SCYNEXIS Announces Three Oral Presentations of Ibrexafungerp Demonstrating Clinical and In Vitro Activity Against Candida Species at the 31st ECCMID

Rhea-AI Summary

SCYNEXIS, Inc. (NASDAQ: SCYX) announced promising presentations for ibrexafungerp at the 31st European Congress of Clinical Microbiology and Infectious Diseases (ECCMID). The data highlight ibrexafungerp's effectiveness against challenging fungal infections, including drug-resistant Candida auris. In vitro studies showed broad activity of ibrexafungerp against 967 clinical isolates in Denmark. From the FURI study, 70% of patients with refractory fungal diseases demonstrated clinical improvement, while 80% of patients in the CARES study achieved a complete response for Candida auris infections.

Positive

• 70% of patients in the FURI study showed clinical improvement.
• 80% of patients in the CARES study had a complete response to ibrexafungerp for Candida auris infections.
• Broad activity against 967 clinical Candida isolates, including resistant strains.

Negative

• None.

• FURI and CARES presentations show ibrexafungerp’s strong clinical response in difficult-to-treat and refractory fungal infections in the hospital setting including Candida auris
  
• In vitro data demonstrates ibrexafungerp’s broad activity against 967 clinical Candida isolates from patients in Denmark, including strains resistant to echinocandins

JERSEY CITY, N.J., July 12, 2021 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced three oral presentations demonstrating the potential clinical utility of ibrexafungerp at the 31st European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), now available online.

“Fungal infections worldwide are becoming increasingly drug-resistant and more deadly, leaving patients with limited treatment options. However, we believe that ibrexafungerp has the potential to be effective against many drug-resistant fungal pathogens, like Candida auris, which has capitalized on the crowded hospital conditions created by the COVID-19 pandemic,” said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. “These presentations continue to build on the positive responses we’ve seen in both the CARES and FURI studies and support ibrexafungerp’s potential to be the treatment option that patients need. We continue to actively enroll patients in both studies.”

Oral Presentation details:

Title	EUCAST Ibrexafungerp (SCY-078) MICs for contemporary Danish Yeast Isolates
Abstract #	2993
Presenter	Karin M Jørgensen, PhD
Session	News in the Antifungal World: New Drugs and Resistance Mechanism
Highlights	An in vitro susceptibility analysis of 967 unique yeast isolates from 794 patients found that ibrexafungerp displayed broad activity. Additional analysis demonstrated that ibrexafungerp was active in most strains harboring mutations in the fks gene, commonly associated with echinocandin resistance.
Title	Outcomes of Oral Ibrexafungerp in 33 Patients with Refractory Fungal Diseases, Interim Analysis of a Phase 3 Open-label Study (FURI)
Abstract #	00665
Presenter	M. Hoenigl, MD
Session	Novel Antifungals: What's the Future?
Highlights	An interim analysis by an independent data review committee of 33 patients from the Phase 3 FURI study evaluating ibrexafungerp for the treatment of patients with refractory fungal disease found that 23 patients (70%) achieved clinical improvement, defined as complete or partial response. 7 patients (21%) maintained stable disease and 0 patients (0%) progressed. 3 patients (9%) were considered as indeterminate. Overall, ibrexafungerp was well-tolerated, with the most common treatment-related adverse events being gastrointestinal in nature.
Title	Outcomes of Oral Ibrexafungerp in the Treatment of Ten Patients with Candida auris Infections, from the CARES Study
Abstract #	01937
Presenter	N. Azie, MD
Session	New Insights into C. auris
Highlights	An interim analysis by an independent data review committee of 10 patients from the global Phase 3 CARES study evaluating ibrexafungerp for the treatment of patients with invasive candidiasis or candidemia due to Candida auris found that 8 patients (80%) had a complete response. One patient (10%) was considered indeterminate, and one patient (10%) died of other causes.

The abstracts are currently available on ECCMID’s website 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 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 New Drug Application (NDA) for BREXAFEMME^® (ibrexafungerp tablets) was approved by the U.S. Food and Drug Administration (FDA) on June 1, 2021. FDA also granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for the IV and oral 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. 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. We are developing our 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. The New Drug Application (NDA) for BREXAFEMME^® (ibrexafungerp tablets) was approved by the U.S. Food and Drug Administration (FDA) on June 1, 2021. For more information, visit www.brexafemme.com. We are also continuing late-stage clinical development of ibrexafungerp for the prevention of recurrent VVC as well as the treatment of life-threatening invasive fungal infections in hospitalized patients. For more information, visit www.scynexis.com. 

Forward-Looking Statements

Statements contained in this press release regarding expected future events or results are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements regarding: the potential clinical utility of ibrexafungerp and ibrexafungerp’s potential to be the treatment option that patients need. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited, to: BREXAFEMME may not be accepted by physicians and patients at the rate SCYNEXIS expects; risks inherent in SCYNEXIS' ability to successfully develop and obtain FDA approval for ibrexafungerp for additional indications; unexpected delays may occur in the timing of acceptance by the FDA of an NDA submission; the expected costs of studies and when they might begin or be concluded; SCYNEXIS’ need for additional capital resources; and SCYNEXIS' reliance on third parties to conduct SCYNEXIS' clinical studies and commercialize its products. These and other risks are described more fully in SCYNEXIS' filings with the Securities and Exchange Commission, including without limitation, its most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, including in each case under the caption "Risk Factors," and in other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. SCYNEXIS undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

CONTACT:

Investor Relations
Irina Koffler
Managing Director
LifeSci Advisors, LLC
646-970-4681 (w)
ikoffler@lifesciadvisors.com

Media Relations
Gloria Gasaatura
LifeSci Communications
646-970-4688
ggasaatura@lifescicomms.com

FAQ

What were the results of the FURI study for SCYX's ibrexafungerp?

In the FURI study, 70% of patients achieved clinical improvement.

What is the significance of the CARES study results for SCYX?

The CARES study found that 80% of patients with Candida auris infections had a complete response to ibrexafungerp.

How does ibrexafungerp perform against resistant fungal infections?

Ibrexafungerp demonstrated broad activity against 967 clinical Candida isolates, including resistant strains.

When were the findings about ibrexafungerp presented?

The findings were presented at the 31st European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) on July 12, 2021.