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Neutrolin® granted FDA Fast Track status and is designated as a Qualified Infectious Disease Product

Harnessing taurolidine technology for the prevention and treatment of infectious, inflammatory, and other serious diseases

Neutrolin® a novel, non-antibiotic antimicrobial solution in Phase 3 development for the prevention of costly and dangerous bloodstream infections associated with the use of central venous catheters

Neutrolin® granted FDA Fast Track status and is designated as a Qualified Infectious Disease Product

Harnessing taurolidine technology for the prevention and treatment of infectious, inflammatory, and other serious diseases

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CorMedix Inc. is a commercial-stage pharmaceutical company focused on harnessing its taurolidine technology for the prevention and treatment of infectious, inflammatory, and other serious diseases.

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© 2016 CorMedix Inc. All rights reserved.

400 Connell Drive, 5th Floor
Suite 5000
Berkeley Heights, NJ 07922




CorMedix Inc. is a pharmaceutical company that develops and seeks to commercialize therapeutic products for the treatment of cardiac and renal dysfunction, also known as Cardiorenal disease. Specifically, our goal is to treat kidney disease by reducing the commonly associated cardiovascular and metabolic complications - in effect, "Treating the kidney to treat the heart.

Our therapeutic candidates for cardiorenal disease may be small molecules, biologicals, devices and/or diagnostics (tests) that enable therapy.
 

Cormedix Inc. Announces Positive Results Of Its Neutrolin(R) Phase 3 Lock-It-100 Study Based On Recommendation By Independent Data Safety Monitoring Board

News Provided by Accesswire2018-07-25
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MAJOR DEVELOPMENTS

Statistical Significance Achieved at Interim Analysis

BERKELEY HEIGHTS, NJ / ACCESSWIRE / July 25, 2018 / CorMedix Inc. (NYSE American: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, today announced that the independent Data Safety Monitoring Board (DSMB) has completed its review of the interim analysis of the data from the currently ongoing Phase 3 LOCK-IT-100 study for Neutrolin®. Because the pre-specified level of statistical significance was reached and efficacy had been demonstrated, the DSMB recommended the study be terminated early. No safety concerns were reported by the DSMB based on the interim analysis. The company will submit the results of the interim analysis to the U.S. Food and Drug Administration for its review.

"We are thrilled to have received the DSMB's recommendation that efficacy has been demonstrated. Once we have submitted the interim analysis results and DSMB's recommendation to the FDA, we will begin the dialogue on the appropriate next steps," said Khoso Baluch, Chief Executive Officer of CorMedix. "We have invested a significant amount of the Company's resources over the last 2 ½ years in this study, and it is gratifying to have achieved this result based on the interim analysis. We believe Neutrolin has great potential to save lives of patients receiving hemodialysis therapy as a treatment for end-stage renal disease and to lower overall healthcare costs due to reducing the risk of catheter-related blood stream infections (CRBSI)."

The primary endpoint of the Phase 3 LOCK-IT-100 study is reducing the risk of occurrence of CRBSI by Neutrolin relative to the active control of heparin. The secondary endpoints are catheter patency, which is defined as required use of tissue plasminogen activating factor (tPA) or removal of catheter due to dysfunction, and catheter removal for any reason.

About CorMedix

CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases. The Company is focused on developing its lead product Neutrolin®, a novel, non-antibiotic antimicrobial solution designed to prevent costly and dangerous bloodstream infections associated with the use of central venous catheters, in a Phase 3 clinical trial enrolling patients undergoing chronic hemodialysis that will be terminated early for efficacy. Such infections cost the U.S. healthcare system approximately $6 billion annually and contribute significantly to increased morbidity and mortality. Neutrolin has FDA Fast Track status and is designated as a Qualified Infectious Disease Product, which provides the potential for priority review of a marketing application by FDA and allows for 5 additional years of QIDP market exclusivity in the event of U.S. approval. Neutrolin is already marketed as a CE Marked product in Europe and other territories. In parallel, CorMedix is leveraging its taurolidine technology to develop a pipeline of antimicrobial medical devices, with active programs in surgical sutures and meshes, and topical hydrogels. The company is also working with top-tier researchers to develop taurolidine-based therapies for rare pediatric cancers. For more information, visit: www.cormedix.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including with respect to the LOCK-IT-100 trial, that are subject to risks and uncertainties. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or CorMedix's prospects, future financial position, financing plans, future revenues and projected costs should be considered forward-looking. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, including: the resources needed to terminate the Phase 3 trial and the costs and time needed to submit a new drug application to the FDA; risks related to obtaining FDA approval of the new drug application for Neutrolin; the risks and uncertainties associated with CorMedix's ability to manage its limited cash resources and the impact on current, planned or future research, including the continued development of Neutrolin and research for additional uses for taurolidine; obtaining additional financing to support CorMedix's research and development and clinical activities and operations; relying on preclinical results that may not be indicative of success in clinical trials and might not be replicated in any subsequent studies or trials; and the ability to retain and hire necessary personnel to staff our operations appropriately. These and other risks are described in greater detail in CorMedix's filings with the SEC, copies of which are available free of charge at the SEC's website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.

Investor Contact:

Dan Ferry
Managing Director
LifeSci Advisors
617-535-7746

SOURCE: CorMedix, Inc.

 

© 2018 Accesswire. All Rights Reserved.

Listen to what key opinion leaders have to say.
 
Click here  to listen to what a key opinion leader has to say about contrast induced acute kidney injury and the role catalytic iron and oxidative stress play in cardiovascular disease:
CormedixPeter McCullough, MD, MPH Consultant Cardiologist, Chief Academic and Scientific Officer with St. John Providence CormedixHealth System

Click here to listen to what a key opinion leader has to say about chronic kidney disease and catalytic iron:
CormedixSudir Shah, MD, Professor of Medicine, Director of Nephrology University of Arkansas College of Medicine, Little CormedixRock, AR

Click here to listen to a key opinion leader commenting on catheter related bloodstream infections, how they affect the dialysis patient population and current treatments available:
CormedixMichael Allon, MD, University of Alabama Birmingham, Birmingham Alabama

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CRMD News: Current Report Filing (8-k) 09:26 AM
CRMD News: Statement of Changes in Beneficial Ownership (4) 03/20/2019 04:23:14 PM
CRMD News: Annual Report (10-k) 03/14/2019 04:47:54 PM
CRMD News: Current Report Filing (8-k) 03/14/2019 04:21:36 PM
CRMD News: Statement of Changes in Beneficial Ownership (4) 03/04/2019 04:09:32 PM
News News Alert: Current Report Filing (8-k) 03/21/2019 09:26:41 AM
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#833  Sticky Note 7/25/18 News - Cormedix Inc. Announces Positive Results dshade 08/02/18 10:47:45 AM
#2037   new member https://www.morganlewis.com/bios/pmounts axelvento 03/21/19 08:56:41 AM
#2036   CorMedix Inc. Announces Appointment of Phoebe Mounts as Rapture2020 03/21/19 08:45:01 AM
#2035   Summary of the CRMD Roth presentation and discussions : axelvento 03/21/19 01:54:16 AM
#2034   JANEY https://www.sec.gov/Archives/edgar/data/1410098/000165495419002991/xslF345 axelvento 03/21/19 01:40:36 AM
#2033   "Summary of the CRMD Roth presentation and discussions" H2004 03/20/19 09:45:28 PM
#2031   Hello all, morserep 03/20/19 04:18:52 PM
#2030   From the earnings. Vandalayind 03/20/19 08:57:52 AM
#2029   amen! axel, amen! i think there willl be janeyH 03/20/19 07:58:45 AM
#2028   Revenue is up, $ on hand is up, axelvento 03/20/19 02:30:42 AM
#2027   In the end Neutrolin will be approved and axelvento 03/20/19 02:21:25 AM
#2026   the r/s scares the individual. The product and axelvento 03/20/19 01:59:08 AM
#2025   now hold on there Van ... proffetti 03/19/19 05:43:07 PM
#2023   Anyone holding now is going to be reversed Vandalayind 03/19/19 04:07:15 PM
#2022   The ATM is the real reason for the Vandalayind 03/19/19 04:04:50 PM
#2021   The comedy, of course, is his use of Rapture2020 03/19/19 08:02:37 AM
#2020   It was totally unnecessary. They could have tapped Rapture2020 03/19/19 07:03:14 AM
#2019   i was surprise d by that much atm janeyH 03/19/19 06:52:59 AM
#2018   Yes. The split which is on the 26th, rawsteel 03/19/19 06:48:04 AM
#2017   The reverse split I’m guessing tone3 03/19/19 06:39:55 AM
#2016   When who pulls the trigger on what? Rapture2020 03/19/19 06:22:14 AM
#2015   Khoso goes into the books as a pretty Rapture2020 03/19/19 06:03:37 AM
#2014   As it sits now, we should be over rawsteel 03/19/19 06:00:54 AM
#2013   Pediatric neuroblastoma! axelvento 03/19/19 02:19:29 AM
#2012   usual ... As we more aggressively seek institutional interest janeyH 03/18/19 10:47:06 PM
#2011   I am sure he is referring to secondary Lazerking40 03/18/19 08:35:34 PM
#2010   what do you mean "continue to produce positive results..." voisybay123 03/18/19 07:06:58 PM
#2009   should Neutrolin continue to produce positive results and axelvento 03/18/19 12:23:09 PM
#2008   Listen to the con call. Rapture2020 03/15/19 11:34:20 PM
#2007   Okay. Bye. Great call on the PPS today. Rapture2020 03/15/19 10:17:32 PM
#2006   Nice call. Lol. Rapture2020 03/15/19 10:16:39 PM
#2005   What reason did they give for doing rawsteel 03/15/19 12:57:48 PM
#2004   buyers outnumber sellers this morning, good sign proffetti 03/15/19 09:46:35 AM
#2003   thank you yesterdays after market buyer proffetti 03/15/19 09:20:46 AM
#2002   not that bad of R/S if revs continue trajectory dshade 03/15/19 09:04:08 AM
#2001   It will fly post R/S imo TradeNaked 03/15/19 08:07:17 AM
#2000   now you have 2000 shares (as of March voisybay123 03/15/19 07:45:41 AM
#1999   CRMD buy 1.8000 stocktrademan 03/14/19 08:55:33 PM
#1998   Rap...You and I bare the scars of a H2004 03/14/19 06:29:10 PM
#1997   Hell Yes! I believe she just had her Rapture2020 03/14/19 05:54:11 PM
#1996   160M not bad. Thanks tone3 03/14/19 04:53:55 PM
#1995   M160 axelvento 03/14/19 04:49:55 PM
#1994   Do you know what the authorized shares are? tone3 03/14/19 04:42:51 PM
#1993   wonderful retest of 1.54 AGAIN! wow proffetti 03/14/19 04:41:32 PM
#1992   RS: CorMedix Inc. Reports Fourth Quarter And Full-Year axelvento 03/14/19 04:23:30 PM
#1991   substitute ‘updates’ for earnings wordsmither janeyH 03/14/19 03:06:50 PM
#1990   Earnings? Really? Not yet worried about earnings. hemopure36 03/14/19 03:05:42 PM
#1989   What amazing insight from Zach’s. janeyH 03/14/19 02:26:12 PM
#1988   No one has a clue... H2004 03/14/19 01:40:42 PM
#1987   a clearly articulated plan would go a long janeyH 03/14/19 08:42:53 AM
#1986   LoL. And back to back conferences next Monday Rapture2020 03/14/19 08:41:20 AM
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