Healthcare Professionals
SANRECO STUDY
The SANRECO phase 2 clinical study is evaluating a potential new treatment, SLN124 (divesiran), for patients with polycythemia vera (PV).
Study Overview
SANRECO (NCT05499013) is a phase 1/2 study with an open-label dose escalation phase followed by a randomized, double-blind phase of divesiran in patients with PV. Silence has completed enrollment of the phase 2 SANRECO study, which is now ongoing to evaluate divesiran in the treatment of polycythemia vera (PV).
Phase 2 Endpoints
Primary Endpoint: Measure the percentage of patients whose hematocrit (Hct) stays below 45% without phlebotomies between weeks 18 and 36
Secondary Endpoints:
- Number of phlebotomies required
- Safety and tolerability
- Pharmacokinetics
- Quality of life outcomes
Visit Schedule & Time Commitment
Study Duration: Up to 183 weeks (approximately 3.5 years)
- On-study participation: 180 weeks (approximately 3.5 years)
Phase 2 Periods:
Placebo-Controlled Double-Blind Period (Weeks 0–36)
- Patients receive divesiran or placebo every 6 weeks
Double-Blind Extension Period
(Weeks 36-144)
- Placebo recipients are re-randomized to divesiran
Double-Blind Extension Period
(Weeks 36-144)
- Placebo recipients are re-randomized to divesiran
Open-Label Extension Period (Weeks 36-144)
- All participants receive divesiran
- Dose frequency will be determined based on phase 2 data
Patients are seen every 6 weeks during the study.
Safety Monitoring
Patients undergo safety assessments and other physical, clinical, and laboratory health evaluations during clinic visits scheduled over the course of the study.
Divesiran Phase 1 Results
Early data from the completed phase 1 portion of the SANRECO study show divesiran has been safe and well tolerated by adult patients with PV.
- The phase 1 portion of SANRECO is a 34-week (8 months), open-label study evaluating divesiran (3 mg/kg (n=6), 6 mg/kg (n=8) and 9 mg/kg (n=7)) administered subcutaneously every 6 weeks for four doses, with a 16-week (approximately 4 months) follow-up period following the date of the last administered dose in 21 patients with PV. A total of 21 patients (32-71 years of age) were included in the latest analysis with a Hct baseline range of 39-59%1.
- Results from the SANRECO clinical study presented during the 2024 ASH Annual Meeting showed that divesiran reduced phlebotomy frequency in patients (n = 21). A total of 79 phlebotomies occurred across all patients prior to dosing. Following divesiran dosing, five phlebotomies occurred during the 18-week (approximately 4 months) treatment period – all were in patients who entered the study with high baseline HCT levels (over 45%). Two phlebotomies occurred in the 16-week follow-up period following the last administered dose. Divesiran also induced hepcidin in all patients and decreased hematocrit in all cohorts of patients treated1.
- Additionally, patients did not experience any dose-limiting toxicities. Most treatment-emergent adverse effects (TEAEs) were grade 1 in severity (84%) and there were no TEAEs above grade 2 reported. 52 mild self-limiting injection site reactions were observed in 13/21 participants1.
More information about SANRECO can be found here.
1. Kremyanskaya, Marina, et al. Initial results from a phase 1/2 study evaluating divesiran, a novel galnac conjugated siRNA, in patients with polycythemia vera (SANRECO). Blood. 2024;144(suppl 1):656. doi:10.1182/blood-2024-205854
Divesiran Phase 1 Results
Early data from the completed phase 1 portion of the SANRECO study show divesiran has been safe and well tolerated by adult patients with PV.
- The phase 1 portion of SANRECO is a 34-week (8 months), open-label study evaluating divesiran (3 mg/kg (n=6), 6 mg/kg (n=8) and 9 mg/kg (n=7)) administered subcutaneously every 6 weeks for four doses, with a 16-week (approximately 4 months) follow-up period following the date of the last administered dose in 21 patients with PV. A total of 21 patients (32-71 years of age) were included in the latest analysis with a Hct baseline range of 39-59%1.
- Results from the SANRECO clinical study presented during the 2024 ASH Annual Meeting showed that divesiran reduced phlebotomy frequency in patients (n = 21). A total of 79 phlebotomies occurred across all patients prior to dosing. Following divesiran dosing, five phlebotomies occurred during the 18-week (approximately 4 months) treatment period – all were in patients who entered the study with high baseline HCT levels (over 45%). Two phlebotomies occurred in the 16-week follow-up period following the last administered dose. Divesiran also induced hepcidin in all patients and decreased hematocrit in all cohorts of patients treated1.
- Additionally, patients did not experience any dose-limiting toxicities. Most treatment-emergent adverse effects (TEAEs) were grade 1 in severity (84%) and there were no TEAEs above grade 2 reported. 52 mild self-limiting injection site reactions were observed in 13/21 participants1.
More information about SANRECO can be found here.
1. Kremyanskaya, Marina, et al. Initial results from a phase 1/2 study evaluating divesiran, a novel galnac conjugated siRNA, in patients with polycythemia vera (SANRECO). Blood. 2024;144(suppl 1):656. doi:10.1182/blood-2024-205854