scPharmaceuticals Inc. Announces Positive Results from AT HOME-HF Phase 2 Pilot Study in Heart Failure

July 18, 2022 – scPharmaceuticals Inc., a pharmaceutical company focused on developing and commercializing products that can optimize the delivery of infusion therapies, advance patient care and reduce healthcare costs, has today announced positive results from the pilot AT HOME-HF study, a randomized, multicenter Phase 2 study that compared scPharmaceuticals’ investigational product, FUROSCIX (furosemide 80mg/10ml for subcutaneous administration), with an approach of “usual treatment” in patients with chronic heart failure presenting to a heart failure clinic with worsening congestion and requiring increased diuresis.

The study enrolled 51 subjects, of whom 34 received FUROSCIX and 17 received ‘as usual’.

Data Highlights:

  • There was a positive trend in the Finkelstein-Schoenfeld success ratio of the hierarchical primary composite endpoint including cardiovascular deaths, heart failure hospitalizations, heart failure emergency department visits, and percent change from baseline. baseline NT-proBNP value on day 7 in the FUROSCIX group compared to the “usual treatment” group in several populations analyzed.
  • Subjects randomized to FUROSCIX had a 37% reduced risk of hospitalization for heart failure compared to patients randomized to receive “usual treatment” on day 30.
  • All pre-specified secondary endpoints measuring congestion symptoms, quality of life, and functional status favored the FUROSCIX group and included a two-kilogram greater weight loss on day three and a 12-point increase in the questionnaire Kansas City Cardiomyopathy 12-point (KCCQ-12) summary scores at Day 7 and Day 30.
  • There were 11 subjects who 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 mild infusion site pain. There was one serious adverse event (dehydration) that was assessed by the investigator as possibly related to FUROSCIX, which disappeared. 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 as no being unrelated to FUROSCIX.

The AT HOME-HF pilot study was only descriptive and did not include a strong statistical hypothesis test.

“We are pleased with the results of the AT HOME-HF pilot study where, despite a small sample size, subjects treated with FUROSCIX experienced greater decongestion and significant improvement in symptoms and functional status compared to to ‘usual treatment’,” said Dr. Marvin Konstam, MD, professor of medicine at Tufts University School of Medicine and chief medical officer of the Cardiovascular Center at Tufts Medical Center. “Data from this study will be informative for the design and determination of sample size for a potential larger clinical trial.”

“With a 37% reduction in heart failure hospitalizations compared to ‘usual treatment’ and improvement in signs and symptoms of congestion seen in the AT HOME-HF pilot study, a positive PK/PD study demonstrating a bioavailability of 99 .6% and comparable diuresis and natriuresis for FUROSCIX versus IV furosemide, and approximately $17,000 reduction in heart failure costs over 30 days with FUROSCIX observed in the FREEDOM-HF study, the totality of available evidence regarding FUROSCIX strongly supports its value proposition,” said John Tucker, Managing Director of scPharmaceuticals. “As we approach our PDUFA date of October 8, 2022, we are excited and look forward to the commercial launch of FUROSCIX, if approved, in the fourth quarter of this year.”

About the AT HOME-HF Phase 2 Pilot Study

The purpose of the AT HOME-HF pilot study was to provide pilot data on the efficacy 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 patients with heart failure with worsening congestion that was conducted to assess clinical outcomes and safety of FUROSCIX versus a “treat as usual” approach. Subjects eligible based on the inclusion and exclusion criteria were randomized to receive (in a 2:1 randomization scheme) FUROSCIX or ‘usual treatment’. The primary endpoint was a 30-day hierarchical composite of cardiovascular deaths, heart failure hospitalizations, heart failure emergency department visits, and % change in NT-proBNP at day 7 from baseline, using the Finkelstein-Schoenfeld success report. The Finkelstein-Schoenfeld winning ratio is a statistical method used to compare the composite results for each pair in a clinical trial of the treatment group and the control group. Pre-specified secondary endpoints were assessed from baseline over the 30-day study period and included days alive and event-free of heart failure, global assessment via a visual scale analogue, composite clinical congestion score, Likert dyspnea at 5 and 7 points. scores, health-related quality of life as measured by the KCCQ-12 Short Form Summary Score, serum creatinine, weight, six-minute walk test, and ReDS® (Remote Dielectric Sensing) pulmonary fluid measurement. The study did not include a powerful statistical hypothesis test. Enrollment started in Q2-2021 and ended in Q1-2022.

FUROSCIX (furosemide) 80 mg/10 ml for subcutaneous administration

FUROSCIX is a proprietary, investigational furosemide solution formulated at neutral pH, designed to allow subcutaneous infusion via a portable, pre-programmed drug delivery system on the body, for self-administration on an outpatient basis. FUROSCIX is currently in 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 exhibit a reduced response to oral diuretics and which 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

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