On August 10, 2026 Silence Therapeutics plc (Nasdaq: SLN), a global clinical-stage biotechnology company developing novel siRNA (short interfering RNA) therapies, reported positive topline results from the Phase 2 SANRECO trial of divesiran, a first-in-class siRNA, in 48 phlebotomy-dependent patients with polycythemia vera (PV).

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The 36-week, randomized, double-blind, placebo-controlled portion of the Phase 2 trial evaluating divesiran (6 mg/kg) administered subcutaneously (s.c.) every six weeks (Q6W) or every twelve weeks (Q12W) met its primary endpoint and secondary endpoints.

Key findings from the study include:

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The primary endpoint was met, with a significantly higher proportion of clinical responders among divesiran-treated patients with PV compared to those who received placebo (88% for divesiran versus 19% for placebo; p<0.0001). The primary endpoint was the proportion of patients achieving a response, which was defined as the absence of phlebotomy and maintenance of hematocrit (HCT) below 45% during weeks 18-36.

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Importantly, both divesiran dose groups showed substantial primary endpoint efficacy with response rates of 93.8% and 81.3% for Q6W and Q12W, respectively.

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The key secondary endpoint of phlebotomy rate during weeks 0-36 was also met with the mean number of phlebotomies per patient in the divesiran groups significantly reduced compared to placebo (0.2 for divesiran versus 2.1 for placebo; p<0.0001).

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Divesiran groups also showed improvements in hematocrit control, iron markers including ferritin, and patient reported outcomes using the MPN-SAF Total Symptom Score (MPN-SAF TSS).

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Divesiran was observed to be well tolerated and safety was in line with previous trials. No new safety findings were observed in the trial. Injection site reactions were infrequent and self-limiting. There were two investigator reported grade 1 anemia adverse event cases.

"Across the SANRECO Phase 1/2 program, divesiran has been well tolerated and has consistently delivered durable hematocrit control in phlebotomy-dependent patients with PV, regardless of risk level or disease severity," said Marina Kremyanskaya, MD, PhD, Associate Professor of Medicine, Hematology and Medical Oncology, at the Icahn School of Medicine at Mount Sinai. "These compelling results highlight divesiran’s potential to transform PV management with convenient, infrequent dosing that reliably controls hematocrit and addresses longstanding unmet needs for patients."

"The SANRECO Phase 2 trial delivered our best-case outcome, confirming the impressive results observed in Phase 1 with dosing every six weeks and demonstrating equally robust and durable effects with quarterly dosing," said Curtis Rambaran, MD, Chief Medical Officer at Silence. "These results reinforce divesiran’s potential to become the first and best-in-class siRNA treatment for PV. We look forward to initiating Phase 3 development and bringing divesiran to patients as quickly as possible."

Silence plans to present full results from the Phase 2 SANRECO trial at an upcoming medical congress.

Silence will host a conference call and webcast today, Monday, August 10, 2026 at 8:00 a.m. ET, to discuss the Phase 2 SANRECO topline results.

Investor Conference Call and Webcast Details

Conference call link: View Source

Webcast link: View Source

A replay of the webcast will be available on the Investors section of the Silence website at www.silence-therapeutics.com/events.

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/kg administered s.c. Q6W or Q12W in patients with uncontrolled hematocrit who are phlebotomy dependent despite standard of care treatment which could include hydroxyurea, interferon and/or ruxolitinib. The primary endpoint of the study was the proportion of patients achieving a response during weeks 18-36, which was defined as the absence of "phlebotomy eligibility." To meet phlebotomy eligibility, patients in the study were required to have hematocrit below 45%. All patients have completed their participation in the placebo-controlled portion of the trial and are now in 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 has FDA Fast Track and Orphan Drug designations for PV.

(Press release, Silence Therapeutics, AUG 10, 2026, View Source [SID1234669906])