Citius Thrives with Critical Care Solutions for ARDS tied to COVID-19

 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. CTXR 6.74%, 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

https://www.benzinga.com/general/biotech/21/04/20680831/citius-thrives-in-2021-with-critical-care-solutions-for-ards-associated-with-covid-19