SCYNEXIS to Present Ibrexafungerp Data at the 33rd Annual European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) April 15-18 in Denmark

Rhea-AI Summary

SCYNEXIS, a biotechnology company, has announced its presentation of interim data on various infection types from the ongoing Phase 3 FURI and CARES studies, along with the innovative MARIO trial design. This will occur at the 33rd Annual European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) from April 15-18, 2023, in Copenhagen, Denmark. Key presentations include:

• Oral Ibrexafungerp outcomes in urinary tract infections.
• Evaluation of Ibrexafungerp's efficacy alone and with other antifungals.
• A novel protocol for Ibrexafungerp as step-down therapy.

Ibrexafungerp, a groundbreaking antifungal agent, shows promise against drug-resistant infections. It has received FDA designations for invasive candidiasis and aspergillosis, highlighting its potential in treating difficult infections.

JERSEY CITY, N.J., April 13, 2023 (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 interim data across a diverse array of infection types from its ongoing Phase 3 FURI and CARES studies, as well as the innovative study design of its ongoing Phase 3 MARIO trial of oral ibrexafungerp treatment after an intravenous (IV) echinocandin, at the 33rd Annual European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) being held in Copenhagen, Denmark, April 15-18, 2023.

Oral e-Poster Presentation:

Title: Outcomes of Oral Ibrexafungerp in Subjects with Urinary Tract Infections from Two Phase 3 Open-Label Studies: Difficult-To-Treat Invasive Fungal Infections (FURI) and Infections with Candida auris (CARES)
Session: Oral e-Poster Flash Session (EF121): Arena 3: Fungal treatments around the world
Date: April 16
Session Time: 1:30 p.m. – 2:30 p.m. CET / 7:30 a.m. – 8:30 a.m. EDT
Presentation Time: 1:48 p.m. CET / 7:48 a.m. EDT
Presenter: Nkechi Azie, M.D., FIDSA (New Jersey, United States)

Poster Presentations:

Title: Evaluation of the Effect of Ibrexafungerp Alone and in Combination with Amphotericin B or Posaconazole against Mucor Strains on Time Kill Kinetics and Scanning Electron Microscopy
Poster Session 6C: Antifungal susceptibility testing & resistance (incl. surveillance)
Poster: P2020
Date: April 16
Time: 12:00 p.m. – 1:30 p.m. CET / 6:00 a.m. – 7:30 a.m. EDT
Presenter: Mahmoud Ghannoum, Ph.D. (Ohio, United States)

Title: A Novel Protocol Design to Study the Efficacy and Safety of Oral Ibrexafungerp as Step-Down Therapy Following Intravenous (IV) Echinocandin for the Treatment of Invasive Candidiasis (MARIO): Developing a Paradigm Shift to IV and Oral Anti-Cell Wall Therapy
Poster Session 6D: Antifungal drugs & treatment (incl. clinical trials)
Poster: P2055
Date: April 16
Time: 12:00 p.m. – 1:30 p.m. CET / 6:00 a.m. – 7:30 a.m. EDT
Presenter: Thomas Walsh, M.D., Ph.D. (hon) (Virginia, United States)

Title: Oral Ibrexafungerp FURI Study: Outcomes in Subjects with Intraabdominal Candidiasis
Poster Session 6D: Antifungal drugs & treatment (incl. clinical trials)
Poster: P2068
Date: April 16
Time: 12:00 p.m. – 1:30 p.m. CET / 6:00 a.m. – 7:30 a.m. EDT
Presenter: Philipp Koehler, M.D. (Cologne, Germany)

Title: Evaluating the In Vitro Efficacy of Ibrexafungerp (SCY-078) Against Isolates from Clinical Trial Involving Patients with Fungal Diseases that are Refractory to or Intolerant of Standard Antifungal Treatment (FURI)
Poster Session 6D: Antifungal drugs & treatment (incl. clinical trials)
Poster: P2047 
Date: April 16 
Time: 12:00 p.m. – 1:30 p.m. CET / 6:00 a.m. – 7:30 a.m. EDT 
Presenter: Mahmoud Ghannoum, Ph.D. (Ohio, United States)

Title: Scopulariopsis paisii Osteitis and Soft Tissue Infection Treated with Ibrexafungerp and Posaconazole 
Poster Session 13C: Fungal infections 
Poster: P3402 
Date: April 18 
Time: 12:00 p.m. – 1:30 p.m. CET / 6:00 a.m. – 7:30 a.m. EDT 
Presenter: Raphael Scheu (Düsseldorf, Germany)

For more information, see the ECCMID 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 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 is developing the company’s lead asset, ibrexafungerp, as a broad-spectrum, systemic antifungal for multiple fungal indications in both the community and hospital settings. The U.S. Food and Drug Administration (FDA) approved BREXAFEMME^® (ibrexafungerp tablets) in June 2021, for its first indication in vulvovaginal candidiasis (VVC), followed by a second indication in November 2022, for reduction in the incidence of recurrent VVC. Late-stage clinical investigation of ibrexafungerp for the treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing. Additional assets in the novel “fungerp” class of antifungals are currently in pre-clinical and discovery phase, including the compound SCY-247. For more information, visit www.scynexis.com.

CONTACT: 
Investor Relations
Irina Koffler
LifeSci Advisors
Tel: (646) 970-4681
ikoffler@lifesciadvisors.com

Media Relations
Debbie Etchison
SCYNEXIS
debbie.etchison@scynexis.com

FAQ

What is SCYNEXIS presenting at ECCMID 2023?

SCYNEXIS is presenting interim data from its Phase 3 FURI and CARES studies, and the MARIO trial design at the 33rd Annual ECCMID in Copenhagen from April 15-18, 2023.

When is SCYNEXIS's presentation on Ibrexafungerp?

The presentation on Ibrexafungerp will take place on April 16, 2023, as part of an oral e-poster flash session at ECCMID.

What are the key focuses of SCYNEXIS's ECCMID presentations?

The key focuses include outcomes of Ibrexafungerp in urinary tract infections, its combination efficacy with other antifungals, and its role as step-down therapy.

What is Ibrexafungerp used for?

Ibrexafungerp is used to treat multiple fungal infections, including those caused by Candida and Aspergillus species, particularly in drug-resistant cases.

What designations has Ibrexafungerp received from the FDA?

Ibrexafungerp has received QIDP, Fast Track designations, and Orphan Drug Designation for indications such as invasive candidiasis and invasive aspergillosis.