CorMedix Inc. Announces Scientific Advisory Board to Support Commercialization and Pipeline Development

Rhea-AI Summary

CorMedix Inc. (Nasdaq: CRMD) announced the formation of a new Scientific Advisory Board (SAB) on April 7, 2022. This board, composed of experts in nephrology, infectious diseases, medical nutrition, and pediatric oncology, aims to guide the development of DefenCath™, a catheter lock solution under FDA review for reducing catheter-related bloodstream infections in hemodialysis patients. The SAB will collaborate closely with CorMedix leadership as the company prepares for a potential commercial launch and seeks to expand DefenCath's applications.

Positive

• Formation of a new Scientific Advisory Board with esteemed experts to guide DefenCath development.
• DefenCath has received Fast Track designation and Qualified Infectious Disease Product status from FDA.
• Potential for additional marketing exclusivity through pediatric studies.

Negative

• Received a Complete Response Letter from FDA delaying NDA approval until manufacturing deficiencies are resolved.
• Dependence on successful FDA discussions and future financing for continued development.

BERKELEY HEIGHTS, N.J., April 07, 2022 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, today announced the formation of a new Scientific Advisory Board (SAB) comprised of esteemed experts in nephrology, infectious disease, medical nutrition, and pediatric oncology. The SAB’s mission will be to provide strategic and scientific advice as CorMedix advances DefenCath™ toward a potential commercial launch and looks to pursue DefenCath lifecycle expansion opportunities.

DefenCath is being developed as a catheter lock solution with an initial indication of use currently under review by the U.S. Food and Drug Administration (FDA) for the reduction of catheter-related bloodstream infections (CRBSIs) in patients with renal failure who are receiving chronic hemodialysis via a central venous catheter. CorMedix is focused on preparing for a potential commercial launch in hemodialysis and aims to explore the safety and effectiveness of DefenCath in other potential patient populations with central venous catheters. The SAB members will work closely with CorMedix leadership as the Company evolves the development of DefenCath.

“We are excited and privileged to have the opportunity to work with this highly accomplished group of thought leaders who are experts in their respective areas. Their knowledge of the many challenges faced by patients and clinicians when preventing and treating life-threatening infections is clearly an asset to CorMedix,” said Liz Hurlburt, EVP and Head, Clinical Operations at CorMedix. “We expect that the SAB will play an important role in helping to inform and guide our development activities as we seek to bring DefenCath to patients.”

Dr. Matt David, CorMedix interim CEO, commented, “We are very pleased to welcome such an experienced group of clinicians as members of our SAB. The CorMedix team looks forward to working with them as we aim to explore the potential of DefenCath in patients with central venous catheters, who may benefit from its use.”

Scientific Advisory Board Members:

Saravanan Balamuthusamy, M.D., FASN, FASDIN. Nephrologist, PPG Healthcare, Chairman, Division of Internal Medicine, Medical College of Ft. Worth

Sara Bonnes, M.D., M.S., FACP. Associate Professor of Medicine, Physician Nutrition Specialist, Mayo Clinic

Stanley Crittenden, M.D., FASN. Nephrologist, Chief Medical Officer, Evergreen Nephrology

Aru Narendran, M.D., Ph.D., FAAP. Professor of Pediatrics, Oncology, Biochemistry, and Molecular Biology, Physiology and Pharmacology, Cumming School of Medicine, University of Calgary

Hannah Newman, MPH, CIC. Director of Infection Prevention, Northwell Health

Bruce Polsky, M.D., MACP, FIDSA. Professor and Chairman, Department of Medicine, Associate Dean, Faculty, NYU Long Island School of Medicine

Prayus Tailor, M.D., FASN. Nephrologist, Nephrology Associates, PA and Medical Director, Fresenius Medical Care, North America

Jonathan Waitman, M.D. Assistant Professor in Medicine, Medical Director of Specialized Nutrition Support, Weill Cornell Medical College

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 DefenCath™, a novel, antibacterial and antifungal solution designed to prevent costly and life-threatening bloodstream infections associated with the use of central venous catheters in patients undergoing chronic hemodialysis. DefenCath has been designated by FDA as Fast Track and as a Qualified Infectious Disease Product (QIDP), and the original New Drug Application (NDA) received priority review in recognition of its potential to address an unmet medical need. QIDP provides for an additional five years of marketing exclusivity, which will be added to the five years granted to a New Chemical Entity upon approval of the NDA. CorMedix also committed to conducting a clinical study in pediatric patients using a central venous catheter for hemodialysis when the NDA is approved, which will add an additional six months of marketing exclusivity when the study is completed. The company received a Complete Response Letter from FDA stating that the original NDA could not be approved until deficiencies at the contract manufacturing facility were satisfactorily resolved and we believe the deficiencies have been addressed in the resubmitted NDA that has been accepted for filing by FDA. CorMedix also intends to develop DefenCath as a catheter lock solution for use in other patient populations. It is leveraging its taurolidine technology to develop a pipeline of antimicrobial medical devices, with 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. Neutrolin® is CE Marked and marketed in Europe and other territories as a medical device. 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 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 results of our discussions with the FDA regarding the DefenCath development path for marketing authorization; the resources needed to secure approval of the new drug application for DefenCath from the FDA; our ability to address the deficiencies identified at our CMO in connection with the manufacture of DefenCath; 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 DefenCath/Neutrolin and research for additional uses for taurolidine; obtaining additional financing to support CorMedix’s research and development and clinical activities and operations; preclinical results are not 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. We continue to assess to what extent the uncertainty surrounding the Coronavirus pandemic may impact our business and operations. 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) 430-7576

FAQ

What is the purpose of CorMedix's new Scientific Advisory Board?

The SAB's mission is to provide strategic and scientific advice to guide the development of DefenCath as CorMedix prepares for a potential commercial launch.

What product is DefenCath designed to prevent infections for?

DefenCath is developed to reduce catheter-related bloodstream infections in patients receiving hemodialysis via central venous catheters.

What recognition has DefenCath received from the FDA?

DefenCath has been designated as a Fast Track product and a Qualified Infectious Disease Product (QIDP), enhancing its potential market exclusivity.

What challenges does CorMedix face regarding DefenCath's approval?

CorMedix needs to address deficiencies identified at its contract manufacturing facility before the FDA will approve its new drug application.

How will the new Scientific Advisory Board impact CorMedix?

The SAB is expected to inform and guide CorMedix's development activities, enhancing the strategy for bringing DefenCath to market.