Vancouver, Kelowna, and Delta, British Columbia--(Newsfile Corp. - July 11, 2024) - Investorideas.com, a go-to investing platform releases the second of a two-part series looking at recent news and developments in the blood infections treatment market, featuring Citius Pharmaceuticals, Inc. (NASDAQ: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products. The Company's diversified pipeline includes two late-stage product candidates.

"Bloodstream infections (BSI) are a growing threat to public health worldwide. The 2 million cases of BSIs that occur annually in North America and Europe are associated with 250,000 deaths, making BSIs the leading cause of mortality from infection", says a recent report in the Journal of Clinical Microbiology.

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Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) just announced expected milestones in the second half of calendar 2024 and recapped key achievements year-to-date.

Citius reported it has significantly advanced its two late-stage product candidates in the first six months of 2024, and expects several key milestones in the near term.

Citius recently announced positive topline data from the Phase 3 study of Mino-Lok® in catheter-related bloodstream infections (CRBSIs). Primary and secondary endpoints were met with statistical significance.

Next steps for the Mino-Lok program are to prepare a submission to the U.S. Food and Drug Administration (FDA) and schedule a Type B meeting.

Mino-Lok (MLT), a novel antibiotic lock solution that combines minocycline, ethanol and edetate disodium, is designed to treat patients with catheter-related blood stream infections. Citius licensed Mino-Lok from an affiliate of The University of Texas MD Anderson Cancer Center. Mino-Lok is designed to offer an alternative to removing and replacing a central venous catheter (CVC), which may lead to a reduction in serious adverse events and cost savings to the healthcare system. 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.

In late May, Citius announced positive topline results of its pivotal Phase 3 clinical trial of Mino-Lok®, a novel antibiotic lock solution designed to salvage catheters in patients with central line-associated infections (CLABSI) or catheter-related bloodstream infections (CRBSI). The study met its primary endpoint with a statistically significant improvement in the time to failure event in patients receiving Mino-Lok compared to Control arm patients receiving clinician-directed anti-infective lock solution. The data demonstrate that Mino-Lok is well-tolerated.

"We are extremely pleased by the strong results of the trial, which demonstrate the safety and efficacy of Mino-Lok in preserving indwelling catheters in patients with bloodstream infections. The data indicate, with a high degree of statistical significance, that Mino-Lok outperforms anti-infective lock solutions utilized in patients with CLABSI or CRBSI in the study's control arm. We believe Mino-Lok could potentially set a new standard of care (SOC) as an adjunct therapy in the treatment of patients with bloodstream infections. This therapy offers a non-invasive treatment option compared to catheter removal and replacement," stated Leonard Mazur, Chairman and Chief Executive Officer of Citius.

"We look forward to engaging with the US Food and Drug Administration (FDA) to determine the optimal path forward for Mino-Lok. Our focus remains on improving outcomes for patients and offering a much-needed alternative to the current practice of catheter removal and replacement," added Mazur.

Mino-Lok Phase 3 Trial Design

MDA 2013-0039 (NCT02901717) is a completed Phase 3 multicenter, randomized, open-label, active-controlled assessor-blinded trial conducted to evaluate the safety and efficacy of Mino-Lok as an adjunctive therapy to systemic anti-infectives for the treatment of catheter-related bloodstream infections (CRBSI) and central line-associated infections (CLABSI).

More from the news: A total of 241 patients in the U.S. and India, with an indwelling central venous catheter before the onset of a bloodstream infection, were randomized in a 1:1 ratio to receive either Mino-Lok or SOC site-specific anti-infective lock solution plus SOC systemic antibiotics. Enrollment was not limited to patients with specific types of catheters. Patients in the Mino-Lok arm received one Mino-Lok dose daily with a dwell time of two to four hours for a total of seven doses over a period of up to 15 days.

The primary endpoint for this study is the time to a catheter failure event between randomization and test of cure (TOC) at six weeks, measured in days following randomization. Additional secondary outcome measures include overall success, microbiological eradication, and clinical cure, among others.

For subjects in the Control arm, the investigator determined 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.

TOPLINE RESULTS

Efficacy:
The primary endpoint in the study was time to catheter failure between randomization and six-weeks following the first dose of Mino-Lok or SOC lock solution. Catheter failure was defined as the inability to administer study lock solution, catheter removal for any infection-related reason (including worsening clinical signs and symptoms or persistence or recurrence of baseline pathogen, or new infection), and all-cause mortality.

Results of blinded-assessor clinical outcome analyses in all randomized patients demonstrated that Mino-Lok achieved its primary endpoint:

Time to catheter failure events in patients receiving Mino-Lok therapy occurred substantially later than in patients in the Control arm (p value = 0.0006)

Median time-to-failure (MTF) of Control arm: 33 days; 95% confidence interval (CI) (14 days - 44 days; n = 122)

Median time-to-failure (MTF) of Mino-Lok arm: MTF exceeded the time the patients were on trial and therefore not estimable (NE); 95% CI (50 days - NE; n = 119)

The hazard ratio of this study was 0.53

The critical secondary endpoints included the proportion of patients at six weeks with overall treatment success including no catheter failure, clinical cure (absence of baseline clinical signs and symptoms of infection or improvement of clinical signs and symptoms such that no additional therapy was necessary), or microbiological eradication (absence of the baseline pathogen).

Results in all randomized patients who received at least one dose of study lock solution demonstrate overall treatment success in 57.1% of patients in the Mino-Lok arm and 37.7% of patients in the Control arm (p=0.0025).

Safety:
Mino-Lok is designed for intracatheter instillation and is not for intravenous injection or systemic circulation.

No serious adverse events were drug-related

Serious adverse events occurred in 45.1% of patients in the Mino-Lok arm and 46.1% of patients in the Control arm

BD (Becton, Dickinson and Company), a leading global medical technology company, today issued the following statement related to a US FDA letter to health care providers regarding the supply of blood culture vials:

From the news: Nikos Pavlidis, worldwide president of BD Diagnostic Solutions said, "BD is experiencing reduced availability of blood culture vials from our supplier. We understand the critical role that blood culture testing plays in diagnosing and treating infections and are taking all available measures to address this important issue, including providing the supplier our manufacturing expertise, using air shipments, modifying BD manufacturing schedules for rapid production, and collaborating with the U.S. Food and Drug Administration to review all potential options to mitigate delays in supply. As an additional stopgap measure, our former supplier of glass vials will restart production to help fill the intermittent gap in supply.

"We take our responsibility to support health care providers and patients very seriously and, while we are able to meet the majority of global demand, we are taking all available measures to address this important issue. BD BACTEC™ blood culture vials are being allocated manually so we can best mitigate any impact to patient care. Customers have been advised to prioritize the use of blood culture vials based on clinical needs and following guidelines, such as the most recent update from the Infectious Disease and Society of America and/or the World Health Organization.

"While this supplier issue is not expected to have a material financial impact on BD, we are fully focused on returning the supply of blood culture vials to normal levels."

CorMedix Inc., a biopharmaceutical company focused on developing therapeutic products for life-threatening diseases and conditions, recently announced that it has commenced commercialization of DefenCath® (taurolidine and heparin) to outpatient dialysis centers and vascular access clinics where patients receive outpatient dialysis and catheter placement services. The outpatient launch coincides with the effective date of July 1st for outpatient reimbursement of DefenCath® as directed by the Center for Medicare & Medicaid Services (CMS).

Late last year, CorMedix announced that the US Food and Drug Administration (FDA) had approved DefenCath® (taurolidine and heparin) catheter lock solution (CLS) to reduce the incidence of catheter-related bloodstream infections (CRBSIs) for the limited population of adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter (CVC). DefenCath® is the first and only FDA-approved antimicrobial CLS in the U.S. and was shown to reduce the risk of CRBSIs by up to 71% in a Phase 3 clinical study.

Vir Biotechnology, Inc., an immunology company focused on powering the immune system to transform lives by treating and preventing infectious diseases and other serious conditions, including viral-associated diseases, recently announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application and granted Fast Track designation for the combination of tobevibart and elebsiran for the treatment of chronic hepatitis delta infection. Tobevibart, an investigational monoclonal antibody, and elebsiran, an investigational small interfering ribonucleic acid, are currently being evaluated in the Company's Phase 2 SOLSTICE hepatitis delta clinical trial, with complete 24-week treatment data on track to be reported in the fourth quarter.

"The IND clearance and Fast Track designation from the FDA, along with the encouraging preliminary data from our Phase 2 hepatitis delta trial, underscore the potential of tobevibart and elebsiran to transform the treatment landscape for people living with this severe and life-threatening disease," said Marianne De Backer, M.Sc., Ph.D., MBA, Vir's Chief Executive Officer. "We are committed to working closely with health authorities to bring this potential groundbreaking treatment to patients as quickly as possible, addressing a critical unmet medical need."

Some of the biggest pharma companies including Abbott Laboratories, are grabbing market share in the blood infections testing market, estimated at over 875 Million in 2023.

From testing to treatments, the life threatening bloodstream infection market is seeing breakthroughs in technology to answer the call.

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