Meeting News

C. auris: ‘A ticking time bomb’ in need of new treatment options

Marco Taglietti, MD
Marco Taglietti

WASHINGTON — Candida auris is a “ticking time bomb” — an aggressive and naturally resistant pathogen with few options for treatment, an expert said here, highlighting the need for more funding and research to address the threat of fungal pathogens.

C. auris is completely different than anything else we’ve seen, and it has a few attributes that make it particularly frightening,” said Marco Taglietti, MD, president and CEO of Scynexis, which is developing an antifungal to fight infections caused by Aspergillus and Candida species.

First, C. auris is naturally resistant to many of the few antifungals that are currently available, Taglietti noted. Second, it is very aggressive, killing up to 60% of infected patients, he explained.

Taglietti was a speaker at the World Anti-Microbial Resistance Congress.

“The most scary [fact] of all, though, is that it is a yeast that can spread from patient to patient, infecting healthy people as well as the sick,” he told Infectious Disease News.

C. auris drew widespread attention in the United States after the CDC issued a clinical alert about the emerging fungus in June 2016. More recent headlines — including a front-page story in The New York Times — raised its profile even more, Taglietti noted.

Ten years after the fungus was first isolated in Japan, more than 50% of C. auris strains are resistant to one class of antifungals, 30% are resistant to two and some strains are resistant to all three classes, he said. In that regard, C. auris has been compared to a superbug.

“This is dangerous,” Taglietti said. “With antifungals, there aren’t hundreds of options for treatment; there are eight or nine, with little support for more.”

C. auris’ behavior also is worrisome. It can remain on surfaces, skin, clothing and walls for months, facilitating its spread.

“This creates a ticking time bomb,” Taglietti said.

C. auris has been identified in more than 35 countries, with more than 800 cases confirmed in the U.S., most of them in three states: Illinois, New Jersey and New York. Taglietti compared its spread to that of carbapenem-resistant Enterobacteriaceae (CRE).

“CRE is everywhere and is on the CDC’s list of urgent pathogens,” he said. “Is C. auris the next CRE? I see a similar pattern, so I say it’s better if we address this early.”

Addressing C. auris requires a multifaceted approach that pays close attention to diagnosis, containment, cleaning, and management of colonized and infected patients. According to Taglietti, a much-needed step is developing more antifungals.

Scynexis is developing a new antifungal called ibrexafungerp — formerly SCY-078 — that has demonstrated effectiveness in patients with C. auris. Unfortunately, Taglietti said, federal funding to develop drugs to treat fungal pathogens has been lacking.

“BARDA, which has responsibility to develop projects to protect the population from threats, has only invested in bacterial threats, not fungi. We need to change that — we need support for fungal infections, as they are becoming a major, major problem and we need alternative tools,” Taglietti said.

He said Scynexis has not been able to focus on developing ibrexafungerp for C. auris and instead has focused on vulvovaginal candidiasis.

According to results of the phase 3 VANISH-303 trial, oral ibrexafungerp showed statistically significant superiority over placebo for the treatment of vulvovaginal candidiasis and was deemed safe and well-tolerated. A second phase 3 study is expected to be completed in early 2020, supporting the submission of a New Drug Application with the FDA in 2019, Taglietti said. He said the company expects approval in 2021. – by Caitlyn Stulpin

Disclosures: Taglietti is an employee of Scynexis.

Marco Taglietti, MD
Marco Taglietti

WASHINGTON — Candida auris is a “ticking time bomb” — an aggressive and naturally resistant pathogen with few options for treatment, an expert said here, highlighting the need for more funding and research to address the threat of fungal pathogens.

C. auris is completely different than anything else we’ve seen, and it has a few attributes that make it particularly frightening,” said Marco Taglietti, MD, president and CEO of Scynexis, which is developing an antifungal to fight infections caused by Aspergillus and Candida species.

First, C. auris is naturally resistant to many of the few antifungals that are currently available, Taglietti noted. Second, it is very aggressive, killing up to 60% of infected patients, he explained.

Taglietti was a speaker at the World Anti-Microbial Resistance Congress.

“The most scary [fact] of all, though, is that it is a yeast that can spread from patient to patient, infecting healthy people as well as the sick,” he told Infectious Disease News.

C. auris drew widespread attention in the United States after the CDC issued a clinical alert about the emerging fungus in June 2016. More recent headlines — including a front-page story in The New York Times — raised its profile even more, Taglietti noted.

Ten years after the fungus was first isolated in Japan, more than 50% of C. auris strains are resistant to one class of antifungals, 30% are resistant to two and some strains are resistant to all three classes, he said. In that regard, C. auris has been compared to a superbug.

“This is dangerous,” Taglietti said. “With antifungals, there aren’t hundreds of options for treatment; there are eight or nine, with little support for more.”

C. auris’ behavior also is worrisome. It can remain on surfaces, skin, clothing and walls for months, facilitating its spread.

“This creates a ticking time bomb,” Taglietti said.

C. auris has been identified in more than 35 countries, with more than 800 cases confirmed in the U.S., most of them in three states: Illinois, New Jersey and New York. Taglietti compared its spread to that of carbapenem-resistant Enterobacteriaceae (CRE).

“CRE is everywhere and is on the CDC’s list of urgent pathogens,” he said. “Is C. auris the next CRE? I see a similar pattern, so I say it’s better if we address this early.”

Addressing C. auris requires a multifaceted approach that pays close attention to diagnosis, containment, cleaning, and management of colonized and infected patients. According to Taglietti, a much-needed step is developing more antifungals.

PAGE BREAK

Scynexis is developing a new antifungal called ibrexafungerp — formerly SCY-078 — that has demonstrated effectiveness in patients with C. auris. Unfortunately, Taglietti said, federal funding to develop drugs to treat fungal pathogens has been lacking.

“BARDA, which has responsibility to develop projects to protect the population from threats, has only invested in bacterial threats, not fungi. We need to change that — we need support for fungal infections, as they are becoming a major, major problem and we need alternative tools,” Taglietti said.

He said Scynexis has not been able to focus on developing ibrexafungerp for C. auris and instead has focused on vulvovaginal candidiasis.

According to results of the phase 3 VANISH-303 trial, oral ibrexafungerp showed statistically significant superiority over placebo for the treatment of vulvovaginal candidiasis and was deemed safe and well-tolerated. A second phase 3 study is expected to be completed in early 2020, supporting the submission of a New Drug Application with the FDA in 2019, Taglietti said. He said the company expects approval in 2021. – by Caitlyn Stulpin

Disclosures: Taglietti is an employee of Scynexis.

    See more from The World Anti-Microbial Resistance Congress