Silence Therapeutics Highlights Follow-Up Data at EHA 2026 Demonstrating Durable Efficacy and Potential Best-in-Class Profile for Divesiran in Polycythemia Vera
LONDON--( BUSINESS WIRE)--Silence Therapeutics plc (Nasdaq: SLN), a global clinical-stage biotechnology company developing novel siRNA (short interfering RNA) therapies, today presented follow-up and quality-of-life data from the Phase 1 SANRECO study evaluating divesiran, a first-in-class siRNA therapy targeting TMPRSS6, in 21 phlebotomy-dependent patients with polycythemia vera (PV) at the European Hematology Association (EHA) 2026 Annual Congress.
Divesiran data presented at EHA show improvements in PV-related symptoms and quality-of-life, complementing the substantial reductions in phlebotomy use as previously reported. Additional analyses also showed substantial reductions in phlebotomy use persisted well beyond the final dose.
“Data presented at EHA continue to reinforce divesiran’s potential to transform the treatment paradigm for patients with polycythemia vera,” said Curtis Rambaran, MD, Chief Medical Officer at Silence Therapeutics. “In Phase 1, we observed sustained hematocrit control, symptom improvement, and robust and durable reductions in phlebotomy burden, which persisted after the final dose. These findings further support the potential for less frequent dosing, including the Q12W regimen being evaluated in our ongoing Phase 2 SANRECO study, and we look forward to reporting topline results in August 2026.”
Key EHA 2026 Data Highlights
The 2026 EHA poster presentation is linked here.
The ongoing Phase 2 SANRECO study (NCT05499013) is evaluating divesiran using Q6W and Q12W dosing regimens in patients with PV. Topline data are expected in August 2026.
SANRECO Phase 1 Study Design
The Phase 1 portion of SANRECO was a 34-week, open-label study evaluating divesiran (3 mg/kg, 6 mg/kg and 9 mg/kg) administered subcutaneously (s.c.) Q6W for four doses, with a 16-week follow-up period following the date of the last administered dose in 21 PV patients. Key inclusion criteria included a PV diagnosis and a history of requiring at least three phlebotomies in the last six months or five in the last year prior to screening. Patients were allowed to be on stable doses of cytoreductive agents. Given the exploratory nature of this Phase 1 study, both well-controlled patients - defined as those with HCT levels ≤ 45% – as well as those with HCT levels > 45% at baseline on current standard-of-care treatment were enrolled.
SANRECO Phase 2 Study Design
The Phase 2 portion of SANRECO is an ongoing, three-part, global, randomized, placebo-controlled, double-blind study evaluating divesiran in 48 phlebotomy-dependent PV patients. The trial is evaluating the safety and efficacy of divesiran 6 mg administered s.c. Q6W or Q12W in patients with uncontrolled HCT who are phlebotomy-dependent despite standard-of-care treatment which could include hydroxyurea, interferon and/or ruxolitinib. The primary endpoint of the study is the proportion of patients achieving a response during weeks 18-36, which is defined as the absence of “phlebotomy eligibility.” To meet phlebotomy eligibility, patients in the study are required to have HCT ≥ 45%. Following the placebo-controlled portion of the trial, patients enter the 3-year, double-blind and open label extension periods.
About PV
PV is a rare, myeloproliferative neoplasm – a type of blood cancer - characterized by the excessive production of red blood cells, often resulting in elevated hematocrit levels. Elevated hematocrit above 45-percent is associated with a four-times higher rate of death from cardiovascular and thrombotic events. PV is associated with a range of burdensome symptoms including fatigue, cognitive disturbance and pruritus and additionally, longer term can transform to myelofibrosis and Acute Myeloid Leukemia. The aim of treatment is to maintain hematocrit less than 45%, a level that is associated with a reduced incidence of thrombosis and CV-associated death. The current standard of care includes repeated phlebotomies to reduce hematocrit and/or cytoreductive agents to reduce red blood cell production. There are currently no approved therapies that specifically target red blood cells and hematocrit.
About Divesiran
Divesiran is Silence’s wholly owned siRNA product candidate developed from its proprietary mRNAi GOLD™ platform that “silences” TMPRSS6 expressed almost exclusively in the liver. TMPRSS6 is a negative regulator of hepcidin, the body's master regulator of iron metabolism including its absorption, distribution, and storage. By silencing TMPRSS6 in PV patients, divesiran aims to increase hepcidin production and release by liver hepatocytes, leading to the restriction of iron to the bone marrow and, thus, reducing the excessive production of red blood cells, a process dependent on availability of iron. Divesiran is currently in Phase 2 development for PV and has FDA Fast Track and Orphan Drug designations for PV.
About Silence Therapeutics
Silence Therapeutics is a global clinical-stage biotechnology company committed to transforming people’s lives by silencing diseases through precision engineered medicines created with proprietary siRNA (short interfering RNA) technology. Silence leverages its mRNAi GOLD™ platform to create innovative siRNAs designed to precisely target and silence disease-associated genes in the liver, which represents a substantial opportunity. Silence focuses on areas of high unmet medical need with programs advancing in cardiovascular disease, hematology and rare diseases. For more information, please visit https://www.silence-therapeutics.com/.
Forward-Looking Statements
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