news release
| View printer-friendly version |
| << Back |
SCP-111 Autoinjector achieved primary pharmacokinetic and secondary pharmacodynamic endpoints
The autoinjector is being developed to deliver a subcutaneous injection of furosemide as an alternative option to the FDA approved FUROSCIX on-body infusor presentation
Company targeting Supplemental New Drug Application (sNDA) submission to the FDA by year-end 2024
The objectives of the study were to estimate the bioavailability and describe the PK and pharmacodynamics (PD) of SCP-111 (furosemide 80 mg/1 mL) administered as a subcutaneous injection via an autoinjector compared with the equivalent dose of furosemide administered as two 40mg IV injections administered over 1-to-2 minutes, two hours apart and to describe the safety and tolerability of the SCP-111 injection.
Key highlights of the topline results from the study:
- SCP-111 demonstrated a bioavailability of 107.3% (90% CI: 103.9 - 110.8), achieving the 90% confidence interval limit of 80 to 125 percent
- Participants that received SCP-111 had similar urine output, urinary sodium excretion and urinary potassium excretion at 6, 8 and 12 hours compared to IV furosemide
- Participants reported a median pain score of 0 across all time points assessed
- The most common adverse events with SCP-111 were localized to the injection site and systemic adverse events were consistent with those reported in the prescribing information for intravenous and oral furosemide
“With these positive topline data now in-hand, we continue to work towards our targeted submission of an sNDA to the FDA by the end of this year,” stated
This study was an open-label, single-center, single-dose, randomized, two-way crossover study in twenty-one healthy volunteers, ranging in age from 45 to 80. Each subject completed the screening, baseline, treatment, and follow-up phases. Subjects were randomly assigned in a 1:1 ratio to one of two treatment sequences (IV furosemide followed by SCP-111 via the autoinjector, or vice versa).
scPharmaceuticals plans to submit the full data set from this study for future presentation at a medical meeting or publication.
About scPharmaceuticals
scPharmaceuticals is a pharmaceutical company focused on developing and commercializing products that are designed to reduce healthcare costs and improve health outcomes. The Company develops, internally and through strategic partnerships, innovative products and solutions that aim to expand and advance the outpatient care of select acute conditions. The Company’s lead programs focus on the subcutaneous, self-administration of IV-strength treatments in heart failure and infectious disease. scPharmaceuticals is headquartered in
Forward-Looking Statement
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding the clinical development and regulatory progress of SCP-111, including the results from the PK study and planned sNDA submission, and the timing thereof; the potential benefits of the administration of furosemide via an autoinjector for providers and patients; and the submission of the data set from the PK study for any future presentations or publications. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risks associated with the enrollment of patients in and timely completion of clinical trials; clinical and preclinical development involves a lengthy and expensive process with an uncertain outcome, and any difficulties or delays in the commencement or completion, or the termination or the potential for the results from any clinical trials to support submission of sNDAs or comparable regulatory applications; interim, “topline” and preliminary data from our clinical trials and preclinical studies are subject to audit and verification procedures that could result in material changes in the final data; if we are unable to expand our sales and marketing capabilities or continue to enter into agreements with third parties to market and sell FUROSCIX, we may be unable to generate any revenue; we have a limited operating history and no history of commercializing pharmaceutical products, which may make it difficult to evaluate the prospects for our future success; we have a history of significant operating losses and expect to incur significant and increasing losses for the foreseeable future; and we may never achieve or maintain profitability;. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the sections entitled “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended
scPharmaceuticals Inc., 781-301-6869
kmiranda@scpharma.com
Investors:
PJ Kelleher
pkelleher@lifesciadvisors.com
