scPharmaceuticals Announces Data Presentations at the Heart Failure Society of America 2022 Annual Scientific Meeting

Rhea-AI Summary

scPharmaceuticals Inc. (Nasdaq: SCPH) announced two poster presentations at the Heart Failure Society of America (HFSA) 2022 Annual Meeting, highlighting the clinical benefits of FUROSCIX® (furosemide injection) in treating heart failure congestion at home. Data from a pilot study showed that patients using FUROSCIX experienced significantly greater weight reduction and improved dyspnea scores compared to those on oral diuretics. The company anticipates a robust launch for FUROSCIX following its October 8 PDUFA date, pending FDA approval.

Positive

• Pilot study indicated FUROSCIX led to a greater weight reduction (2.8 kg vs 0.8 kg, p=0.035).
• Significantly improved dyspnea scores for FUROSCIX users (-0.5 vs 0.1, p=0.019).
• 44% of FUROSCIX patients reported improved shortness of breath at day 3 compared to 6% on oral diuretics (p=0.006).
• Quality of life scores improved by 8.9 points and 9.3 points at days 7 and 30.
• Patients experienced a 55.8-meter increase in 6-minute walk distance (p=0.012).
• 14.7% of FUROSCIX subjects had manageable potassium levels during the study.

Negative

• 14.7% of subjects experienced low potassium levels, requiring supplementation.

Presentations highlight the significant potential clinical benefits of managing congestion in patients with heart failure with FUROSCIX® (furosemide injection) at home

BURLINGTON, Mass., Sept. 30, 2022 (GLOBE NEWSWIRE) -- 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 two poster presentations, including a late breaker, at the Heart Failure Society of America (HFSA) 2022 Annual Meeting, which is being held September 30 – October 3, in Washington DC.

“We are very pleased to have an opportunity to present scientific data at this year’s HFSA Annual Scientific Meeting, which is among the most important and well attended gatherings of heart failure experts each year,” stated John Tucker, chief executive officer of scPharmaceuticals. “The two presentations highlight the significant potential benefits – both to patients and payers – of an alternative approach to the management of congestion in patients with heart failure outside of the hospital. We believe FUROSCIX (furosemide injection), if approved, represents a potential new model for the treatment of congestion in patients with heart failure by allowing IV-equivalent diuresis at home, thus potentially reducing costly hospital admissions and readmissions.”

“We are eagerly approaching our October 8 FUROSCIX PDUFA target action date, and, assuming FDA approval, are well prepared to initiate a robust commercial launch of FUROSCIX in 2022,” Mr. Tucker concluded.

Details of the presentations are as follows:

Title:	Avoiding Treatment in Hospital with FUROSCIX to Manage Congestion in Heart Failure (AT HOME-HF) – A Pilot Study
Poster #:	LBA-007 (late breaking)
Session:	General Poster Viewing Session II
Date:	Saturday, October 1, 2022
Time:	12:45pm – 1:00pm EDT
Location:	Exhibit Hall ePoster Hub
Summary:	This poster describes the results of a Phase 2, multicenter, pilot study where 51 subjects presenting to a heart failure clinic with worsening congestion requiring augmented diuresis were randomized (2:1) to receive FUROSCIX or enhanced oral diuretics.

Subjects who received FUROSCIX demonstrated augmented decongestion compared with patients receiving enhanced oral diuretics as demonstrated by:

• Improved diuresis as measured by a greater reduction in body weight from baseline at study day 3 (2.8 kg vs 0.8 kg, p=0.035);
• Improvement from baseline in mean 5-point dyspnea score at day 3 (-0.5 vs. 0.1, p=0.019);
• Greater number of patients with markedly or moderately better shortness of breath based on 7-point dyspnea at day 3 (44% vs 6%, p=0.006);
• Clinically relevant improvement from baseline in quality of life as measured by Kansas City Cardiomyopathy questionnaire – 12 (KCCQ-12) summary score at study days 7 and 30 of 8.9 points and 9.3 points, respectively; and
• An increase of 55.8 meters in the average six-minute walk distance at day 30 (36.7 vs -19.1 meters, p=.012).
  

The win-ratio for the hierarchical endpoint of cardiovascular death, heart failure hospitalization, urgent ED/clinic visit for heart failure and the percentage change in NT-proBNP from baseline at day seven was 1.11 (95% Confidence Interval: 0.48-2.50) favoring the FUROSCIX group.

During the 30-day study period, subjects in the FUROSCIX group spent an average of 23.2 days heart failure event free compared to 14.3 in subjects receiving enhanced oral diuretics.

In the FUROSCIX group, 14.7% of subjects had a serum potassium level that was less than 3.5 mEq/L during the 30-day study and was managed effectively with oral potassium supplements.

Conclusion: Subjects receiving subcutaneous FUROSCIX demonstrated augmented decongestion as evidenced by a greater reduction in body weight, better dyspnea scores, greater exercise capacity and improvement of health-related quality of life compared with patients receiving enhanced oral diuretics, or standard treatment in a phase 2, pilot study. The favorable results in the AT HOME-HF Pilot Study support conducting an adequately powered study.

Title:	Acute Decompensated Heart Failure: Examining Those with Brief Hospitalizations
Poster #:	291
Session:	General Poster Viewing Session IV
Date:	Sunday, October 2, 2022
Time:	12:30pm – 12:45pm EDT
Location:	Exhibit Hall ePoster Hub
Summary:	This poster describes a study that investigated the volume, length of stay (LOS) and patient characteristics of patients hospitalized for acute decompensated heart failure (ADHF) in the US using the multicenter National Inpatient Sample (NIS) representing approximately 20% of US acute care hospitals. Of the approximately 5 million discharges with any heart failure diagnosis code, 1.2 million patients had heart failure as the principal diagnosis code and approximately 43% of such patients had a LOS of less than 3 days (SLOS) with the average LOS being 2.2 days. Compared to patients with LOS greater than 3 days (LLOS), SLOS patients were less likely to require mechanical ventilation (2.8% vs 0.7%), dialysis (2.9% vs 0.4%) and undergo diagnostic procedures (70.4% vs 48.4%). SLOS patients were more likely to have a routine discharge to home (61.8% vs 39.7%)

Conclusion: An alternative outpatient heart failure management may allow many patients to avoid the need for short hospitalizations with its potential complications and healthcare costs.

About FUROSCIX® (furosemide injection) 80 mg/10mL for subcutaneous use

FUROSCIX is an investigational, proprietary furosemide solution formulated to a neutral pH, designed to allow for subcutaneous infusion via a wearable, pre-programmed on-body drug delivery system, for outpatient self-administration. FUROSCIX is currently under development for the treatment of congestion due to fluid overload in adult patients with New York Heart Association (NYHA) Class II and Class III chronic heart failure who display reduced responsiveness to oral diuretics and who do not require hospitalization. If approved, FUROSCIX has the potential to provide an outpatient alternative for the treatment of worsening heart failure due to congestion.

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 Statements

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 significance and potential impact of the results of the AT HOME-HF clinical trial and the clinical data; the interpretation and analyses of the results from the AT HOME-HF clinical trial; statements regarding the timing and outcome of the FDA’s review of the FUROSCIX NDA; expectations regarding the potential label or market impact of FUROSCIX, if approved; the preparation and timing of commercial launch and the success of such commercialization, if approved; and the potential benefits, expected costs and future plans and expectations for FUROSCIX, if approved. 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 risk that results of a clinical study do not necessarily predict final results and that one or more of the clinical outcomes may materially change following more comprehensive reviews of the data, and as more patient data become available, the risk that results of a clinical study are subject to interpretation and additional analyses may be needed and/or may contradict such results, the risk of the ability of the FUROSCIX On-Body Infusor to appropriately deliver therapy, the receipt of regulatory approval for the FUROSCIX On-Body Infusor or any of our other product candidates or, if approved, the successful commercialization of such products, the risk of cessation or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, the risk that the results of previously conducted studies will not be repeated or observed in ongoing or future studies involving our product candidates, and the risk that the current COVID-19 pandemic will impact the Company’s device validation, drug stability testing, and other operations. 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 section entitled “Risk Factors” in Company’s Annual Report on Form 10-K for the year ended December 31, 2021 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 Taudvin
scPharmaceuticals Inc., 781-301-6706
ktaudvin@scpharma.com

Investors:
Hans Vitzthum
LifeSci Advisors, 617-430-7578
hans@lifesciadvisors.com 

FAQ

What were the key findings from the scPharmaceuticals FUROSCIX pilot study?

The pilot study found that FUROSCIX resulted in greater weight loss and improved dyspnea scores compared to oral diuretics.

When is the PDUFA date for FUROSCIX?

The PDUFA target action date for FUROSCIX is October 8, 2022.

What is the significance of the FUROSCIX presentations at the HFSA Annual Meeting?

The presentations highlighted the potential benefits of using FUROSCIX for managing heart failure congestion at home.

How does FUROSCIX compare to traditional diuretics in heart failure treatment?

FUROSCIX showed better outcomes in weight reduction and dyspnea relief compared to enhanced oral diuretics.

What is scPharmaceuticals' focus in the pharmaceutical industry?

scPharmaceuticals is focused on developing products that optimize infused therapies and improve patient care while reducing healthcare costs.