Citius Pharmaceuticals Achieves Next Interim Analysis Milestone in its Mino-Lok® Phase 3 Trial

 

Source: Citius Pharmaceuticals, Inc. 6/8/2021

- Independent Data Monitoring Committee (DMC) to review Mino-Lok® safety, superiority, and futility data at upcoming meeting scheduled for June 29, 2021-

Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products with a focus on anti-infective products in adjunct cancer care, unique prescription products and stem cell therapy, today announced that the next planned interim analysis in its Phase 3 trial of Mino-Lok^®, an antibiotic lock solution for the treatment of patients with catheter-related blood stream infections (CRBSIs/CLABSIs) has been scheduled for the end of June 2021.  In accordance with the independent Data Monitoring Committee (DMC) charter, the DMC will hold a meeting to review the trial data for safety, superiority and futility. 

"We look forward to feedback from the DMC following their review of the trial data," stated Myron Holubiak, President and Chief Executive Officer of Citius.

According to the Mino-Lok^® Phase 3 study protocol, the DMC is responsible for conducting interim analyses when 40%, 50% and 65% of the total number of anticipated events have been observed.  The first two interim analyses were conducted by the DMC in 2019 and 2020, respectively.  The next interim analysis meeting of the DMC will be held on June 29, 2021.  At that time, the DMC will review unblinded study data and subsequently provide written recommendations to Citius within five business days.

The Mino-Lok^® Phase 3 pivotal superiority trial is a multi-center, randomized, open-label, blinded study to determine the efficacy and safety of Mino-Lok^® (MLT), a novel antibiotic lock therapy that combines minocycline with edetate disodium. The primary endpoint for this study is the time (in days following randomization) to a catheter failure event between randomization and TOC (Week 6) in the Intent-to-Treat (ITT) Population.

Approximately 144 subjects diagnosed with CRBSI/CLABSI and who meet all necessary criteria for the study are randomized in a 1:1 ratio to receive either Mino-Lok^® therapy or standard of care antibiotic lock therapy. To date, the Company has achieved more than 80% of the expected enrollment.

Subjects in the Mino-Lok^® arm receive one MLT dose daily with a dwell time of two to four hours for a total of seven doses. For subjects in the Control arm, the investigator determines the antibiotic used in the lock, dose, dwell time, and number of days of administration based on institutional standards or Infectious Diseases Society of America (IDSA) guidelines.

About Mino-Lok^®
Citius is developing Mino-Lok^®, an antibiotic lock solution to treat patients with catheter-related blood stream infections that was licensed from The University of Texas MD Anderson Cancer Center.  Citius believes Mino-Lok^® provides a superior alternative to removing and replacing a central venous catheter (CVC), leading to a reduction in serious adverse events and cost savings to the healthcare system. A multicenter Phase 3 pivotal superiority trial is currently underway. If approved, Mino-Lok^® would be the first and only FDA-approved treatment that salvages central venous catheters that cause central line-related blood stream infections.

About Citius Pharmaceuticals, Inc.
Citius is a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, with a focus on anti-infectives in adjunct cancer care, unique prescription products, and stem cell therapy. The Company's lead product candidate, Mino-Lok^®, an antibiotic lock solution for the treatment of patients with catheter-related bloodstream infections (CRBSIs), is currently enrolling patients in a Phase 3 pivotal superiority trial.  Mino-Lok® was granted Fast Track designation by the U.S. Food and Drug Administration (FDA). Through its subsidiary, NoveCite, Inc., Citius is developing a novel proprietary mesenchymal stem cell treatment derived from induced pluripotent stem cells (iPSCs) for acute respiratory conditions, with a near-term focus on Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19.  For more information, please visit www.citiuspharma.com.