-- Antibacterial coverage (time over MIC) equivalent to coverage following standard intravenous administration.
-- Novel route of administration is free from common and serious risks associated with intravenous infusion lines and deep intramuscular injections.
LEXINGTON, Mass., March 2, 2016 /PRNewswire/ -- scPharmaceuticals, Inc., announced today that the pivotal trial for its ceftriaxone program met the targeted end-points. The primary end-point for the study is non-inferior antimicrobial coverage when compared to the same dose given by intravenous infusion. Antimicrobial coverage refers to time over the Minimum Inhibitory Concentration (MIC), a generally accepted measure of the adequacy of plasma levels of an antibiotic for treatment of infections due to susceptible bacteria.
"This represents an important milestone in our quest to make widely-used antibiotics available without the risks, discomfort and costs associated with infusion lines that are routinely required for longer courses of ceftriaxone treatment," said Pieter Muntendam, M.D., President and CEO of scPharmaceuticals. "These results indicate that antimicrobial coverage following subcutaneous administration of ceftriaxone is fully comparable to antimicrobial coverage following standard intravenous administration."
The three-way, cross-over study compared one gram administered subcutaneously over two hours with one gram administered intravenously over 30 minutes and included a third treatment involving subcutaneous administration of two grams of ceftriaxone. The study was conducted in the US under the company's investigational new drug (IND) application. The pivotal clinical study is part of a development program for which the company sought and received input from the FDA through in-person meetings and correspondence.
"Technologies that eliminate the need for long-term IV catheters will greatly improve patient safety, preventing bloodstream infections, and reducing other complications and cost of healthcare. In a 2013 New England Journal of Medicine article, Dave Gilbert, John Bartlett, and I called for Novel drug-delivery systems to replace IV catheters to achieve this goal," said Brad Spellberg, M.D., Professor of Clinical Medicine, Keck School of Medicine at the University of Southern California. "The ability to achieve similar blood levels by administration of antibiotics subcutaneously makes the goal of eliminating long-term IV catheters a reality for many patients. This is extremely exciting and important for the health and welfare of our patients."
scPharmaceuticals reports the following results:
| Mean Plasma Concentration (mcg/mL) |
||||||
| GROUP |
T2h |
T4h |
T6h |
T8h |
T12h |
T24h |
| 1G Subcutaneous |
56 |
72 |
62 |
53 |
37 |
13 |
| 2G Subcutaneous |
86 |
123 |
104 |
90 |
61 |
21 |
| 1G Intravenous |
84 |
62 |
49 |
41 |
28 |
10 |
| From Package Insert |
||||||
| 1G Intravenous |
88 |
67 |
53 |
43 |
28 |
9 |
| 1G Intramuscular |
76 |
68 |
56 |
44 |
29 |
ND |
Using a once-a-day regimen, plasma levels 12 hours following the start of administration are most relevant in determining if ceftriaxone is a suitable treatment for an infection. At the 12-hour time-point in the trial, plasma levels following subcutaneous administration were approximately 30 percent higher than observed following standard intravenous administration. This indicates that the antibacterial effect is at least equivalent to standard intravenous administration.
This study is part of scPharmaceuticals' development program for a drug-device combination product comprising ceftriaxone and the sc2Wear Ceftriaxone Pump, a proprietary patch pump for subcutaneous administration of ceftriaxone. The sc2Wear Pump is designed to enable convenient, comfortable and controlled subcutaneous administration of injectable pharmaceuticals, without the resources and costs of intravenous or intramuscular administration. Ceftriaxone and other antibiotics that require daily intravenous delivery are routinely administered by means of a peripherally inserted central catheter (PICC). A PICC, also called a PICC line, is the standard method to administer ceftriaxone and other injectable antibiotics when a course of longer duration, typically seven days or more, is indicated. PICC lines are long thin hollow catheters 25-60cm in length (10-24 inches) that are inserted in the large veins of the upper arm and advanced so that the tip is in the inlet of the heart. PICC lines remain in place for the duration of the treatment course. PICC lines are associated with rare but serious complications including irregular heartbeat, deep vein thrombosis, infection at the site of insertion or bloodstream infection. In addition to the serious complications, PICC lines are associated with more common complications, such as line occlusion and discomfort that often lead to unscheduled physician contacts. Use of the sc2Wear Pump would avoid all PICC-related complications as well as costs associated with PICC line placement, use and removal.
scPharmaceuticals anticipates submitting a 505(b)(2) NDA in the second half of 2016 for the sc2Wear Ceftriaxone drug-device combination.
Ceftriaxone was first introduced in 1984 and, as a result of its antibiotic efficacy and its convenient once-a-day administration, became one of the most widely used injectable antibiotics. In the United States alone, approximately 30 million doses of ceftriaxone are administered annually. The most common indications for ceftriaxone use are lower respiratory tract infections (pneumonia), skin infections, and bone and joint infections.
About ceftriaxone:
Ceftriaxone (INN) is an antibiotic useful for the treatment of a number of bacterial infections. Ceftriaxone was introduced by Hoffmann-La Roche in 1984 under the trade name Rocephin. Ceftriaxone belongs to the cephalosporin group of antibiotics and is classified as a third-generation cephalosporin. Ceftriaxone cannot be taken by mouth and it is currently approved for administration by intravenous infusion or intramuscular injection.
Ceftriaxone is approved to treat the following infections when caused by susceptible bacteria: lower respiratory tract infections, ear infections, skin infections, urinary tract infections, gonorrhea, pelvic inflammatory disease, septicemia, bone and joint infections, intra-abdominal infections and meningitis. It is also used preoperatively to reduce the risk of postoperative infections.
Important Information
The sc2Wear Ceftriaxone Combination Product is subject to FDA and other regulatory review and approval prior to commercial introduction and clinical use.
About scPharmaceuticals:
scPharmaceuticals, Inc., based in Lexington, MA, is a privately held biopharmaceutical company developing a portfolio of transformative pharmaceutical products for subcutaneous delivery. Our innovative products are based on widely used generic drugs that currently require intravenous or intramuscular injections. They will be administered subcutaneously via the sc2Wear Pump. This enables the avoidance of material risks and costs associated with current delivery options. Our lead products are the first subcutaneous formulation of furosemide (the most widely used parenteral diuretic in treating heart failure), and ceftriaxone (the parenteral antibiotic most widely used outside the hospital setting). Our novel furosemide formulation enables convenient anytime anywhere use, for example in an outpatient setting instead of the emergency room or other inpatient settings. For ceftriaxone and other antibiotics, subcutaneous administration eliminates the need for PICCs (peripherally inserted central catheters), which are associated with serious complications, frequent adverse events and high medical costs. The company recently announced positive results from the pivotal trial of it novel subcutaneous furosemide formulation (November 4, 2015). For further information on how we are transforming the administration of parenteral drugs, go to www.scpharmaceuticals.com.
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SOURCE scPharmaceuticals, Inc.
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