July 18, 2022 — scPharmaceuticals Inc., a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced positive results from the AT HOME-HF Pilot study, a Phase 2, multicenter, randomized study that compared scPharmaceuticals’ investigational product, FUROSCIX (furosemide 80 mg/10 mL for subcutaneous administration), with a “treatment as usual” approach in chronic heart failure patients presenting to a heart failure clinic with worsening congestion and requiring augmented diuresis.
The study enrolled 51 subjects, of which 34 received FUROSCIX and 17 received “treatment as usual.”
- There was a positive trend in the Finkelstein-Schoenfeld win ratio of the hierarchal primary composite endpoint consisting of cardiovascular death, heart failure hospitalizations, emergency department visits for heart failure and % change from baseline of NT-proBNP at day seven in the FUROSCIX group compared to the “treatment as usual” group across multiple analysis populations.
- Subjects randomized to FUROSCIX had a 37% reduction in the risk of a heart failure hospitalization relative to patients randomized to “treatment as usual” at day 30.
- All pre-defined secondary endpoints measuring symptoms of congestion, quality of life and functional status favored the FUROSCIX group and included a two kilogram greater weight loss at day three and a 12-point increase in the 12 item Kansas City Cardiomyopathy Questionnaire (KCCQ-12) summary scores at day 7 and day 30.
- 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.
FUROSCIX (Furosemide) 80 mg/10mL for Subcutaneous Administration
FUROSCIX is an investigational, proprietary furosemide solution formulated to a neutral pH, designed to allow for subcutaneous infusion via a wearable, pre-programmed on-body drug delivery system, for outpatient self-administration. FUROSCIX is currently under development for the treatment of congestion due to fluid overload in adult patients with New York Heart Association (NYHA) Class II and Class III chronic heart failure who display reduced responsiveness to oral diuretics and who do not require hospitalization. If approved, FUROSCIX has the potential to provide an outpatient alternative for the treatment of worsening heart failure due to congestion.
For more information: www.scPharmaceuticals.com