scPharmaceuticals Reports Positive Study Results for SCP-111 Autoinjector

scPharmaceuticals Inc. has announced promising results from a pharmacokinetic study of SCP-111, a low-volume, pH-neutral furosemide formulation administered through an autoinjector. This device is being developed as an alternative to the FDA-approved FUROSCIX on-body infusor. The company aims to submit a Supplemental New Drug Application (sNDA) to the FDA by the end of 2024.

The main goals of the study were to determine the bioavailability and describe the pharmacokinetics (PK) and pharmacodynamics (PD) of SCP-111 when delivered as a subcutaneous injection. This was compared to the same dose of furosemide administered intravenously (IV) in two separate 40 mg injections given two hours apart. Additionally, the study assessed the safety and tolerability of SCP-111.

Key findings demonstrated that SCP-111 achieved a bioavailability of 107.3%, meeting the confidence interval limit of 80 to 125 percent. Participants who received SCP-111 showed similar urinary output and sodium and potassium excretion levels at 6, 8, and 12 hours compared to those who received IV furosemide. Notably, participants reported a median pain score of zero throughout all time points assessed. The most common adverse events were localized to the injection site, with systemic adverse events aligning with those seen with intravenous and oral furosemide.

John Tucker, CEO of scPharmaceuticals, commented on the results, stating that the company is on track with its goal to submit an sNDA to the FDA by the end of the year. He believes that, if approved, the autoinjector will offer greater treatment flexibility for cardiologists, heart failure specialists, and their patients.

The study was an open-label, single-center, single-dose, randomized, two-way crossover study involving twenty-one healthy volunteers aged between 45 and 80. Each participant completed various phases including screening, baseline, treatment, and follow-up. Subjects were randomly assigned to one of two treatment sequences: either IV furosemide followed by SCP-111 via autoinjector or the reverse order.

scPharmaceuticals plans to present the complete data set from this study at a future medical meeting or through publication. The company focuses on developing and commercializing products aimed at reducing healthcare costs and enhancing health outcomes. Their lead programs emphasize the subcutaneous self-administration of IV-strength treatments, particularly for heart failure and infectious diseases.

The company, headquartered in Burlington, MA, develops these innovative products internally and through strategic partnerships, aiming to advance outpatient care for specific acute conditions.