Biotech startup Scynexis has an antifungal in late-stage clinical development.
The Centers for Disease Control (CDC) has been concerned about the spread of the fungus Candida auris, but only recently has the difficult to diagnose — and treat — this infection begun to receive worldwide attention.
That may be because it is largely drug-resistant and infections have been found in countries ranging from India, Pakistan and South Africa to Venezuela, Britain and the United States. Infections are most commonly seen in people with compromised immune systems; greater than one in three patients with C. auris infections of the blood, heart or brain die. The CDC has determined that C. auris is a “serious global health threat.” Through February 28, the CDC had already confirmed 587 cases in 2019 and identified another 30 probable infections.
What is also concerning about C. auris is that it can be transferred from one person to another on clothes, skin, walls and other objects. It can stick to most anything and is also very persistent.
A small biotech company based in the United States –– Scynexis –– is one company that may have a potential treatment for C. auris infections. According to CEO Marco Taglietti, Scynexis is the only company assessing an investigational treatment in C. auris, but he expects others will follow now that concerns have reached such a heightened level.
Currently, there are three classes of antifungals on the market, most of which were commercialized in the 1980s. As a result, many fungi are developing resistance. The new candidate from Scynexis –– ibrexafungerp –– falls into a new class of antifungals referred to as glucan synthase inhibitors. It has been shown to be effective against a wide range of fungal infections, including resistant strains.
The company is in the midst of a large late-stage open-label clinical study in C. auris, and recently presented data on two patients that were successfully treated with the oral drug. Scynexis is hoping to get ibrexafungerp approved in the United States via the limited population pathway for antibacterial and antifungal drugs (LPAD) and is working with the FDA to determine how much clinical data will be necessary for the agency to make a decision.
Ibrexafungerp is also being investigated in a phase III study for the treatment of vaginal yeast infections.
One challenge to developing antifungals, according to Taglietti, is that they do not receive the same funding support granted to antibacterials and antivirals –– a situation that perhaps may change given the nature of C. auris.