scPharmaceuticals Announces Positive Topline Study Results for SCP-111 (Furosemide 80 mg/1 mL) Autoinjector
scPharmaceuticals Inc. (SCPH) announced positive topline results from a pharmacokinetic study of SCP-111, an investigational furosemide autoinjector. The study achieved its primary and secondary endpoints, demonstrating 107.3% bioavailability compared to IV furosemide. SCP-111 showed similar urine output and electrolyte excretion to IV furosemide, with minimal pain reported at injection sites. The company aims to submit a Supplemental New Drug Application (sNDA) to the FDA by year-end 2024.
The study involved 21 healthy volunteers aged 45-80 in a randomized, two-way crossover design. If approved, SCP-111 could provide an alternative to the current FUROSCIX on-body infusor, potentially offering greater treatment flexibility for cardiologists and heart failure patients.
scPharmaceuticals Inc. (SCPH) ha annunciato risultati positivi dai risultati preliminari di uno studio farmacocinetico su SCP-111, un autoiniettore sperimentale di furosemide. Lo studio ha raggiunto i suoi obiettivi primari e secondari, dimostrando una biodisponibilità del 107,3% rispetto alla furosemide IV. SCP-111 ha mostrato un output urinario e un'escrezione di elettroliti simili a quelli della furosemide IV, con un dolore minimo segnalato nei siti di iniezione. L'azienda prevede di presentare una Domanda di Nuovo Farmaco Supplementare (sNDA) all'FDA entro la fine del 2024.
Lo studio ha coinvolto 21 volontari sani di età compresa tra 45 e 80 anni in un design crossover randomizzato a due vie. Se approvato, SCP-111 potrebbe fornire un'alternativa all'attuale infusore portatile FUROSCIX, offrendo potenzialmente una maggiore flessibilità terapeutica per cardiologi e pazienti con insufficienza cardiaca.
scPharmaceuticals Inc. (SCPH) anunció resultados positivos de los resultados preliminares de un estudio farmacocinético de SCP-111, un autoinyector de furosemida en investigación. El estudio cumplió con sus objetivos primarios y secundarios, demostrando una biodisponibilidad del 107,3% en comparación con la furosemida IV. SCP-111 mostró una producción de orina y excreción de electrolitos similares a los de la furosemida IV, con un dolor mínimo reportado en los sitios de inyección. La compañía tiene como objetivo presentar una Solicitud de Nuevo Medicamento Suplementario (sNDA) a la FDA para finales de 2024.
El estudio involucró a 21 voluntarios sanos de entre 45 y 80 años en un diseño cruzado aleatorio de dos vías. Si se aprueba, SCP-111 podría ofrecer una alternativa al infusor portatil FUROSCIX, lo que podría proporcionar una mayor flexibilidad en el tratamiento para cardiólogos y pacientes con insuficiencia cardíaca.
scPharmaceuticals Inc. (SCPH)는 SCP-111, 실험용 부루세미드 자동 주사기의 약리학적 연구에서 긍정적인 초기 결과를 발표했습니다. 이 연구는 주요 및 부수적 목표를 달성했으며, IV 부루세미드와 비교하여 107.3%의 생체이용률을 보여주었습니다. SCP-111은 IV 부루세미드와 유사한 요 출량과 전해질 배설을 보여주었으며, 주사 부위에서 최소한의 통증이 보고되었습니다. 회사는 2024년 말까지 FDA에 보충 새 약물 신청서 (sNDA)를 제출할 계획입니다.
이 연구는 45세에서 80세 사이의 건강한 자원봉사자 21명을 무작위 이중 교차 설계로 모집했습니다. 승인이 이루어진다면, SCP-111은 현재 FUROSCIX 이동식 주입기에 대한 대안을 제공하여 심장 전문의와 심부전 환자에게 더 큰 치료 유연성을 제공할 수 있을 것입니다.
scPharmaceuticals Inc. (SCPH) a annoncé des résultats préliminaires positifs d'une étude pharmacocinétique sur SCP-111, un autoinjecteur expérimental de furosémide. L'étude a atteint ses objectifs primaires et secondaires, démontrant une biodisponibilité de 107,3% par rapport au furosémide IV. SCP-111 a montré une production d'urine et une excrétion d'électrolytes similaires à celles du furosémide IV, avec peu de douleur signalée au niveau des sites d'injection. L'entreprise vise à soumettre une Demande de Nouveau Médicament Supplémentaire (sNDA) à la FDA d'ici la fin de 2024.
L'étude a impliqué 21 volontaires en bonne santé âgés de 45 à 80 ans selon un design en croix randomisé à deux voies. Si elle est approuvée, SCP-111 pourrait fournir une alternative à l'infusette FUROSCIX, offrant ainsi potentiellement plus de flexibilité au traitement pour les cardiologues et les patients souffrant d'insuffisance cardiaque.
scPharmaceuticals Inc. (SCPH) gab positive Ergebnisse aus einer pharmakokinetischen Studie zu SCP-111, einem experimentellen Furosemid-Autoinjektor, bekannt. Die Studie erreichte ihre primären und sekundären Endpunkte und zeigte eine 107,3%ige Bioverfügbarkeit im Vergleich zu IV-Furosemid. SCP-111 wies eine ähnliche Urinproduktion und Elektrolytausscheidung wie IV-Furosemid auf, wobei an den Injektionsstellen nur minimale Schmerzen gemeldet wurden. Das Unternehmen plant, bis Ende 2024 einen Zusätzlichen Neuen Arzneimittelantrag (sNDA) bei der FDA einzureichen.
Die Studie umfasste 21 gesunde Freiwillige im Alter von 45 bis 80 Jahren in einem randomisierten, zweifach über Kreuz durchgeführten Design. Sollte es genehmigt werden, könnte SCP-111 eine Alternative zum aktuellen FUROSCIX tragbaren Infusor bieten, was möglicherweise eine größere Behandlungsspielraum für Kardiologen und Herzinsuffizienzpatienten bieten könnte.
- SCP-111 achieved 107.3% bioavailability compared to IV furosemide, meeting the primary endpoint
- Similar urine output and electrolyte excretion to IV furosemide at 6, 8, and 12 hours
- Minimal pain reported at injection sites with a median pain score of 0
- On track for sNDA submission to FDA by year-end 2024
- Adverse events reported, primarily localized to the injection site
The positive topline results for SCP-111 are promising for scPharmaceuticals. The study achieved its primary pharmacokinetic endpoint with a bioavailability of
The pharmacodynamic results, showing similar urine output and electrolyte excretion, further support the efficacy of SCP-111. The median pain score of 0 is particularly noteworthy, indicating excellent tolerability. This could be a significant advantage over current IV administration methods, potentially improving patient comfort and compliance.
However, investors should note that this is an early-stage study with a small sample size of 21 subjects. While promising, larger trials will be necessary to confirm these results and assess long-term safety profiles.
This news is potentially significant for scPharmaceuticals' future revenue streams. If approved, the SCP-111 autoinjector could expand the market for FUROSCIX by offering a more convenient administration option. This could lead to increased adoption among both healthcare providers and patients.
The company's plan to submit a Supplemental New Drug Application (sNDA) by year-end 2024 suggests a relatively quick path to potential commercialization. However, investors should be aware that FDA approval is not guaranteed and the timeline for potential revenue impact extends into 2025 and beyond.
While this development is positive, it's important to consider the company's current financial position and burn rate. The costs associated with further development and potential commercialization of SCP-111 should be weighed against projected revenues. Investors should closely monitor upcoming financial reports for insights into the company's cash position and funding needs.
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
BURLINGTON, Mass., Aug. 12, 2024 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH) (the “Company”), 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 topline results from the pharmacokinetic (PK) study of SCP-111, an investigational, low volume, pH neutral formulation of furosemide administered via an autoinjector as an alternative to the current on-body infusor used with FUROSCIX.
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 the90% 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 John Tucker, Chief Executive Officer of scPharmaceuticals. “If approved, we believe administration of furosemide via an autoinjector would provide treatment flexibility to cardiologists and heart failure specialists and their patients.”
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 Burlington, MA. For more information, please visit www.scPharmaceuticals.com.
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 December 31, 2023 on file with the Securities and Exchange Commission, available at the Securities and Exchange Commission’s website at www.sec.gov, as well as discussions of potential risks, uncertainties and other important factors in the Company’s subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information unless required by law.
Katherine Miranda
scPharmaceuticals Inc., 781-301-6869
kmiranda@scpharma.com
Investors:
PJ Kelleher
LifeSci Advisors, 617-430-7579
pkelleher@lifesciadvisors.com
FAQ
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