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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: Statement of Changes in Beneficial Ownership (4) 08/16/2018 04:10:44 PM
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PostSubject
#833  Sticky Note 7/25/18 News - Cormedix Inc. Announces Positive Results dshade 08/02/18 10:47:45 AM
#1038   Agree. It's a shame what they are Lazerking40 08/21/18 12:02:12 PM
#1037   taking it all the way back to pre dshade 08/21/18 10:37:18 AM
#1036   carried forward tax is an advantage now as well. dshade 08/21/18 08:49:08 AM
#1035   Orangecat - you packed a lot in there. Lazerking40 08/21/18 07:27:53 AM
#1034   Like CRMD, that other company I mentioned received orangecat 08/20/18 09:47:15 AM
#1033   I think I saw what you are referring Lazerking40 08/20/18 07:26:21 AM
#1032   Any idea when we might hear back from Rapture2020 08/19/18 07:26:51 PM
#1031   I don't remember if it was this board orangecat 08/19/18 08:39:57 AM
#1030   My bad. I thought they were on a orangecat 08/18/18 09:24:41 PM
#1029   What are you all thinking the June 2.50 orangecat 08/18/18 09:17:05 PM
#1028   Updated Investor Presentation on CRMD website: http://www.cormedix.com/wp-cont Idunno 08/18/18 04:59:43 PM
#1027   You're probably right it may have been 20 Chappy86 08/17/18 02:14:33 PM
#1026   You’d have to have seen 200 of the Rapture2020 08/17/18 02:12:13 PM
#1025   I thought they were 5,000 shares lots. Chappy86 08/17/18 01:44:02 PM
#1024   5000 or 50000? Rapture2020 08/17/18 01:43:20 PM
#1023   Thanks I couldn't believe all the 5000 flashing Chappy86 08/17/18 01:11:18 PM
#1022   When I get home tonight I’ll pull today’s Rapture2020 08/17/18 01:08:32 PM
#1021   OK thank you Chappy86 08/17/18 01:07:25 PM
#1020   Well for the record I counted 14 5000 Chappy86 08/17/18 01:04:36 PM
#1019   I watched it on the I Hub trades Chappy86 08/17/18 01:03:30 PM
#1018   Just saw volume only 1.3M so I doubt it. Rapture2020 08/17/18 01:02:29 PM
#1017   How can that be verified? Rapture2020 08/17/18 01:01:43 PM
#1016   Didn't somebody buy over a million shares @.47 Chappy86 08/17/18 12:37:54 PM
#1015   Yeah, that strike price is a little higher Rapture2020 08/17/18 08:57:26 AM
#1014   This March calls were really cheap and if Lazerking40 08/17/18 08:56:41 AM
#1013   Right. Time will tell, lol. I’m thinking/hoping with Idunno 08/17/18 08:46:24 AM
#1012   Got it; and thank you both. I hope Rapture2020 08/17/18 08:25:52 AM
#1011   I hope those calls work out for you Lazerking40 08/17/18 07:39:50 AM
#1010   Rapture, I know you asked Lazer, forgive me Idunno 08/17/18 03:54:12 AM
#1009   Lazer, I am the proud papa of gobs Rapture2020 08/16/18 11:00:32 PM
#1008   agreed dshade 08/16/18 02:51:31 PM
#1007   Fascinating, .459 Bid / .4591 Ask. Well, whatever Idunno 08/16/18 02:18:00 PM
#1006   Sorry, it may actually be NASR and NSDQ. Rapture2020 08/16/18 10:51:53 AM
#1005   ARCA and AMEX are back on the Ask Rapture2020 08/16/18 10:50:12 AM
#1004   Nice summary! Chappy86 08/16/18 09:32:59 AM
#1003   Timeline was very clear in the conference call: Aug Lazerking40 08/16/18 08:54:50 AM
#1002   Thanks Lazerking. Obviously anything can happen, but, given Idunno 08/15/18 01:44:03 PM
#1001   Good luck to you and your additional shares. Lazerking40 08/15/18 01:34:43 PM
#1000   I agree, too. And I doubled up today. Idunno 08/15/18 01:20:14 PM
#999   I agree. Lazerking40 08/15/18 01:16:32 PM
#998   someone wants to steal this Co and using dshade 08/15/18 12:44:27 PM
#997   Thanks for sharing your thoughts with respect to Rapture2020 08/15/18 12:33:35 PM
#996   I've been quiet lately cause I've been traveling Lazerking40 08/15/18 09:41:43 AM
#995   Well, I’m adding. Fingers crossed. Idunno 08/15/18 09:33:55 AM
#994   "we will be very open and in some dshade 08/15/18 08:53:29 AM
#993   "we believe we have the resources to fund dshade 08/15/18 08:49:38 AM
#992   They are waaay too confident! :-) They know they Rapture2020 08/15/18 08:48:32 AM
#991   Neutrolin has both fast track and QIDP status. dshade 08/15/18 08:47:57 AM
#990   "..the unblinded data for our Phase 3 LOCK-IT-100 dshade 08/15/18 08:40:56 AM
#989   Since you’re all asleep, I’ll keep running the Idunno 08/15/18 01:21:28 AM
PostSubject