Full Press Release Details
CorMedix Inc. Reports Second Quarter Financial Results and Provides
Conference Call Scheduled for Today at 4:30 p.m. Eastern
Recent Corporate and Clinical Highlights:
key FDA-agreed changes to the LOCK-IT-100 trial designed to enhance
event capture and significantly reduced the number of events
required to complete the study
to announce advances to the taurolidine-based therapeutic and
medical device pipeline
Khan, M.D., Steven Lefkowitz, and Gary Gelbfish, M.D., to the Board
of Directors; Elected Myron Kaplan Chairman of the Board of
revenue via Hemotech stocking of distribution channels in France;
European commercialization efforts continue
reduced Neutrolin's cost of goods, providing an opportunity
to compete effectively in the U.S. and international
shareholder approval to increase the Company's authorized
share capital to 160 million common shares
Anticipated Milestones:
interim efficacy analysis, potentially in 4Q17 pending attainment
of the requisite number of catheter-related bloodstream infection
(CRBSI) events in the study
for LOCK-IT-100 by 2Q18; Report top-line data in the second half of
taurolidine-incorporated medical device pipeline through animal
proof-of-concept studies expected to be completed by yearend 2017
to support FDA submission in 2018
Bedminster, NJ August 9, 2017 CorMedix Inc.
(NYSE MKT: CRMD), a biopharmaceutical company focused on developing
and commercializing therapeutic products for the prevention and
treatment of infectious and inflammatory disease, today provided
its corporate update for the second quarter and six months ended
June 30, 2017. CorMedix will host a conference call today, August
9, 2017, at 4:30 p.m. Eastern Time, to discuss the Company's
recent corporate developments and financial results.
Baluch, Chief Executive Officer of CorMedix, said, Our
priority remains to bring Neutrolin , our
broad-spectrum, non-antibiotic anti-infective solution to the U.S.
market. We are very excited that our recent discussions with the
FDA have proven fruitful. As announced in April 2017, we sought
guidance from the FDA to address, in part, the apparent overall
lower rate of catheter-related blood stream infection (CRBSI)
events in the blinded study. This is critical because CRBSI events
represent the outcome measure for the primary efficacy endpoint of
the study. Based on the information provided for the ongoing
LOCK-IT-100 study and a revised plan that we submitted to them, the
FDA agreed to key changes to the study intended to facilitate more
comprehensive capture of CRBSI events, and therefore, our ability
to complete the ongoing Phase 3 study. We appreciate the FDA
working with us on a solution to help bring this study to a
meaningful conclusion.
key changes, as agreed to by the FDA, have already been instituted
by CorMedix, and include the use of an independent Clinical
Adjudication Committee (CAC) to critically assess all suspected
CRBSIs and determine, on a blinded, case-by-case basis, if the
particular event will be included in the primary analysis of the
primary efficacy endpoint of the study. The CAC will also base its
determination on a single positive blood culture along with
supporting documentation (as compared to two positive blood
cultures under the original protocol). Importantly, the FDA also
agreed to allow the CAC to evaluate suspected CRBSIs
retrospectively based on patient records and other documentation,
enhancing our ability to capture potential events that may have
been lost when patients went to non-participating emergency rooms
or urgent care centers with a suspected CRBSI. Finally, based on
amended study assumptions, which include a reduction in statistical
power from 90% to 80% and a moderate increase in the target
treatment effect from 40% to 55%, the total number of CRBSI events
required to complete the study was reduced from 161 events to 56
events. We expect to conduct a single interim efficacy analysis,
based upon successful capture of 28 CRBSI events, in the fourth
quarter of this year. The interim analysis may also potentially
allow CorMedix to conclude the study earlier than projected if the
interim data show sufficient Neutrolin
Baluch continued, We recently hosted an R&D Day to
showcase the exciting science on which we have been working: to
incorporate taurolidine into medical devices, and to highlight the
potential for a taurolidine-based therapy for cancer.
are especially excited about the development of taurolidine-infused
medical devices, because we anticipate pursuing approval of these
products under the 510(k) device pathway, which requires less time
and reduced development costs as compared to an NDA process for
drugs. Within potential medical devices, our efforts are focused on
three initial areas; antimicrobial surgical sutures, meshes, and
hydrogels. Upon potential FDA clearance, all three of our product
candidates will enter large markets where we believe they can
achieve significant market share and improve patient outcomes at a
minimal incremental cost. We are currently conducting
proof-of-concept studies in animal models, based on encouraging in
vitro data, and these studies are expected to complete by yearend.
If successful, we anticipate pursuing marketing applications in the
second half of 2018. We intend to commercialize our medical devices
in the U.S. and Europe through appropriate partners.
addition to medical devices, we have also been active in our
collaboration with the Pediatric Oncology Experimental Therapeutics
Investigators' Consortium, or POETIC, on preclinical development of
taurolidine-based therapies for cancer. CorMedix and POETIC are
advancing this program through preclinical studies and will
determine a potential clinical strategy once in vivo
proof-of-concept is achieved. This represents another capital
efficient strategy to explore new ways to capitalize on our
taurolidine opportunity and build future value for
Baluch added, We are pleased with the work undertaken by our