Benzinga | Jul 13, 2021 04:13PM EDT

scPharmaceuticals Inc. Announces Mean Difference In Heart Failure-Related Costs Between Two Groups Was $17,753 Per STudy Subject

scPharmaceuticals Inc. (NASDAQ:SCPH), 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 top-line results from its FREEDOM-HF study. FREEDOM-HF was a prospective clinical trial evaluating overall and heart failure-related costs of treating congestion in patients with chronic heart failure. Patients were treated with FUROSCIX(r), our investigational product, post-discharge from the emergency department compared to a historical comparator group that was treated with intravenous furosemide in the inpatient hospital setting.

Based on the results from a planned, prespecified interim analysis conducted to confirm the final sample size, and following input from statisticians, principal investigators, payer advisors and Health Economics and Outcomes Research (HEOR) experts, enrollment was stopped on May 17, 2021, prior to the enrollment target of 34 patients. This decision was made due to the highly statistically significant reduction observed in 30-day heart failure-related costs in patients who received FUROSCIX in the interim analysis. The final analysis included 24 subjects treated with FUROSCIX and 66 matched comparators based on seven variables associated with hospitalization.

Comparator patients hospitalized for 72 hours or less were identified, and costs were derived from service-level claims utilizing IBM(r) MarketScan(r) Research Databases which utilizes coding to standardize financial data from fully paid and adjudicated claims.

Results Summary:

* The mean difference in heart failure-related costs between the two groups was $17,753 per study subject, with a p-value of p<0.0001 (95% CI: -$23,660, -$11,846), favoring the FUROSCIX group.

* This difference in costs was driven primarily by hospitalization costs. Per protocol, all subjects (24/24) who were enrolled in the study and received FUROSCIX did not require an initial heart failure hospitalization, and all but one (95.8%) remained out of the hospital for heart failure for the subsequent 30-day period.

* In the comparator group, 100% of the patients were initially hospitalized and 10.6% had a heart failure-related readmission.

* As part of the study design, all FUROSCIX patients were required to have at least one heart failure related clinic visit during the study period. In the comparator group, 34.9% of subjects had a heart failure related clinic visit.

* Since the price for FUROSCIX has not been established, the difference in costs does not include the cost of FUROSCIX.

* Additional analyses, including 30-day overall healthcare cost, quality of life as well as patient and caregiver satisfaction, are ongoing and complete data will be submitted for publication or presentation at an upcoming scientific meeting.

* The most common adverse events with FUROSCIX were infusion site pain, bruising and dizziness and no serious adverse events related to FUROSCIX were observed.

"These positive results from our pharmacoeconomic study support our hypothesis that treating heart failure patients with FUROSCIX has the potential to dramatically reduce the significant costs associated with admission or readmission to the hospital," stated John Tucker, chief executive officer of scPharmaceuticals. "As we continue to work toward the resubmission of our new drug application (NDA) later this year, this study provides powerful evidence to payers on the potential economic benefit of FUROSCIX, if approved."

"We currently lack a tool designed to manage worsening congestion in the outpatient setting in patients with chronic heart failure when oral diuretics are inadequate. This results in heart failure being one of the most common causes of hospital admissions in patients over 65 years of age," stated Dan Bensimhon, MD, Medical Director Advanced Heart Failure & Mechanical Circulatory Support Program, Cone Health. "I believe FUROSCIX, if approved, could represent an important new tool to manage heart failure in the outpatient setting."

"It has been estimated that up to 90% of patients presenting to the emergency department with symptoms of worsening heart failure are admitted to the hospital, and 50% of these admissions may be potentially avoided," stated James Kenney, RPh, MBA, president of JTKENNEY, LLC, a managed care pharmacy consultancy. "The direct medical costs of heart failure are projected to surpass $53 billion by 2030, with 80% of these expenditures being related to hospitalization. If approved, FUROSCIX has the potential to significantly reduce such costs by shifting management of appropriate patients with congestion from the inpatient to the outpatient setting."

Conference Call and Webcast

scPharmaceuticals' management, Dr. Bensimhon and Mr. Kenney will host a conference call and live webcast tomorrow, July 14, at 8:30 am ET.

Investor Dial-in: 877-407-9208

Int'l Investor Dial-in: 201-493-6784

Conference ID: 13721167

Webcast: http://public.viavid.com/index.php?id=145533

About FREEDOM-HF