SCYNEXIS Presents Positive Interim Data of Ibrexafungerp for Refractory Candida Infections from Ongoing Phase 3 FURI Study During the Mycoses Study Group Education and Research Consortium (MSGERC) Biennial Meeting

Rhea-AI Summary

SCYNEXIS recently presented positive interim data from two Phase 3 studies: FURI and CARES, focusing on the antifungal ibrexafungerp. In the FURI study, 83% of patients with refractory Candida infections showed positive clinical outcomes, with 56% achieving complete or partial responses. The CARES study reported an 89% positive outcome in patients with Candida auris infections, with a 78% complete or partial response rate. These results highlight ibrexafungerp's potential against multi-drug resistant fungal infections, representing a significant advancement in treatment options.

Positive

• 83% of FURI patients with refractory Candida infections had positive clinical outcomes.
• 89% of CARES study patients with Candida auris infections showed positive outcomes.
• Ibrexafungerp demonstrates broad-spectrum antifungal activity against multidrug-resistant pathogens.

Negative

• 9% of FURI patients showed disease progression.
• One death in the CARES study was due to unrelated causes.

• Approximately 83% of FURI patients with refractory Candida infections had positive clinical outcomes, defined as complete/partial response (56%) or no disease progression (27%).

• Data from the ongoing Phase 3 CARES study will also be presented demonstrating positive outcomes of ibrexafungerp in 89% of patients with Candida auris, complete/partial response (78%) and no disease progression (11%).
  

JERSEY CITY, N.J., Sept. 08, 2022 (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 the presentation of positive interim data in patients with refractory candidiasis treated with oral ibrexafungerp from the ongoing Phase 3 FURI study, as well as data from the ongoing CARES study of patients with Candida auris (C. auris) infections. The new interim analyses are being presented during the Mycoses Study Group Education and Research Consortium (MSGERC) Biennial Meeting being held in Albuquerque, N.M., September 7-9, 2022.

“We are pleased to present to the scientific community these interim results from our ongoing FURI and CARES studies showing clinical benefits in patients with serious Candida fungal infections,” said Nkechi Azie, M.D., Vice President, Clinical Development and Medical Affairs at SCYNEXIS. “These encouraging results highlight the potential role of ibrexafungerp in treating a broad spectrum of challenging fungal diseases.”

The interim analysis included 64 patients from the FURI study with refractory Candida infections, including failure of or resistance to previous standard-of-care antifungal therapy. In the study, 56% of patients had a complete or partial response, 27% had stable response, 9% showed disease progression, and 8% were indeterminate (including one death due to underlying disease). Among these patients, 71% of refractory vulvovaginal candidiasis (VVC) cases (10/14) treated with an investigational dose regimen of ibrexafungerp showed clinical improvement as determined by vulvovaginal signs and symptoms score ≤1 at test of cure, 7% had stable response, 14% showed disease progression, and 7% were indeterminate.

Outcomes for the ongoing Phase 3 CARES study of ibrexafungerp in the treatment of patients with C. auris infections also are being presented at MSGERC. Of the 18 patients with invasive candidiasis/candidemia due to C. auris, 78% had a complete or partial response, 11% had stable response, one patient died of other causes, and one outcome was indeterminate.

The ongoing Phase 3 open-label, single-arm FURI study (NCT03059992) is evaluating oral ibrexafungerp for the treatment of patients with severe fungal infections who are either intolerant to standard antifungal therapy or experience refractory fungal infections despite treatment. The Phase 3 CARES study (NCT03363841) is evaluating oral ibrexafungerp in patients with systemic infections caused by C. auris, an organism that is often multi-drug resistant and associated with high mortality.

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. SCYNEXIS filed a supplemental New Drug Application (sNDA) to expand BREXAFEMME’s labelling to include the prevention of recurrent vulvovaginal candidiasis, and the FDA assigned a target PDUFA action date of November 30, 2022, for this additional indication. 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: 

Investors
Irina Koffler
LifeSci Advisors
ikoffler@lifesciadvisors.com

Media
Debbie Etchison
SCYNEXIS
Debbie.etchison@scynexis.com

FAQ

What were the results of the FURI study for SCYX?

In the FURI study, 83% of patients with refractory Candida infections had positive clinical outcomes, with 56% achieving complete or partial responses.

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

The CARES study demonstrated that 89% of patients with Candida auris infections had positive outcomes, which indicates the effectiveness of ibrexafungerp.

What is ibrexafungerp?

Ibrexafungerp is an antifungal agent from SCYNEXIS, targeting difficult-to-treat fungal infections, including those caused by Candida species.

What is the market potential for ibrexafungerp?

Given the increasing prevalence of drug-resistant fungal infections, ibrexafungerp has significant market potential as a treatment option.