SANRECO Trial Explores Divesiran for Polycythemia Vera Treatment

The phase 2 SANRECO study has recently completed enrollment and will evaluate divesiran, a potential therapy for patients with polycythemia vera (PV), a blood cancer characterized by excessive red blood cell production. PV is classified as a myeloproliferative neoplasm (MPN), a type of blood cancer affecting the bone marrow.

This global, randomized, double-blind, placebo-controlled study enrolled 48 patients with PV, with initial topline results expected in the third quarter of 2026. To learn more about the trial, CURE spoke with Dr. Marina Kremyanskaya, the lead investigator of the SANRECO trial, to discuss current standard-of-care options for PV, the objectives of the phase 2 study, the mechanism of divesiran, and more.

Kremyanskaya is an associate professor of Medicine, Hematology and Medical Oncology, at the Icahn School of Medicine at Mount Sinai in New York.

CURE: What is the current standard of care for patients newly diagnosed with PV, and what challenges or limitations exist with these treatments?

Kremyanskaya: There are a few different pathways that we could take. Typically, we look at a patient and determine which risk category they fit into. Somewhat artificially, patients are divided into two groups: low risk and high risk, and this is really based on their risk of thrombosis, meaning blood clots, in the future. It is mostly decided based on their age. At 60 years old, patients are considered high risk, and if they are younger than that, they are considered low risk. An additional risk factor is a previous history of blood clots, so if patients have none of that, they are considered low risk.

The typical treatment is therapeutic phlebotomy. Basically, we physically remove some of the blood from the patient in a process similar to what is done when people donate blood. The reason for this is that blood counts are very high, which puts patients at a higher risk for thrombosis. It has been shown that by decreasing the blood count, specifically the red blood cells, we can reduce their risk of thrombosis. Thrombosis, in this case, can be anything, for example, heart attacks, strokes, or blood clots in the legs, lungs, or other parts of the body. These can have very serious consequences.

Typically, we also have patients take a low-dose aspirin as a mild blood thinner to decrease the risk of blood clots. If patients are higher risk, then in addition to phlebotomies, we have a few other treatment choices. One of them is hydroxyurea, which works to reduce all blood counts. We have been using hydroxyurea for many decades for different blood cancers, and it is still commonly used in PV. Other options include interferon, which comes in a few different formulations and is given as injections, and Jakafi (ruxolitinib), a newer drug that is a JAK inhibitor. Jakafi is more of a biologic therapy that specifically targets the activated pathway seen in these disorders.

While there are a few different choices, phlebotomy remains the cornerstone of treatment. Although it sounds like there are many options, the reality is that there are actually not that many.

What is the primary objective of the SANRECO clinical trial, and how does it aim to address unmet needs in PV management?

What this clinical trial is doing is using the pathway that is important for iron metabolism and control of iron in the body to regulate the number of red blood cells produced. As I mentioned, the major issue for patients with PV is that the bone marrow is inappropriately making too many red blood cells. As a result, the blood becomes very thick, putting patients at risk for all the complications we discussed, as well as many different symptoms (some not mentioned), such as fatigue, difficulty concentrating, itching, and many others. Every patient experiences symptoms slightly differently.

This drug targets the pathway for the hormone hepcidin, which is a regulator of iron metabolism in the body. Iron is very important for red blood cell production. Typically, when iron is limited, red blood cell production decreases. This is why patients become iron deficient and anemic after excessive bleeding. For example, people often say, “I’m anemic. I need to take some iron.” This process is regulated by hepcidin.

We know that patients with PV actually have lower hepcidin levels, which is expected in this condition. By increasing hepcidin levels, the amount of iron available in the bone marrow for red blood cell production is minimized. As a result, the bone marrow produces fewer red blood cells. Instead of requiring phlebotomy to physically remove blood, this approach allows control of how much blood the bone marrow produces, thereby managing hematocrit and hemoglobin levels. It represents a very different approach to the treatment of PV.

Can you provide an update on the current status of the SANRECO trial and what key milestones or results we can expect in the near future?

Phase 2 is ongoing, and excitingly, just finished enrollment, so all the patients are enrolled. Now, we just have to wait for the results of the trial, so it's a very exciting time for this drug.

Transcript has been edited for clarity and conciseness.

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