Developing a New Class of Antifungals

In a mature market of agents, the investigational therapy, ibrexafungerp, from Scynexis is looking at a few antifungal indications with a potential FDA approval in 2021.

The market for antifungals is a mature one and has not seen much in the way of development of new agents and therapies for several years.

One company looking to change that is Jersey City, New Jersey-based Scynexis with its investigational therapy, ibrexafungerp. This agent is a broad-spectrum, IV and oral antifungal agent representing a novel therapeutic class. It is in late-stage development for multiple indications, ranging from vaginal yeast infections to life-threatening fungal infections in hospitalized patients.

Scynexis announced last week that the US Food and Drug Administration (FDA) had accepted the company’s filing for a new drug application (NDA) for its oral formulation of ibrexafungerp for treatment of vaginal yeast infection.

“As we prepare for our first commercial launch of oral ibrexafungerp in the community setting in 2021, we are also excited about advancing ibrexafungerp for patients with serious and life-threatening infections in the hospital setting,” Scynexis CEO Marco Taglietti, MD, said.

Scynexis has also been engaged in 2 studies looking at other indications. For example, the company’s FURI study is evaluating oral ibrexafungerp as a salvage treatment in patients with a variety of difficult-to-treat mucocutaneous and invasive fungal infections that are refractory to, intolerant of current standards of care, or require a non-azole oral step-down therapy for treatment of azole-resistant species.

In addition, their CARES study is focused on hospitalized patients with invasive candidiasis caused by the multidrug-resistant Candida auris organism, which is associated with high mortality. “The analysis of our CARES study will provide the first clinical trial data of an investigational treatment against Candida auris, a multidrug-resistant fungus deemed an urgent threat by the CDC.”

New interim analysis of the data for these phase 3 studies is expected in the first quarter of next year.

Taglietti points out the lack of new therapies in this class, and how the company is looking to fill the void.

“When approved, ibrexafungerp would represent the first new antifungal class in over 20 years and, with the advancement of our IV formulation, ibrexafungerp could become the first new class offering the flexibility of both IV and oral formulations in over 40 years,” Taglietti stated.

Lastly, the company was approved to do a phase 1 study in South Africa with an IV formulation of their therapy and they are looking at a first quarter of 2021 timeline to start.

Taglietti spoke with Contagion® recently about his company, the prospective indications for ibrexafungerp, and the ongoing studies.