Silence Therapeutics Completes Patient Enrollment in Phase 2 Study of Divesiran

Silence Therapeutics plc (NASDAQ:SLN), a global clinical-stage company developing novel siRNA (short interfering RNA) therapies, today announced it has completed patient enrollment in the SANRECO Phase 2 study of divesiran, a first-in-class siRNA targeting TMPRSS6, for the treatment of polycythemia vera (PV). Initial topline results from the SANRECO Phase 2 study are anticipated in the third quarter of 2026.

SANRECO is a global, randomized, double-blind, placebo-controlled Phase 2 study that enrolled 48 phlebotomy-dependent PV patients. The primary endpoint is the proportion of patients receiving divesiran compared to placebo who maintain hematocrit (HCT) levels below 45% without phlebotomies between weeks 18 and 36. PV patients face a higher risk of thrombotic events, including heart attack and stroke, when HCT levels are not maintained at target levels (<45%). Secondary endpoints include safety and tolerability, pharmacokinetics, and quality of life changes.

"The rapid completion of Phase 2 enrollment highlights the growing enthusiasm for divesiran and novel treatment options to address the significant unmet need in PV," said Craig Tooman, President and Chief Executive Officer at Silence. "Despite currently approved treatment options, a serious unmet need exists for patients seeking continuous hematocrit and symptom control, improved quality of life, and more convenient dosing, which we believe divesiran has the potential to address as a first-in-class siRNA. We extend our sincerest thanks to the patients, investigators, and collaborative partners who made the achievement of this important milestone possible."

Results from the Phase 1 portion of the SANRECO study showed divesiran's potential to maintain HCT to target levels following infrequent dosing (every six weeks) without the need for phlebotomies in the target population. Based on the sustained duration of effect observed in Phase 1, the Phase 2 study includes a second, longer dosing interval of every 12 weeks.