Scpharmaceuticals Inc (NASDAQ: SCPH) Announces Highly Statistically Significant Results From Its FREEDOM-HF Study

Scpharmaceuticals Inc (NASDAQ: SCPH) recently announced highly statistically significant positive results from its FREEDOM-HF clinical trial, aimed at evaluating overall and heart-failure-related treatment costs for congestion in patients with chronic heart failure (CHF). Patients were treated with the company’s investigational subcutaneous furosemide injection product, FUROSCIX®, post-discharge from the emergency department. In addition, these patients were compared to a historical comparator group treated with intravenous furosemide injection in the in-patient hospital setting. 

Scpharmaceuticals’ final analysis, based on seven variables associated with hospitalization, included 24 patients in the FUROSCIX group and 66 in the comparators group. The pre-specified interim analysis reported a mean difference of $17,753 per patient in heart failure-related treatment costs, with a p-value of p<0.0001, supporting the FUROSCIX group. Given the highly significant positive results, enrolment was stopped on May 17, 2021, before reaching the target of 34 patients in the intervention group, following input from principal investigators, Health Economics and Outcomes Research experts, payer advisors, and statisticians. 

Clinical trial results summary

Scpharmaceuticals’ FREEDOM-HF clinical trial was aimed at real-world evaluation of differences in heart failure and overall costs between subjects receiving FUROSCIX outside the hospital and patients receiving intravenous furosemide in the hospital setting. It was a multi-center prospective clinical study, where patients in the FUROSCIX group were required to have at least one heart failure-related hospital visit during the trial. In the comparison group, about 35% of patients had a clinic visit. The positive findings and reduced cost of treatment favoring FUROSCIX were mainly related to hospitalization costs. All the 24 patients enrolled in the FUROSCIX group didn’t require an initial heart failure hospitalization. The company reported that additional analysis including 30-day overall healthcare cost, quality of life, patient and caregiver satisfaction are ongoing.

Management commentary about trial results

John Tucker, Chief Executive Officer of Scpharmaceuticals, mentioned that the positive results from the pharmaco-economic data related to the FREEDOM-HF study support the underlying hypothesis that FUROSCIX can dramatically reduce costs treatment-related to hospital admission/readmission in heart failure patients. The management is working toward the resubmission of FUROSCIX-related new drug application later this year. 

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