Looking for "Firsts" in Health Care? Check Out Upcoming Catalysts for Citius Pharmaceuticals

By Sara Bowman, Senior Staff Writer, Online Media Group, Inc.

CRANFORD, NJ, Aug. 4, 2016 /PRNewswire/ - 2016 is proving to be a transformational year for Citius Pharmaceuticals (OTCQB: CTXR).  Recently, the Company completed the acquisition of Leonard-Meron Biosciences, adding seasoned leadership and a promising treatment for catheter-related bloodstream infections (CRBSIs) called Mino-Lok™ to their portfolio.  Mino-Lok™ joined Hydro-Lido, an experimental treatment for hemorrhoids in mid-stage development and Suprenza, a FDA-approved phentermine-based product for weight loss.

Recognizing a shift in the weight loss market, Citius made the decisions to shelve its efforts with Suprenza and focus on Mino-Lok and Hydro-Lido, two products that carry far greater potential for the company.  "We are committed to being a small, very focused pharma," said Citius chief executive Myron Holubiak in a phone conversation.  "We see the opportunity to grow true value by carving out new markets with innovation and not chasing crowded spaces," he added.

Holubiak, who previously served as President of the pharma giant Roche Laboratories, founded Leonard-Meron Biosciences along with serial pharmaceutical entrepreneur Leonard Mazur, who now serves as Chairman of the Citius board.  The two founders have invested millions of their own money to advance their drug candidates, including a $3 million purchase of restricted CTXR stock by Mazur in March.

Mino-Lok and Hydro-Lido could represent two important industry firsts and benefit from expedited FDA pathways to make it to market.  Mino-Lok is a patented antibiotic lock solution utilizing a novel mixture of minocycline, edetate (disodium EDTA) and ethyl alcohol to break down bacterial biofilm and eradicate bacteria while providing anti-clotting properties to maintain patency and salvage infected indwelling central venous catheters (CVCs) without having to remove them from patients.

The High Cost of CRBSIs

The key to Mino-Lok is the ability to safely and efficiently destroy bacteria in CVCs in situ (while still inserted in the patient).  About seven million CVCs are used annually for a variety of applications in critically ill patients to administer fluids, medications, blood products and for hemodialysis.  CVCs, which are inserted through the arm or chest and threaded to a large vein near the heart, can be left in place for a long period of time, unlike peripheral venous catheters that deliver fluids near the skin's surface.

CRBSIs are often caused by multi-drug resistant bacteria and fungi, and are some of the most frequent, costly and potentially lethal complications of CVCs.  Despite best practices to prevent infections, some 500,000 patients each year develop these bloodstream infections and face the risk of death and serious morbidities. 

The standard of care today is to treat the patient with systemic antibiotic therapy and remove and replace the CVC at a new venous site, as there are no FDA-approved drug treatments to salvage the catheter.  In addition to increased risk of complications, such as pneumothorax and arterial puncture related to reinserting the CVC, there is the economic impact of roughly $10,000 for the CVC removal and replacement process.  More broadly, a 2011 study published on PubMed concluded, "The cost of CRBSIs is between $33,00 and $44,000 in the general adult ICU, between $54,000 and $75,000 in the adult surgical ICU, and approximately $49,000 in the pediatric ICU."

Holubiak said that the cost of Mino-Lok runs around $1,400, a substantial savings from CVC replacement and associated risks and expenses.  It needs to be noted that Mino-Lok exclusively eliminates pathogens in the catheter and that systemic antibiotics are still required to treat the patient's bacteremia.

Pivotal Study Coming

Mino-Lok was originally developed by clinicians and technologists at the venerable M.D. Anderson Cancer Center.  Through an exclusive worldwide license (excluding South America) signed in May 2014, Citius assumed control of the technology.  Mino-Lok has recently been designated by the FDA as a Qualified Infectious Disease Product (QIDP), making it eligible for priority review, the FDA's Fast Track program, and a five-year extension of market exclusivity under the Hatch-Waxman Act.

In a 90-patient Phase 2b trial, Mino-Lok demonstrated a 100% efficacy rate in salvaging infected CVCs.  In addition, no significant adverse events were reported in the Mino-Lok arm compared to 18% serious adverse events in patients where the infected CVC was removed and replaced.  Research on Mino-Lok shows it is able to eradicated some of the most difficult-to-treat pathogens, including Gram-positive, Gram-negative and fungi that are resistant to many of today's antibiotics.

Citius is now preparing for a 700-patient, multi-center pivotal Phase 3 study.  If enrollment, anticipated to include 50-65 clinical sites, goes as scheduled and the data validates the mid-stage research, Citius believes it can have a New Drug Application approved in about 30 months.

Hydro-Lido

As discussed in a recent press release from Citius, 10 million Americans suffer from hemorrhoids, a gastrointestinal disorder characterized by pain, swelling, itching and bleeding of hemorrhoidal veins.   According to the National Institute of Health, about 75% of people will have hemorrhoids at some point in their life.  Over 25 million units of over the counter topical hemorrhoid-treatment products are sold annually in the U.S.; and the estimated prescription market in the U.S. is over $1.0 billion.

The Company's Hydro-Lido product is a proprietary topical formulation combining hydrocortisone and lidocaine.  Hydrocortisone, an anti-inflammatory topical steroid, and lidocaine, an anesthetic product, are commonly used today to treat hemorrhoids.  However, there is not a single product today, either alone or in combination, backed by safety and efficacy data collected through the clinical trial process to receive FDA approval for the treatment of hemorrhoids.

Data from a 210-patient Phase 2a study evaluating Hydro-Lido in patients with Grade I and Grade II hemorrhoids was released in February.  The study was not powered to show statistical significance, but designed as a dose finding study to evaluate the optimal concentration of hydrocortisone and lidocaine in Hydro-Lido.  As such, patients received either a placebo or one of six active drug treatments.  Based upon patient feedback and physician assessments using the Global Score of Disease Severity, Hydro-Lido performed favorably compared to comparators with respect to faster onset of relief of symptoms and reduction in disease severity.  In fact, Hydro-Lido seemed to achieve greater relief of pain, discomfort, and itching in only two days compared to either of its components alone.

Mr. Holubiak informed us that further study is needed since the Phase 2a trial was designed to identify an optimal concentration and the data are too small to jump to conclusions; but, Citius is now prepared to conduct a Phase 2b trial and get the most precise evaluation of the efficacy of combination of hydrocortisone and lidocaine. 

"Our goal with Hydro-Lido is to successfully complete a Phase 2b trial and have it Phase 3 ready in order to pursue licensing opportunities," said Holubiak.  "We're talking about an untapped market with an FDA-approved therapy.  With a growing aging population, the market is going to get even bigger.  I suspect that there will be strong interest in Hydro-Lido with compelling data from a larger trial."

The Company is preparing to initiate a 300-patient Phase 2b trial during 2017.  With therapy only taking 14 days, this trial should move forward expeditiously.

Hydrocortisone and lidocaine are already both approved by the FDA separately. Citius can leverage safety data from the active ingredients to expedite development of Hydro-Lido through the FDA 505(b)(2) pathway.  Not only does it shorten development time, but it also conserves cash resources and can open the possibility of other incentives, including extended market exclusivity.

Two Firsts, Two Clinical Catalysts

2016 is proving to be transformational for Citius and 2017 will represent a tipping point with the initiation of clinical trials for Mino-Lok and Hydro-Lido.  Innovative products and large market opportunities are exactly what Wall Street likes to hear about.  With that in mind, a third catalyst also is on the horizon with the move to the NASDAQ exchange, which Myron Holubiak says is a high priority and targeted to happen during the first half of 2017.

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