravis, is now being studied in a phase 3 clinical trial called UplighTED.

Links to all of these studies can be found at the NIH website ClinicalTrials.gov. Patients also can find out more information through online patient support and education groups, and there are third-party sites, like Leapcure, that are recruiting patients for clinical trials. You can look in your area to see what practices or institution may be recruiting patients. I encourage you to go to this activity website and look under the related section to find a list of clinical trials that are currently active.

I look forward to having you refer your patients for potential enrollment and I thank you for your joining me today for this CME on ReachMD.

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