Silence Therapeutics plc filed a current report on August 10, 2026, disclosing positive topline results from the Phase 2 SANRECO trial evaluating divesiran in polycythemia vera.

Key Highlights

  • Primary endpoint met: 88% of divesiran-treated patients achieved clinical response versus 19% for placebo (p<0.0001).
  • Dose group response rates: Q6W dosing achieved 93.8% and Q12W achieved 81.3% primary endpoint response rates.
  • Phlebotomy reduction: Mean phlebotomies per patient were 0.2 in divesiran groups versus 2.1 in the placebo group (p<0.0001).
  • Trial design: The study was a 36-week, randomized, double-blind, placebo-controlled portion of the Phase 2 trial, evaluating divesiran at 6 mg/kg administered subcutaneously every six or twelve weeks.
  • Safety profile: According to the filing, divesiran was observed to be well tolerated with no new safety findings; two investigator-reported grade 1 anemia adverse event cases were noted.
  • Phase 3 plans: The company disclosed it expects to initiate a Phase 3 trial evaluating divesiran for Q12W dosing versus placebo in the first half of 2027.

SANRECO Phase 2 Trial Data: What the Filing Discloses

Silence Therapeutics plc (NASDAQ: SLN), incorporated in England and Wales and headquartered at 12 Hammersmith Grove, London, filed a current report under Item 7.01 and Item 8.01 on August 10, 2026, announcing topline results from the Phase 2 SANRECO trial of its investigational therapy divesiran in polycythemia vera (PV). The filing reports that the trial's primary endpoint and secondary endpoints were met.

According to the filing, the primary endpoint was defined as 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." The filing states that 88% of divesiran-treated patients met this definition versus 19% in the placebo group (p<0.0001). The filing further notes that both dosing arms showed efficacy individually, with Q6W at 93.8% and Q12W at 81.3%.

On the key secondary endpoint, the filing states that the mean number of phlebotomies per patient during weeks 0-36 was 0.2 for divesiran groups and 2.1 for placebo (p<0.0001). The filing also notes improvements in hematocrit control, iron markers including ferritin, and patient-reported outcomes using the MPN-SAF Total Symptom Score. Regarding safety, the filing states injection site reactions were "infrequent and self-limiting" and that there were two investigator-reported grade 1 anemia adverse event cases. The company's statement about initiating a Phase 3 trial in the first half of 2027 is characterized in the filing as a forward-looking statement subject to risks and uncertainties.

What Was Disclosed

The filing discloses topline Phase 2 SANRECO trial results for divesiran in polycythemia vera, reporting that primary and secondary endpoints were met, and that the company expects to initiate a Phase 3 trial in the first half of 2027, subject to the company's own cautionary language.