| | • | | There were 11 subjects that experienced 21 adverse events during the 30-day study period that were determined by the investigator to be related to FUROSCIX. The most common related adverse event was infusion site pain that was mild in severity. There was one serious adverse event (dehydration) that was assessed by the investigator as possibly related to FUROSCIX, which resolved. During the 30-day study period, there was one death (sudden cardiac death) in the FUROSCIX group which occurred on study day 30 and was assessed by the investigator to be not related to FUROSCIX. |
The AT HOME-HF Pilot study was descriptive only and did not include a powered statistical hypothesis test.
“We are pleased with the results from the AT HOME-HF Pilot study where, despite a small sample size, subjects treated with FUROSCIX had greater decongestion and significant improvement in symptoms and functional status compared to ‘treatment as usual,’” said Dr. Marvin Konstam, M.D., Professor of Medicine at Tufts University School of Medicine and Chief Physician Executive of the Cardiovascular Center at Tufts Medical Center. “The data from this study will be informative in designing and determining the sample size for a potential larger clinical trial.”
“With a 37% reduction in heart failure hospitalizations relative to ‘treatment as usual’ and improvement in congestion signs and symptoms observed in the AT HOME-HF Pilot study, a positive PK/PD study demonstrating 99.6% bioavailability and comparable diuresis and natriuresis for FUROSCIX compared to IV furosemide, and a reduction of approximately $17,000 in 30-day heart failure related costs with FUROSCIX observed in the FREEDOM-HF study, the totality of the available evidence regarding FUROSCIX strongly supports its value proposition,” said John Tucker, chief executive officer of scPharmaceuticals. “As we approach our October 8, 2022 PDUFA date, we are excited and look forward to commercial launch of FUROSCIX, if approved, in the fourth quarter of this year.”
About AT HOME-HF Phase 2 Pilot Study
The objective of the AT HOME-HF Pilot study was to provide pilot data on the effectiveness and safety of FUROSCIX to inform a potentially larger trial. The AT HOME-HF Pilot study is a Phase 2, multicenter, randomized, proof-of-concept study in heart failure patients with worsening congestion that was conducted to evaluate the clinical outcomes and safety of FUROSCIX compared to a “treatment as usual” approach. Eligible subjects based on inclusion and exclusion criteria were randomized to receive (in a 2:1 randomization scheme) FUROSCIX or “treatment as usual.” The primary endpoint was a 30-day hierarchal composite of cardiovascular death, heart failure hospitalizations, emergency department visits for heart failure and % change of NT-proBNP at day seven from baseline, utilizing the Finkelstein- Schoenfeld win ratio. The Finkelstein-Schoenfeld win ratio is a statistical method used to compare composite outcomes for every pair in a clinical trial from the treatment and control group. The pre-defined secondary endpoints were evaluated from baseline across the 30-day study period and included the number of days alive and heart failure event free, global assessment via visual analog scale, composite clinical congestion score, 5- and 7-point Likert dyspnea scores, health-related quality of life measured by the KCCQ-12 short form summary score, serum creatinine, weight, six-minute walk test and ReDS® (Remote Dielectric Sensing) lung fluid measurement. The study did not include a powered statistical hypothesis test. Enrollment commenced in Q2-2021 and was completed in Q1-2022.
