SCYNEXIS Announces Submission – GuruFocus.com
- The filing for the extension is supported by positive data from the pivotal phase 3 CANDLE study, in which ibrexafungerp successfully achieved statistically significant superiority over placebo for the primary and key secondary study endpoints.
- If approved, BREXAFEMME would be the first and only non-azole oral treatment to prevent recurrent vaginal yeast infections.
- In the phase 3 CANDLE study in RVVC, ibrexafungerp was generally safe and well tolerated, with results consistent with the existing BREXAFEMME labeling.
JERSEY CITY, NJ, June 8, 2022 (GLOBE NEWSWIRE) — SCYNEXIS, Inc. ( SCYX), a biotechnology company pioneering innovative medicines to help overcome and prevent difficult-to-treat and drug-resistant infections, today announced it has submitted a Supplemental Marketing Authorization Application (sNDA) to the U.S. Food and Drug Administration (FDA) for an additional indication for BREXAFEMME® (Ibrexafungerp tablets) for the prevention of recurrent vulvovaginal candidiasis (RVVC).
BREXAFEMME, approved by the U.S. FDA in June 2021 for the treatment of vulvovaginal candidiasis (VVC), is a novel class of antifungal drug and the first and only oral fungicide capable of curing vaginal yeast infection in adults and postmenarchal pediatric patients . If approved for the additional indication, BREXAFEMME would be the first and only non-azole oral treatment for the prevention of recurrent yeast infections, defined as three or more episodes of VVC in the previous 12 months.
“This is an exciting and very important step in our efforts to bring our innovative, potent antifungal to market as a new alternative for women with recurrent yeast infections,” said Marco Taglietti, MD, President and Chief Executive Officer of SCYNEXIS. “As the only non-azole oral therapy available for VVC, BREXAFEMME is already revolutionizing the treatment of yeast infections. Based on our pivotal CANDLE study for RVVC, we now see that Ibrexafungerp, which can kill the yeast that causes the infection, has shown that it can also prevent the disease from coming back and help patients who are not responding to multiple doses of fluconazole have addressed. We are excited about this advancement, which brings us one step closer to our vision to address this significant unmet need in women’s health.”
The sNDA submission is based on positive results from the global Phase 3 SCYNEXIS (CANDLE) study, which evaluated the safety and efficacy of monthly dosing of ibrexafungerp for the prevention of RVVC and showed that 65.4% of patients receiving ibrexafungerp achieved clinical success without recurrence, all culturally confirmed, suspected, or suspected by week 24 compared to 53.1% of placebo-treated patients (p=0.02). The benefit of ibrexafungerp over placebo persisted through the 3-month follow-up period and remained statistically significant (p=0.034). In the study, ibrexafungerp was generally safe and well tolerated. The most frequently reported adverse events, headache and gastrointestinal disorders (ie diarrhea, nausea), were mostly mild and generally consistent with the current BREXAFEMME labeling.
Ibrexafungerp has been designated by the FDA as a Qualified Infectious Disease Product (QIDP), allowing for a 6-month priority review. SCYNEXIS anticipates potential regulatory approval by the end of 2022.
About BREXAFEMME® (Ibrexafungerp tablets)
BREXAFEMME is a novel oral antifungal approved for the treatment of vulvovaginal candidiasis (VVC), also known as vaginal yeast infection. Its mechanism of action, the inhibition of glucan synthase, counteracts fungicides Candida Art, meaning it kills fungal cells. BREXAFEMME was approved by the U.S. Food and Drug Administration (FDA) on June 1, 2021. The approval was supported by positive results from two randomized, double-blind, placebo-controlled, multi-center, Phase 3 studies (VANISH-303 and VANISH-306) in which oral ibrexafungerp demonstrated efficacy and a favorable safety profile in women with VVC. BREXAFEMME is the first approved drug in a new class of antifungal drugs in over 20 years and is the first and only treatment for vaginal yeast infections that is both oral and non-azole.
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.
About the CANDLE study
CANDLE was a Phase 3, multi-center, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of oral ibrexafungerp versus placebo in 260 patients with RVVC, defined as three or more episodes of VVC in the past 12 months. The primary endpoint was clinical efficacy as measured by the percentage of subjects with documented clinical success (defined as subjects with no culturally proven, suspected, or suspected recurrences of VVC by the test-of-cure (TOC) evaluation at week 24). All patients in the CANDLE study initially received a 3-day course of oral fluconazole to manage their acute episode at screening. Patients who responded to oral fluconazole for their acute episode entered the recurrence prevention phase of the study and were randomized to receive either oral ibrexafungerp (300 mg twice daily for one day) or placebo, once monthly for six months (six treatments total). days). Patients who did not respond adequately to treatment with fluconazole for their acute episode were enrolled in an open-label substudy where they were offered 1-day oral treatment with ibrexafungerp (300 mg twice daily) for the unresolved acute episode.
SCYNEXIS, Inc. (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 compound, Ibrexafungerp, as a broad-spectrum systemic antifungal for multiple fungal indications in both the community and hospital setting. SCYNEXIS launched 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. For more information visit www.scynexis.com.
Statements contained in this press release regarding anticipated 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 relating to: ibrexafungerp’s ongoing filing of an sNDA for RVVC, its potential use by physicians and patients in multiple healthcare settings. Because such statements involve risks and uncertainties, actual results could differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: risks inherent in SCYNEXIS’ ability to successfully develop ibrexafungerp and receive FDA approval for additional indications, including the IV formulation of ibrexafungerp; unexpected delays may occur in the time FDA accepts an NDA filing; the expected costs of the course and when it can begin or end; SCYNEXIS’ need for additional capital resources; and SCYNEXIS’ reliance on third parties to conduct SCYNEXIS’ clinical trials and commercialize its products. These and other risks are more fully described in SCYNEXIS’ filings with the Securities and Exchange Commission, including but not limited to its most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, each including under the heading “Risk Factors” and other documents subsequently filed with or served on the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date they are made. SCYNEXIS undertakes no obligation to update any such statements to reflect events or circumstances after the date on which they are made.