An Exclusive Look at Scynexis and Attacking Resistant C. Auris
There is a war going on in the health care industry and the enemy is winning.
That enemy is bacteria, fungi and other pathogens that have become resistant to treatment with conventional medicines. Last year, the U.S. Centers for Disease Control said there are approximately two million people in the U.S. who become infected with bacteria that are resistant to antibiotics. Of those, about 23,000 people die annually. While drug-resistant bacteria, such as carbapenem-resistant Enterobacteriaceae, Clostridium difficile or Staphylococcus infections, garner many headlines, resistant fungi may be a more sinister and shadowy threat.
A recent New York Times article highlighted growing concerns about Candida auris, a dangerous fungal infection that can be fatal. It is highly resistant to current antibiotics. The infectious fungus can not only be transmitted from patient to patient, but it can also be transmitted to objects, which can then threaten other patients. The Times article noted that the fungus has swept across various parts of the world, from Europe to parts of Asia and Africa. It has also been found in the United States. A man at Mount Sinai Hospital in New York died from the fungus. After the patient expired, hospital officials discovered that his room was covered in the fungus spores as it had spread from him. The Times noted that specialized cleaning equipment had to be brought in and many floor and ceiling tiles had to be removed before the room could be used again.
That threat is frightening, but there is hope. New Jersey-based SCYNEXIS is aiming its lead compound ibrexafungerp against multiple serious fungal infections, including Candida auris and vulvovaginal candidiasis. Ibrexafungerp is the first representative of a novel family of compounds referred to by the company as "fungerps" (antifungal triterpenoids). Recent data has shown the medication is effective against the fatal Candida auris fungi. Two patients in the company’s late-stage open-label CARES study demonstrated that oral treatment with Ibrexafungerp cleared Candida auris from infected patients. The results of these two studies will be presented later this week at the European Congress of Clinical Microbiology and Infectious Diseases conference in Amsterdam. The data showed that both of these difficult-to-treat candidemia cases responded positively to oral ibrexafungerp, with clearance of the Candida auris infection at the end of treatment. Ibrexafungerp was well-tolerated by both patients.
Scynexis Chief Executive Officer Marco Taglietti, an infectious disease specialist, told BioSpace that if Ibrexafungerp is approved for Candida auris or PVP, it will be the first new class of drug approved as an anti-fungal in more than 20 years. Speaking from Europe ahead of ECCMID, said that the most recent oral anti-fungal medication was approved in the 1980s. Because of its widespread use over the past three decades, Taglietti said the fungi have become more resistant. The new class of treatments that Scynexis has developed is “exquisitely active” against c. auris, Taglietti said.
“At this point, we believe that our drug can become a critical tool against c. auris. We have seen efficacy in in vivo, in vitro and clinical studies,” he said.
However, as promising as Ibrexafungerp appears to be in treating c. auris, Taglietti said the limited number of case studies they have data from may be a concern for regulatory authorities. He said the company will initiate meetings with various regulatory agencies about a potential path forward to approval.
The company though is moving forward with its development program. Next year, Scynexis is eying a potential New Drug Application for Ibrexafungerp as a treatment for vulvovaginal candidiasis (VVC). Commonly known as a "vaginal yeast infection," VVC is the second most common cause of vaginitis. The infection can be associated with substantial morbidity, including significant genital discomfort, reduced sexual pleasure, psychological distress and loss of productivity.
While there are numerous companies focused on developing new antibacterial treatments, Taglietti said anti-fungal-focused companies are not as plentiful. He also noted that there are far fewer federal grant monies available for anti-fungal treatments.
“If there are no adequate incentives, sooner or later, we will lose our battle with the fungi. I am very happy that our drug is working but this is never-ending warfare,” Taglietti said.