SCYNEXIS Announces Publication of Review Article Highlighting Ibrexafungerp as a Potential Novel Treatment for Invasive Mold Infections in the Journal of Fungi

Rhea-AI Summary

SCYNEXIS, Inc. has published a review highlighting the antifungal ibrexafungerp's potential against deadly fungal infections listed by the WHO. This novel treatment shows promise for immunocompromised patients facing invasive mold infections. Ibrexafungerp is noted for its effectiveness against drug-resistant species and its convenient oral dosing. Ongoing clinical trials aim to further validate its efficacy in treating mold infections. The widespread resistance to current antifungal treatments underscores the urgent need for novel therapies like ibrexafungerp.

Positive

• Ibrexafungerp demonstrates activity against fungal pathogens listed as priorities by the WHO.
• The drug shows effectiveness against drug-resistant fungal infections with a convenient once-daily oral dosing.
• Ongoing clinical trials (FURI and SCYNERGIA) are exploring its use in combination therapies and as a prophylactic agent.

Negative

• None.

Ibrexafungerp demonstrates activity against deadly fungal pathogens included in the World Health Organization’s (WHO) first fungal pathogens priority list

JERSEY CITY, N.J., Nov. 07, 2022 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and 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 Journal of Fungi.

“This review in the Journal of Fungi showcases ibrexafungerp as a potential treatment for invasive mold infections, which are a growing threat to public health, particularly in immunocompromised patients,” said David Angulo, M.D., Chief Medical Officer of SCYNEXIS and lead author of the publication. “The importance of this topic is further underscored by the recently published WHO fungal priority pathogens list to guide research, development and public health action, validating the need for new antifungal agents such as ibrexafungerp, which has shown a spectrum of activity against most of the fungal pathogens in this priority list.”

In the article, authors describe the need for novel treatment strategies to improve outcomes of difficult-to-treat invasive mold infections, as currently available treatments are limited, resistance against current antifungals is common and mortality remains high. Ibrexafungerp’s mechanism of action and mode of administration offer advantages compared to other antifungals, including activity against drug-resistant species and convenient once-daily oral dosing.

Preclinical studies featured in the article illustrate ibrexafungerp’s activity against a broad variety of fungal pathogens, including prevalent Aspergillus species, Mucorales as well as other molds often involved in systemic diseases. The authors emphasize that preclinical studies justify further clinical development of ibrexafungerp not only as a potential monotherapy for mold infections, but also as combination therapy or as a potential prophylaxis agent in patients with high risk of severe disease.

Two ongoing clinical trials will provide further insight into the potential of ibrexafungerp for the treatment of invasive mold infections. The FURI open-label study of ibrexafungerp for fungal diseases that are refractory to, or where patients are intolerant of standard antifungal therapies includes some patients with mold infections. The SCYNERGIA Phase 2 study is evaluating ibrexafungerp co-administered with voriconazole in patients with invasive pulmonary aspergillosis. Both studies are anticipated to complete enrollment by the end of 2022.

The full review article, titled “Ibrexafungerp, a Novel Triterpenoid Antifungal in Development for the Treatment of Mold Infections,” can be found here.

The WHO report on deadly pathogens, released in October 2022, can be found here.

About Ibrexafungerp

Ibrexafungerp [pronounced eye-BREX-ah-FUN-jerp] is an antifungal agent and the first representative of a novel class of structurally-distinct glucan synthase inhibitors, triterpenoids. This agent combines the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and intravenous (IV) formulations. Ibrexafungerp is in late-stage investigation and development for multiple indications, including life-threatening fungal infections caused primarily by Candida (including C. auris) and Aspergillus species in hospitalized patients. It has demonstrated broad-spectrum antifungal activity, in vitro and in vivo, against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains. The FDA granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for the 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 Product designation for the indication of IC. Ibrexafungerp is formerly known as SCY-078.

About SCYNEXIS

SCYNEXIS, Inc. (NASDAQ: SCYX) is a biotechnology company pioneering innovative medicines to help millions of patients worldwide 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 both the community and hospital settings. SCYNEXIS has initiated the launch of its first commercial product in the U.S., BREXAFEMME^® (ibrexafungerp tablets). The U.S. Food and Drug Administration (FDA) approved BREXAFEMME on June 1, 2021. The FDA has accepted the Company’s sNDA submission for prevention of recurrent vulvovaginal candidiasis (VVC) and assigned a PDUFA decision date of November 30, 2022. In addition, late-stage clinical investigation of oral ibrexafungerp for the treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing. For more information, visit www.scynexis.com.

CONTACT: 

Investor Relations
Irina Koffler
LifeSci Advisors
ikoffler@lifesciadvisors.com

Media Relations
Debbie Etchison
Debbie.etchison@scynexis.com

FAQ

What is ibrexafungerp and its significance for SCYNEXIS (SCYX)?

Ibrexafungerp is a novel antifungal agent developed by SCYNEXIS, targeting invasive fungal infections, especially in immunocompromised patients, and showing effectiveness against drug-resistant strains.

What does the WHO fungal pathogens priority list include?

The WHO fungal pathogens priority list includes fungal pathogens that pose the greatest threat to global health, underscoring the urgent need for new antifungal agents like ibrexafungerp.

What clinical trials is SCYNEXIS conducting for ibrexafungerp?

SCYNEXIS is conducting two clinical trials, FURI and SCYNERGIA, to evaluate ibrexafungerp's efficacy in treating invasive fungal infections.

How does ibrexafungerp compare to current antifungal treatments?

Ibrexafungerp offers potential advantages such as activity against drug-resistant species and a more convenient dosing regimen compared to existing antifungal treatments.

What is the expected outcome of SCYNEXIS's clinical trials for ibrexafungerp?

The clinical trials are expected to provide critical insights into ibrexafungerp's effectiveness and support its potential approval for treating invasive mold infections.