(National Library of Medicine, NIH)
11 Apr. 2019. Results from a clinical trial show an experimental anti-fungal drug effective in 2 cases of Candida auris infections, a fungus resistant to most other drugs. Findings from the study testing the drug Ibrexafungerp are scheduled for presentation on Saturday by staff from the biotechnology company Scynexis Inc., developer of the treatment, at this year’s European Congress of Clinical Microbiology and Infectious Diseases, or ECCMID, in Amsterdam, the Netherlands.
Candida auris is a fungal infection receiving much recent media attention because it’s resistant to most known treatments for other Candida infections. Centers for Disease Control and Prevention calls Candida auris “an emerging fungus that presents a serious global health threat,” not only for its resistance to most anti-fungal drugs, but also because it occurs in health care settings and is difficult to identify with common lab methods, thus often misdiagnosed. As of the end of March, CDC reports 617 cases of Candida auris in the U.S., with more than 100 cases each in the states of New York, New Jersey, and Illinois.
Scynexis, in Jersey City, New Jersey develops drugs for infectious diseases, particularly those difficult to treat with most other therapies. Ibrexafungerp is the company’s lead product, in a class of drugs called triterpenoids, derived from natural products with protective properties against pathogens. The drug works by preventing fungus cells from producing sugar molecules, which weakens the cell walls and speeds their destruction. Some triterpenoids are also being tested as anti-cancer drugs. Scynexis is creating different formulations of Ibrexafungerp as an oral drug as well as intravenous infusions.
The company is testing Ibrexafungerp in a late-stage clinical trial among 30 patients in India and the U.S. with infections caused by Candida auris fungi. Participants with Candida auris infections are given Ibrexafungerp as an oral drug twice a day for the first 2 days, then once a day for up to 90 days, then tracked for another 6 weeks. There’s no control or comparison group. The study team is looking primarily at the drug’s success in clearing the infection, but also watching for adverse effects, recurrence of infections, and overall survival.
At the ECCMID meeting, a Scynexis team will report on the first 2 participants in the trial. One patient, a man with a history of several serious illnesses, including diabetes, stroke, and a brain abscess, who developed pneumonia and septic shock. During his hospitalization, he was found with a Candida auris infection, and after other drugs failed to clear the infection, began taking Ibrexafungerp. The results show Candida auris no longer appeared in the man’s blood after 48 hours, and continued receiving the drug for 17 days, with no further recurrence of the infection at the end of treatment, nor after the 6-week follow-up period.
The second patient, a woman with a history of diabetes and chronic kidney disease, was hospitalized with a respiratory infection and later developed septic shock. After treatment with antibiotics for the earlier infections, she was also found with Candida auris and began taking Ibrexafungerp. The woman responded to the drug, and like the man, also cleared her Candida auris infection, which continued for 22 days of treatment, and during the entire follow-up period. The researchers say brexafungerp was well-tolerated by both participants.
The company is giving 5 other presentations at the ECCMID meeting, reporting on clinical trials and preclinical studies of Ibrexafungerp against other types of Candida fungal infections.
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Hat tip: Endpoints News
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