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SOHO 2026 | Restore-PV trial: Phase II study of DISC-3405 in polycythemia vera
Naveen Pemmaraju, MD, The University of Texas MD Anderson Cancer Center, Houston, TX, discusses the Restore-PV trial (NCT06985147), a Phase II study evaluating the safety and efficacy of the anti-TMPRSS6 monoclonal antibody DISC-3405 in participants with polycythemia vera. The study showed encouraging clinical activity, with most patients experiencing a reduction or elimination of their need for phlebotomy, supporting further investigation of this approach. This interview took place at the 14th Annual Meeting of the Society of Hematologic Oncology (SOHO 2026) in Houston, TX.
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Transcript
I’m really excited to be here at the SOHO Annual Meeting 2022 in Houston, Texas, where I was able to present on behalf of my colleagues, Dr Naseema Gangat, Mayo Clinic and others, on a very promising new drug in investigational trials called DISC-3405, this is the Restore-PV study. So by way of background, this is a hepcidin modulator. Hepcidin is the master regulator of iron in the body. And so in patients with polycythemia vera those distribution levels are abnormal...
I’m really excited to be here at the SOHO Annual Meeting 2022 in Houston, Texas, where I was able to present on behalf of my colleagues, Dr Naseema Gangat, Mayo Clinic and others, on a very promising new drug in investigational trials called DISC-3405, this is the Restore-PV study. So by way of background, this is a hepcidin modulator. Hepcidin is the master regulator of iron in the body. And so in patients with polycythemia vera those distribution levels are abnormal. We hypothesize that if we can take drugs that try to make that balance happen that you can make iron go back into the places it’s supposed to go decrease the abnormally high hematocrit, make people not need as many phlebotomies, and then hopefully make them feel better. So with that the first in-class drug was rusfertide just recently FDA approved a few days ago for patients with PV. Therefore kind of providing proof to the concept. Now this next approach is with the DISC-3405, which is actually the first ever monoconal antibbody for patients with PV against a specific enzyme called TMPRSS6. And so just to take the viewers through that the TMPRSS6 blocking hopefully then modulates hepcidin to then reduce hematocrit levels render people not needing phlebotomy and then hopefully improving symptoms. So the poster here at SOHO shows that in brief it’s the first public results for that data just presented and it does show a very encouraging signal in this early study that the vast majority of patients are having clinical benefit decrease or a complete elimination of their need for phlebotomy. And so this allows us to think if this can go into later stage and more advanced studies.
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