JERSEY CITY, NJ, Nov. 07, 2022 (GLOBE NEWSWIRE) — SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative drugs to beat and prevent hard-to-treat, drug-resistant fungal infections , today announced the publication of a review article highlighting the potential use of ibrexafungerp as a novel treatment option for invasive infections caused by opportunistic molds in the Mushroom Diary.
“This review in the Mushroom Diary introduces ibrexafungerp as a potential treatment for invasive mold infections, which pose a growing public health threat, particularly in immunocompromised patients,” said David Angulo, MD, SCYNEXIS Chief Medical Officer and lead author of the publication. “The importance of this topic is further underscored by the recent publication List of WHO priority fungal pathogens to guide research, development and public health actionvalidating the need for new antifungal agents such as ibrexafungerp, which has shown a spectrum of activity against most fungal pathogens on this priority list.
In the article, the authors outline the need for new treatment strategies to improve outcomes for difficult-to-treat invasive mold infections, as currently available treatments are limited, resistance to current antifungals is common, and mortality remains high. The mechanism of action and mode of administration of Ibrexafungerp offer advantages over other antifungals, including activity against drug-resistant species and convenient once-daily oral administration.
The preclinical studies presented in the article illustrate the activity of ibrexafungerp against a wide variety of fungal pathogens, including Aspergillus species, Mucorales as well as other molds often implicated in systemic diseases. The authors emphasize that the preclinical studies support the further clinical development of ibrexafungerp not only as a potential monotherapy for mold infections, but also as a combination therapy or as a potential prophylactic agent in patients at risk. high in serious illness.
Two ongoing clinical trials will provide further insight into the potential of ibrexafungerp for the treatment of invasive mold infections. The open-label FURI study of ibrexafungerp for fungal diseases refractory or intolerant to standard antifungal therapy includes some patients with mold infections. The phase 2 SCYNERGIA study is evaluating ibrexafungerp co-administered with voriconazole in patients with invasive pulmonary aspergillosis. Enrollment for both studies is expected to be complete by the end of 2022.
The full review article, titled “Ibrexafungerp, a new triterpenoid antifungal in development for the treatment of mold infections”, can be found here.
The WHO report on deadly pathogens, published in October 2022, can be viewed here.
Ibrexafungerp [pronounced eye-BREX-ah-FUN-jerp] is an antifungal agent and the first representative of a new class of structurally distinct glucan synthase inhibitors, the triterpenoids. This agent combines the well-established activity of glucan synthase inhibitors with the potential flexibility of having both oral and intravenous (IV) formulations. Ibrexafungerp is in late-stage investigation and development for multiple indications, including life-threatening fungal infections caused primarily by candidiasis (including C.auris) and Aspergillus species in hospitalized patients. It has demonstrated broad-spectrum antifungal activity, in vitro and live, against multidrug-resistant pathogens, including strains resistant to azoles and echinocandins. The FDA has granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for oral and IV formulations of ibrexafungerp for the indications of invasive candidiasis (IC), including candidemia, and invasive aspergillosis (IA) and has granted orphan drug designation for the IC and IA indications. The European Medicines Agency (EMA) has granted ibrexafungerp Orphan Medicinal Designation for the indication of IC. Ibrexafungerp is formerly known as SCY-078.
SCYNEXIS, Inc. (NASDAQ: SCYX) is a biotechnology company pioneering innovative medicines to help millions of patients around the world overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant. SCYNEXIS scientists are developing the company’s lead asset, ibrexafungerp (formerly known as SCY-078), as a broad-spectrum systemic antifungal for multiple fungal indications in community and hospital settings. SCYNEXIS has launched its first commercial product in the United States, BREXAFEMME® (ibrexafungerp tablets). The U.S. Food and Drug Administration (FDA) approved BREXAFEMME on June 1, 2021. The FDA accepted the company’s sNDA submission for the prevention of recurrent vulvovaginal candidiasis (VVC) and assigned a decision date PDUFA as of November 30, 2022. An intermediate-stage clinical study of oral ibrexafungerp for the treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing. For more information, visit www.scynexis.com.