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 outcomes from the CANDLE 304s nested sub-study investigating oral ibrexafungerp in patients with recurrent vulvovaginal candidiasis (RVVC) who failed fluconazole treatment.
The results were presented during the International Society for the Study of Vulvovaginal Diseases (ISSVD) XXVI World Congress and International Vulvovaginal Disease Update 2022 held in Dublin, Ireland, July 15-20, 2022.
“We are thrilled to present these data demonstrating positive outcomes in RVVC patients who failed fluconazole therapy for an acute VVC episode,” said Nkechi Azie, M.D., Vice President, Clinical Development and Medical Affairs at SCYNEXIS. “The response to ibrexafungerp in this clinically challenging population is extremely encouraging and further demonstrates the potential efficacy of ibrexafungerp to treat recurrent yeast infections in patients with limited treatment options. We hope to expand upon these data with the recently announced Phase 3b VANQUISH study.”
The CANDLE open-label sub-study enrolled 24 patients who failed to respond to an initial three-doses of fluconazole given over seven days. Fluconazole failure was defined as persistent vaginal signs and symptoms (VSS) score equal to or greater than three after therapy. Participants received a one-day treatment of ibrexafungerp (300 mg BID). In this population, 71% of patients (17 of 24) achieved a significant reduction or elimination of signs and symptoms after treatment with ibrexafungerp.
This positive trend was also confirmed in the subset of subjects who in addition to having a clinical failure also had persistent positive cultures after fluconazole treatment (microbiological failure). Favorable clinical response after a single day of ibrexafungerp was reported in eight of 10 subjects (80%) in this sub-group.
SCYNEXIS plans to present CANDLE main results next month during the Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) Annual Meeting being held in Boston, August 4-6, 2022.
In addition, SCYNEXIS recently announced the first patient enrolled in its Phase 3b, open-label, multicenter VANQUISH study to evaluate the efficacy, safety and tolerability of oral ibrexafungerp as a treatment for complicated vulvovaginal candidiasis (VVC) in patients who have failed treatment with fluconazole, based on mycological and clinical outcomes. Complicated patients include patients with recurrent VVC, those with VVC caused by non-albicans Candida species and those with diabetes, immunocompromising conditions (e.g., HIV), or immunosuppressive therapy (e.g., corticosteroids).
In June, SCYNEXIS submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for an additional indication for BREXAFEMME® (ibrexafungerp tablets) for the prevention of RVVC. The submission was based on positive results from the CANDLE study, which showed that ibrexafungerp successfully achieved statistically significant superiority over placebo for the primary and key secondary study endpoints.
About the CANDLE Study
CANDLE was a Phase 3, multi-center, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of oral ibrexafungerp compared to placebo in 260 female patients with RVVC, defined as three or more episodes of VVC in the previous 12 months. The primary endpoint was clinical efficacy as measured by the percentage of subjects with documented Clinical Success (defined as subjects having no culture-proven, presumed or suspected recurrences of VVC through the test-of-cure (TOC) evaluation at Week 24).
All patients in the CANDLE study initially received a three-day regimen of oral fluconazole to treat their acute episode present at screening. Patients who responded to oral fluconazole for their acute episode were enrolled in the prevention of recurrence phase of the study and randomized to oral ibrexafungerp (300 mg BID for one day) or placebo, given once per month for six months (a total of six treatment days). Patients who failed to sufficiently respond to fluconazole treatment for their acute episode were included in an open-label sub-study, in which they were offered one day of oral ibrexafungerp treatment (300 mg BID) for the unresolved acute episode.
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 U.S. Food and Drug Administration (FDA) approved BREXAFEMME® (ibrexafungerp tablets) on June 1, 2021. The FDA also 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.
BREXAFEMME is a triterpenoid antifungal indicated for the treatment of adult and postmenarchal pediatric females with vulvovaginal candidiasis (VVC).
DOSAGE AND ADMINISTRATION
The recommended dosage of BREXAFEMME is 300 mg (two tablets of 150 mg) twice a day for one day, for a total treatment dosage of 600 mg. BREXAFEMME may be taken with or without food.
IMPORTANT SAFETY INFORMATION
BREXAFEMME is contraindicated during pregnancy and in patients with a history of hypersensitivity to ibrexafungerp
BREXAFEMME administration during pregnancy may cause fetal harm based on animal studies. Prior to initiating treatment, verify pregnancy status in females of reproductive 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 a day for one day. Administration of BREXAFEMME with strong CYP3A inducers should be avoided
Most common adverse reactions observed in clinical trials (incidence ≥2%) were diarrhea, nausea, abdominal pain, dizziness, and vomiting
To report SUSPECTED ADVERSE REACTIONS, contact SCYNEXIS, Inc. at 1-888-982-SCYX (1-888-982-7299) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.