Silence Therapeutics Unveils Positive Follow-Up Data for Divesiran in Polycythemia Vera at EHA 2026
Durable Efficacy, Symptom Improvement, and Reduced Phlebotomy Burden Signal Best-in-Class Potential; Phase 2 Topline Results Expected August 2026
London, June 11, 2026 – Silence Therapeutics plc (Nasdaq: SLN), a clinical-stage biotech specializing in siRNA therapies, has reported highly encouraging follow-up and quality-of-life data for its lead asset, divesiran, at the European Hematology Association (EHA) 2026 Congress. The new results, stemming from the Phase 1 SANRECO study in polycythemia vera (PV) patients, underscore durable efficacy and pave the way for potentially best-in-class profile as a treatment for PV.
Key Highlights from the EHA 2026 Data
- Durable Reduction in Phlebotomy Use: In the 6 months prior to treatment, 21 enrolled PV patients required 80 phlebotomies. During active treatment with divesiran, only 5 phlebotomies were required (all in patients with poorly controlled hematocrit at baseline). In the 16-week follow-up after the final dose, just 4 phlebotomies were needed.
- Prolonged Duration of Benefit: For 14 patients with extended follow-up, the median time to first phlebotomy was 287 days after the last dose, highlighting a long-lasting therapeutic effect.
- Symptom and Quality-of-Life Improvements: Most patients experienced notable improvements in MPN-10 total symptom scores through Week 34, suggesting divesiran may address both disease symptoms and overall patient well-being.
- Favorable Safety Profile: Divesiran was well tolerated with no dose-limiting toxicities. The most common side effects were mild, transient injection-site reactions. No treatment-related serious adverse events or discontinuations were reported.
Clinical Program Update: Next Steps and Potential Milestones
- Phase 2 SANRECO Study: This ongoing global, randomized, placebo-controlled, double-blind trial is evaluating divesiran (6 mg, subcutaneously, every 6 or 12 weeks) in 48 phlebotomy-dependent PV patients with uncontrolled hematocrit despite standard therapies (hydroxyurea, interferon, and/or ruxolitinib).
- Primary Endpoint: The proportion of patients achieving a response between weeks 18–36, defined by absence of “phlebotomy eligibility” (hematocrit ≥45%).
- Upcoming Catalyst: Topline results from this pivotal Phase 2 study are expected in August 2026, which could be a significant share price catalyst depending on outcome.
Why This Matters for Investors
- Transformative Potential: Divesiran, a wholly owned siRNA candidate from Silence’s proprietary mRNA GOLD™ platform, is the first therapy to directly target TMPRSS6 to modulate iron metabolism and reduce red blood cell production, addressing a key driver in PV.
- Addressing a High-Unmet Need: PV is a chronic blood cancer with serious risks (e.g., thrombosis, progression to myelofibrosis or AML) and limited treatment options. There are currently no approved therapies specifically targeting red blood cell production and hematocrit.
- Differentiation vs. Standard of Care: Current PV management relies on frequent phlebotomies and cytoreductive drugs. Divesiran’s durable efficacy and potential for less frequent dosing (every 12 weeks) could be a major advancement, improving patient experience and healthcare resource use.
- Regulatory Momentum: Divesiran has FDA Fast Track and Orphan Drug designations for PV, potentially expediting development and regulatory review.
- Positive Safety and Efficacy Signals: The Phase 1 data demonstrate both safety and durable efficacy—key de-risking events for shareholders.
- Pivotal Data Ahead: The upcoming Phase 2 topline results in August 2026 represent a significant inflection point for the company and could impact the valuation depending on outcomes.
About Divesiran and Mechanism of Action
Divesiran works by silencing TMPRSS6, a liver-expressed gene that suppresses hepcidin (the master regulator of iron metabolism). By increasing hepcidin, divesiran restricts iron availability to the bone marrow, thereby reducing excessive red blood cell production—a hallmark of PV.
The drug is currently in Phase 2 development and represents a novel, targeted approach to managing PV. Silence Therapeutics retains full ownership of divesiran.
About Silence Therapeutics
Silence Therapeutics is a global, clinical-stage biotechnology company specializing in precision-engineered siRNA medicines via its proprietary mRNAi GOLD™ platform. The company is advancing programs in cardiovascular, hematology, and rare diseases, focusing on areas with high unmet medical need.
Contact and Further Information
- Investor Relations: Gem Hopkins, VP, Head of IR and Corporate Communications ([email protected], +1 646-637-3208)
- Media Relations: Mary Conway, MKC Strategies ([email protected], +1 516-606-6545)
- For more information, visit Silence Therapeutics website.
Disclaimer
This article is for informational purposes only and does not constitute investment advice or an offer to buy or sell any securities. Investors should be aware that this article contains forward-looking statements based on current expectations, which are subject to risks and uncertainties. Actual results may differ materially. Please consult Silence Therapeutics’ filings with the SEC and seek professional advice before making investment decisions.
