Citius Thrives in 2021 with Critical Care Solutions for ARDS Associated with COVID-19

The following post was written and/or published as a collaboration between Benzinga’s in-house sponsored content team and a financial partner of Benzinga.

Companies like Pfizer, Inc. (NYSE: PFE), Syndax Pharmaceuticals (NASDAQ: SNDX), Merck & Co. (NYSE: MRK), and Amgen, Inc. (NASDAQ: AMGN), among others, understand the importance of creating new, effective pharmaceutical critical care products for unmet needs.

For example, long-term patients with central venous catheters (CVCs) for dialysis or cancer treatments are still at risk for complications related to bloodstream infections that might be fatal. This creates a new set of needs in order to have successful outcomes for these patients. Finding ways to avoid these complications can be lifesavers.

Citius Pharmaceuticals, Inc. (NASDAQ: CTXR), a specialty pharmaceutical company dedicated to developing and commercializing novel critical care drug products, is addressing several of these unmet medical needs with cost-saving and cost-effective solutions with low-risk development pathways.

The company is currently advancing three proprietary product candidates: Mino-Lok®, CITI-002 (halobetasol-lidocaine formulation) and CITI-101 (Mino-Wrap).

The Mino-Lok solution, for example, allows catheters to be disinfected and salvaged to prevent the need to replace and restart a deadly and costly process.

Additionally, Citius recently signed an exclusive worldwide licensing agreement with Novellus, Inc., a privately-held biotechnology company creating new engineered cellular therapies for a novel stem-cell therapy that would initially target Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19.

Here’s what you need to know.

What is Acute Respiratory Distress Syndrome (ARDS)?

ARDS is a type of respiratory failure characterized by rapid onset of widespread inflammation and fluid accumulation in the lungs and is the most common cause of respiratory failure and mortality in COVID-19 patients.

ARDS affects approximately 250,000 people in the U.S. annually, exclusive of the current COVID-19 pandemic, and has a 30% to 50% mortality rate. It is reported that 31% of hospitalized COVID-19 patients develop ARDS.

ARDS impairs the lungs’ ability to exchange oxygen for carbon dioxide. Its symptoms include shortness of breath, rapid breathing and bluish skin coloration; for those who survive, a decreased quality of life is common.

The current clinical management is supportive care, through the use of a ventilator and fluid management, and in some instances, extracorporeal membrane oxygenation and glucocorticoids.

Currently, there is no FDA-approved drug therapy for ARDS.

Novellus – NoveCite i-MSCs

The Novellus cellular manufacturing process, using mRNA reprogramming, is unique and creates a mesenchymal stem cell (MSC) bank that is derived from induced pluripotent stem cells instead of harvesting cells from adult tissue.

I-MSCs can be produced rapidly, expanded quickly to much greater levels than adult-donor-derived MSCs, and may overcome the limitations of adult-derived MSCs, providing enhanced growth potential and overexpressing immunomodulatory proteins.

A recent study in mice showed that i-MSCs delayed disease progression and improved clinical score 43% improvement as compared to donor MSCs.

Citius recently submitted a pre-IND plan to the FDA under the new Coronavirus Treatment Acceleration Program (CTAP) for the treatment of ARDS in COVID-19 patients and desires to file an IND by Q4 2021.

Pursuing a New Standard of Care

Citius concentrates on adjunctive cancer therapies, critical care medicine and anti-infectives.

Its Mino-Lok solution is the first — and only — therapy under investigation that can be used to sterilize and salvage the infected CVC avoiding the complications, discomfort and costs of removal and replacement.

Currently, Mino-Lok is in late Phase 3 and received a favorable review for Futility Analysis by Data Monitoring Committee (12/2019); favorable review for safety and efficacy analysis in September 2020 and superior efficacy review in Q2 2021 (DMC).

Corporate Highlights

• Announced closing of $76.5 million registered direct offering priced at the market in February 2021

• Mino-Wrap™ in pre-clinical development with plans to submit IND to the FDA by the end of the year

• Mino-Lok® pivotal trial interim analysis and review by the Data Monitoring Committee (DMC) expected in Q2 2021

• Private placement for gross proceeds of $20 million and investors' exercise of warrants generating $4.5 million in gross proceeds completed in January 2021 and February 2021, respectively

• The preceding post was written and/or published as a collaboration between Benzinga’s in-house sponsored content team and a financial partner of Benzinga. Although the piece is not and should not be construed as editorial content, the sponsored content team works to ensure that any and all information contained within is true and accurate to the best of their knowledge and research. This content is for informational purposes only and not intended to be investing advice.

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