Silence Therapeutics (NASDAQ: SLN) has announced 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).
According to Silence, the trial met its primary endpoint, with a significantly higher proportion of clinical responders on divesiran—88% compared with 19% for placebo. Divesiran was observed to be well tolerated, with no new safety findings, and the dose groups showed substantial efficacy on the primary endpoint.
In a statement, Marina Kremyanskaya, MD, PhD, associate professor of medicine, ematology and medical oncology, at the Icahn School of Medicine at Mount Sinai, commented, “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. 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.”
Curtis Rambaran, MD, CMO at Silence, added, “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. 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.”
