SCYNEXIS Presents New Interim – GuruFocus.com

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  • The data show that 71.4% of patients in the FURI study with refractory or recurrent vulvovaginal candidiasis (VVC) treated with ibrexafungerp had successful clinical outcomes.
  • Ibrexafungerp has shown positive results in difficult-to-treat VVC patients with severe fungal infections who are either intolerant of standard antifungal therapy or have had refractory infections despite treatment.
  • In the study, ibrexafungerp was generally safe and well tolerated, with results consistent with the existing product label.

JERSEY CITY, NJ, May 10, 2022 (GLOBE NEWSWIRE) — SCYNEXIS, Inc. (SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, announced a new positive presentation announced results in patients with refractory vulvovaginal candidiasis (VVC) treated with oral ibrexafungerp from the ongoing Phase 3 FURI study. The new interim analysis was presented during the American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting, held May 6-8, 2022 in San Diego.

“We are very encouraged by these data showing positive outcomes in VVC patients with severe refractory or recurrent infections,” said David Angulo, MD, SCYNEXIS Chief Medical Officer. “We are committed to advancing advances in women’s health and believe these results underscore the potential clinical utility of this novel agent in treating a broad spectrum of VVC cases.”

Of the 14 patients in the FURI study with refractory or recurrent cases of VVC treated with ibrexafungerp, 10 (71.4%) had successful clinical outcomes as assessed by an independent Data Review Committee. Patients with VVC received oral ibrexafungerp 750 mg (375 mg twice daily) every 72 hours for a total of three dosing days (Day 1, Day 4 and Day 7).

The ongoing open-label, single-arm, Phase 3 FURI study (NCT03059992) is evaluating orally administered Ibrexafungerp for the treatment of patients with severe fungal infections who are either intolerant to standard antifungal therapy or have refractory fungal infections despite treatment. In the study, ibrexafungerp was generally safe and well tolerated, with results consistent with existing BREXAFEMME® (Ibrexafungerp tablets) label.

Earlier this year, SCYNEXIS also announced positive results from its global Phase 3 CANDLE study evaluating the safety and efficacy of orally administered Ibrexafungerp for the prevention of recurrent vulvovaginal candidiasis (rVVC), also known as vaginal yeast infection. The Company plans to submit a supplemental New Drug Application (sNDA) based on the CANDLE data to the U.S. Food and Drug Administration (FDA) in the first half of 2022 and expects to receive approval for a obtain an extension of approval.

About Ibrexafungerp

Ibrexafungerp [pronounced eye-BREX-ah-FUN-jerp] is an antifungal and the first representative of a new class of structurally different glucan synthase inhibitors, the triterpenoids. This agent combines the well-established activity of glucan synthase inhibitors with the potential flexibility of oral and intravenous (IV) formulations. Ibrexafungerp is in late-stage development for multiple indications, including life-threatening fungal infections primarily caused by Candida (including C. auris) and Aspergillus species in hospitalized patients. It has shown broad antifungal activity, in vitro and in vivo, against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains. The US Food and Drug Administration (FDA) has approved BREXAFEMME® (Ibrexafungerp tablets) on June 1, 2021. The FDA approved oral and IV formulations of Ibrexafungerp for the indications invasive candidiasis (IC) (including candidemia) and invasive aspergillosis (IA) and has orphan drug designation for the Indications IC and IA granted. The European Medicines Agency (EMA) has granted Ibrexafungerp orphan medicinal product status for the indication IC. Ibrexafungerp is formerly known as SCY-078.

INDICATION

BREXAFEMME is a triterpenoid antifungal indicated for the treatment of adult and postmenarchal pediatric women with vulvovaginal candidiasis (VVC).

DOSAGE AND APPLICATION

The recommended dose of BREXAFEMME is 300 mg (two 150 mg tablets) twice a day for one day, for a total treatment dose of 600 mg. BREXAFEMME can be taken with or without food.

IMPORTANT SAFETY INSTRUCTIONS

  • BREXAFEMME is contraindicated during pregnancy and in patients with known hypersensitivity to ibrexafungerp
  • Based on animal studies, administration of BREXAFEMME during pregnancy may cause fetal harm. Before starting treatment, check pregnancy status in women of childbearing potential and advise them to use effective contraception during treatment
  • When administering BREXAFEMME with strong CYP3A inhibitors, the dose of BREXAFEMME should be reduced to 150 mg twice daily for one day. Administration of BREXAFEMME with strong CYP3A inducers should be avoided
  • The most common adverse reactions observed in clinical trials (incidence ≥ 2%) were diarrhoea, nausea, abdominal pain, dizziness and vomiting

To report SUSPECTED SIDE EFFECTS, contact SCYNEXIS, Inc. at 1-888-982-SCYX (1-888-982-7299) or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Visit www.brexafemme.com for more information. Please click here for prescribing information.

About SCYNEXIS

SCYNEXIS, Inc. (SCYX) is a biotechnology company pioneering the development of 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 compound, Ibrexafungerp (formerly known as SCY-078), as a broad-spectrum systemic antifungal for multiple fungal indications in both the community and hospital setting. SCYNEXIS has initiated the launch of its first commercial product in the US, BREXAFEMME® (Ibrexafungerp tablets). The U.S. Food and Drug Administration (FDA) approved BREXAFEMME on June 1, 2021. In addition, clinical testing and development of oral Ibrexafungerp for prevention of recurrent vulvovaginal candidiasis (VVC) and treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing. Visit www.scynexis.com for more information.

CONTACT:

Investor Relations
Irina Kofler
LifeSci Advisor
Tel: (646) 970-4681
[email protected]

Media Relations
Brett Whelan
LifeSci Communication
Tel: (339) 368-0466
[email protected]

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