Hope on the Hudson

News regarding Candida auris, the deadly fungus spreading through hospitals and nursing homes in the New Jersey-metro region, raised frightening questions locally in recent weeks about a potential epidemic. At the same time scientists across the Atlantic were celebrating a possible breakthrough anti-fungal treatment for the disease.

In Amsterdam at the 2019 European Congress of Clinical Microbiology & Infectious Diseases, attendees were focused less on the difficult-to-treat fungus that is currently killing one in three people who contract it, and more on the fact that the most likely potential cure may have already been discovered in New Jersey.

At the conference, all eyes and ears were on Jersey City-based Scynexis and its promising antifungal drug ibrexafungerp. This oral treatment could be a game-changer in the fight against difficult-to-treat, life-threatening infections like Candida auris.

To date, no other drugs have been effective against the disease, according to the statistics released at the end of March by the Centers for Disease Control & Prevention.

Candida auris is not new; it was discovered a decade ago. However, it is spreading quickly around the globe now for three key reasons.

First, it’s hard to identify because confirmed diagnosis requires specialized lab equipment and technology which is not widely available around the world. Misdiagnosis can lead to inappropriate treatment, which allows the fungus to grow.

Second, because Candida auris affects severely ill people, it spreads quickly in places housing these populations, namely hospitals and nursing homes where workers wage a constant fight to keep surfaces and equipment free from contamination.

And third, existing therapies on the market have become resistant to the bug and have been rendered useless in fighting the pathogen.

However, there is hope on the horizon. Scynexis announced early results of two open label ibrexafungerp clinical trials and reported that it has successfully treated and cured Candida auris in two severely immunosuppressed individuals.

These two people contracted the disease in India, where the fungus is so prevalent (3 to 5 percent of patient populations in some Indian hospitals, according to the CDC) that Scynexis had no difficulty enrolling patients for the studies, said company President and Chief Executive Officer Marco Taglietti.

Potential effectiveness seen

On a recent Scynexis conference call for investors, Dr. Deven Juneja, assistant professor in the Department of Critical Care at the Max Super Specialty Hospital in New Delhi, said “[i]brexafungerp treatment outcomes seen today are important results that could change the way we treat these life-threatening infections.”

Dr. Jose Vazquez, a professor of medicine and infectious diseases at Augusta University in Georgia, echoed those sentiments on the call. “These results suggest that for patients with severe recalcitrant, refractory multi-drug resistant infections, ibrexafungerp has the potential to offer hope,” he said.

Scynexis Chief Medical Officer Dr. David Angulo noted that, “[o]ur ability to enroll and successfully treat patients in the [two] studies shows that there is a clear unmet medical need for a novel and more potent antifungal therapy, particularly an oral agent, to treat patients with these devastating fungal infections.”

Scynexis is the only U.S. drug company with an antifungal in late-stage clinical development that has successfully treated the Candida auris pathogen.

Candida auris, characterized as a “serious global health threat” by the CDC, affects people with compromised immune systems, such as cancer or transplant patients. The fungus is described by scientists as extremely “sticky” because it can live on surfaces such as the skin as well as medical equipment and even clothing for weeks, and is resistant to current antifungal treatments available on the market today.

The deadly fungus is widespread in India, Pakistan and South Africa and has more recently been diagnosed in the U.K., Venezuela and now the U.S.

According to the most recent reports, there are 104 confirmed cases (and 22 probable cases) in New Jersey. In New York, there are 309 confirmed cases (four probable cases). Chicago has also reported an increase in cases of Candida auris in recent months.

It’s important to note, said Taglietti, that in addition to severely ill patients who are at the highest risk for contracting Candida auris, another threat looms — making the need for a new drug to combat the fungus even more vital.

The fungus can colonize in healthy people, as well, he said, which creates two critical concerns.

First, if a healthy person who has the Candida auris fungus dormant in their system gets severely ill, they are at serious risk for getting the deadly condition. Second, the fungus also can be transmitted if a healthy person who has been colonized with Candida auris comes into contact with an immunosuppressed individual.

“This fungus has the ability to spread in both of these ways, and this is what worries the CDC,” the infectious disease specialist said.

“At present, there are fewer than 10 antifungal treatments on the market today. None of them appear to be effective in fighting the Candida auris pathogen,” Taglietti said, noting his company is in a race against time to get to market with the promising cure.

New compounds needed

There has not been a new antifungal to come to market in more than 20 years and most of those have been around for 40 years. They simply are no longer working to treat pathogens like Candida auris.

Ibrexafungerp is the first drug in a new class of antifungals called glucan synthase inhibitors, which have been shown to be effective against a broad range of fungal infections, including resistant strains.

While it has been known to take many years to get a new drug approved by the U.S. Food and Drug Administration, ibrexafungerp has been granted “qualified infectious disease product” (QIDP) status. As such Scynexis can apply for a Fast Track designation for the treatment of invasive candidiasis (including candida auris), invasive aspergillosis, and vulvovaginal candidiasis.

Additionally, Taglietti is looking forward to an FDA meeting on July 12 in Washington. Following the passage of the limited population pathway for antibacterial and antifungal drugs — established by the 21st Century Cures Act — the FDA can now grant approval for some anti-infective products on the basis of limited clinical data.

Both of Scynexis’ clinical studies will continue until ibrexafungerp is available on the market. Taglietti said he feels it’s important to make the drug available as a public service for anyone who needs it before it is fully FDA approved and commercially available.

“It’s time for a new class of antifungal drugs now. It’s so important because these germs are very smart and we need a new product that will help us fight the growing threat.”