SCYX SCYNEXIS Inc.

5.18
-0.27  -5%
Previous Close 5.45
Open 5.49
52 Week Low 4.25
52 Week High 10.25
Market Cap $120,268,769
Shares 23,217,909
Float 18,406,695
Enterprise Value $53,151,022
Volume 118,087
Av. Daily Volume 172,141
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Upcoming Catalysts

Drug Stage Catalyst Date
BREXAFEMME (ibrexafungerp) - SCYNERGIA
Invasive aspergillosis
Phase 2
Phase 2
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BREXAFEMME (ibrexafungerp) - CANDLE
Recurrent Vulvovaginal candidiasis (VVC)
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
BREXAFEMME (ibrexafungerp) - oral (FURI)
Invasive candidiasis
Phase 3
Phase 3
Phase 3 analysis March 2, 2021 - 46/64 patients recorded an overall response. Phase 3 interim data noted 46 (62.1%) patients showed CR or PR, 18 (24.3%) achieved SD, and 5 (6.8%) showed PD. One patient died due to an unrelated cause. In Oropharyngeal and Esophageal Candidiasis of 24 patients, 62.5% showed CR or PR, 29.2% achieved SD and 16.7% showed PD. In Bone and Joint Candidiasis of 8 patients 62.5% showed CR or PR, 12.5% achieved SD and 12.5% showed PD, noted September 29, 2021. Phase 3 interim data presented at TIMM October 9-10, 2021.
SCY-078 - oral - CARES
Candida Auris
Phase 3
Phase 3
Phase 3 interim analyses noted 8/10 complete responses - March 2, 2021. Phase 3 interim data presented at TIMM October 9, 2021.
BREXAFEMME (ibrexafungerp)
Vulvovaginal candidiasis (VVC)
Approved
Approved
FDA approval announced June 2, 2021.
Liposomal IV formulation of ibrexafungerp
Healthy volunteers
Phase 1
Phase 1
Phase 1 trial commenced March 2021.

Latest News

    • In the Phase 3 VANISH-303 study, ibrexafungerp demonstrated significantly higher rates of clinical cure and infection eradication versus placebo.
    • Post hoc analysis found ibrexafungerp demonstrated consistent efficacy in important patient sub-populations, characterized by race/ethnicity and body mass index.
    • In the Phase 2 DOVE study, ibrexafungerp demonstrated similar efficacy to the current standard of care at the Day 10 visit with sustained efficacy at the Day 25 follow-up visit.

    JERSEY CITY, N.J., Oct. 21, 2021 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant fungal infections, today announced the peer-reviewed publication…

    • In the Phase 3 VANISH-303 study, ibrexafungerp demonstrated significantly higher rates of clinical cure and infection eradication versus placebo.

    • Post hoc analysis found ibrexafungerp demonstrated consistent efficacy in important patient sub-populations, characterized by race/ethnicity and body mass index.
    • In the Phase 2 DOVE study, ibrexafungerp demonstrated similar efficacy to the current standard of care at the Day 10 visit with sustained efficacy at the Day 25 follow-up visit.

    JERSEY CITY, N.J., Oct. 21, 2021 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant fungal infections, today announced the peer-reviewed publication of results from its Phase 3 VANISH-303 and Phase 2 DOVE studies in the Infectious Diseases Society of America's Clinical Infectious Diseases.

    Findings from the pivotal Phase 3 VANISH-303 clinical trial led to the June approval by the U.S. Food and Drug Administration (FDA) of BREXAFEMME® (ibrexafungerp tablets) for the treatment of vulvovaginal candidiasis (VVC), the first new antifungal class of therapy in more than 20 years.

    "We hope the publication of these important findings from the groundbreaking research of our VANISH-303 study will provide clinicians valuable insight regarding the efficacy and safety of ibrexafungerp for the treatment of vaginal yeast infections," said David Angulo, M.D., Chief Medical Officer of SCYNEXIS. "With a distinct mechanism of action that effectively kills the fungi responsible for the infection, this treatment is an additional option for women across the country."

    Publication Details

    • Ibrexafungerp versus placebo for vulvovaginal candidiasis treatment: a Phase 3, randomized, controlled superiority trial (VANISH-303) – The randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of oral ibrexafungerp for the treatment of VVC, also known as vaginal yeast infection.



      • The study found that oral ibrexafungerp was statistically superior versus placebo in completely resolving signs and symptoms of VVC at Day 10 (50.5% [95/188] vs 28.6% [28/98], respectively; P=0.001) without the need for additional antifungal treatments, including topicals.

      • Results also showed superior mycological eradication (49.5% [93/188] vs 19.4% [19/98]; P<0.001), when compared with placebo.
      • Symptom resolution was sustained and further increased with ibrexafungerp compared with placebo (59.6% [112/188] vs 44.9% [44/98]; P=0.009) at follow-up.
      • Post hoc analysis showed similar rates of clinical cure and clinical improvement at test-of-cure for African American patients (54.8% [40/73] and 63.4% [47/73], respectively) and patients with a body mass index >35 (54.5% [24/44] and 68.2% [30/44], respectively) compared with overall rates.
      • Ibrexafungerp was well-tolerated. Adverse events were primarily gastrointestinal in nature and mild in severity.

    The full Phase 3 VANISH-303 trial publication can be found here.

    • Phase 2 randomized study of oral ibrexafungerp vs. fluconazole in vulvovaginal candidiasis – The results of the double-blind, randomized, dose-finding DOVE study, evaluated different regimens of ibrexafungerp and included fluconazole as comparator, the standard of care for the treatment of moderate to severe VVC. The study was designed to guide dose selection for the Phase 3 program and was not powered to demonstrate statistical differences among the groups. Patients with composite vulvovaginal signs and symptoms (VSS) scores greater than or equal to seven (≥7) were randomized equally to six treatments groups: five different dose regimens of oral ibrexafungerp or oral fluconazole 150 mg. The primary endpoint was the percentage of patients with a clinical cure, defined as complete resolution of VVC signs and symptoms at the test-of-cure visit on Day 10. Symptom resolution was also evaluated at Day 25.
      • The study identified the ibrexafungerp oral dose regimen of 300mg BID for one day as optimal for the Phase 3 program. The Day 10 clinical cure rate reported for this regimen was 51.9%, and 70.4% of patients reported no symptoms at Day 25. The active comparator (fluconazole) resulted in a Day 10 cure rate of 58.3% and 50.0% of patients with no symptoms at Day 25.*
      • The use of rescue antifungal medication during the study was reported in 3.7% of patients receiving the selected dose regimen of ibrexafungerp. For the same analysis, 29.2% of patients receiving fluconazole received rescue antifungal medications.*
      • Ibrexafungerp was well-tolerated, with the most common treatment-related adverse events being mild gastrointestinal events.

    *It should not be inferred from these results that a claim of superiority of ibrexafungerp over fluconazole for the treatment of vulvovaginal candidiasis is being made.

    The full Phase 2 DOVE publication can be found here.

    About Vulvovaginal Candidiasis (VVC)

    Vulvovaginal Candidiasis (VVC), commonly known as a vaginal yeast infection due to Candida, is the second most common cause of vaginitis. Although frequently caused by Candida albicans, infections caused by fluconazole-resistant and non-albicans Candida strains, such as Candida glabrata, have been reported to be on the rise.1 VVC can be associated with significant discomfort (pain, itching, burning), reduced sexual pleasure and activity, psychological distress (stress, depression, anxiety), embarrassment, reduced physical activity, and loss of productivity. An estimated 70-75% of women worldwide will have at least one episode of VVC in their lifetime, and 40-50% of those will experience multiple episodes.2

    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, glucan synthase inhibition, is fungicidal against Candida species, meaning it kills fungal cells.3 The New Drug Application (NDA) for BREXAFEMME was approved by the U.S. Food and Drug Administration (FDA) on June 1, 2021. The NDA was supported by positive results from two Phase 3, randomized, double-blind, placebo-controlled, multi-center studies (VANISH-303 and VANISH-306), in which oral ibrexafungerp demonstrated efficacy and a favorable tolerability profile in women with VVC. BREXAFEMME represents the first approved drug in a new antifungal class in over 20 years and is the first and only treatment for vaginal yeast infections which is both oral and non-azole.4

    INDICATION

    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.

    For more information, visit www.brexafemme.com. Click here for full Prescribing Information.

    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), which was approved by the U.S. Food and Drug Administration (FDA) on June 1, 2021. In addition, late-stage clinical investigation of ibrexafungerp for the prevention of recurrent vulvovaginal candidiasis (rVVC) and the treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing. For more information, visit www.scynexis.com

    CONTACT: 



    Investor Relations

    Irina Koffler

    LifeSci Advisors

    Tel: (646) 970-4681

    ikoffler@lifesciadvisors.com

    Media Relations

    Gloria Gasaatura

    LifeSci Communications

    Tel: (646) 970-4688

    ggasaatura@lifescicomms.com

    ____________________________

    1 Berkow EL, Lockhart SR. Fluconazole resistance in Candida species: a current perspective. Infect Drug Resist. 2017;10:237-245. Published 2017 Jul 31. doi:10.2147/IDR.S118892. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5546770/ Accessed September 7, 2021.

    2 Zeng X, Zhang Y, Zhang T, Xue Y, Xu H, An R. Risk Factors of Vulvovaginal Candidiasis among Women of Reproductive Age in Xi'an: A Cross-Sectional Study. Biomed Res Int. 2018;2018:9703754. Published 2018 Jun 7. doi:10.1155/2018/9703754. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6011108/ Accessed September 7, 2021.

    3 BREXAFEMME® U.S. prescribing information. June 2021.

    4 Nosanchuk JD. Current status and future of antifungal therapy for systemic mycoses. Recent Pat Antiinfect Drug Discov. 2006 Jan;1(1):75-84. doi: 10.2174/157489106775244109. PMID: 18221136. https://pubmed.ncbi.nlm.nih.gov/18221136/ Accessed September 7, 2021.



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  1. JERSEY CITY, N.J., Oct. 13, 2021 (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 presentations of a pooled data analysis from its successful VANISH clinical development program during two October medical meetings: the Nurse Practitioners in Women's Health (NPWH) 24th Annual Premier Women's Healthcare Conference and the 4th Congress of the International Society for Infectious Diseases in Obstetrics and Gynecology (ISIDOG).

    "Prior to the approval this year of BREXAFEMME® (ibrexafungerp tablets), the treatment landscape for vaginal yeast infections had not seen a new class of antifungals since the…

    JERSEY CITY, N.J., Oct. 13, 2021 (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 presentations of a pooled data analysis from its successful VANISH clinical development program during two October medical meetings: the Nurse Practitioners in Women's Health (NPWH) 24th Annual Premier Women's Healthcare Conference and the 4th Congress of the International Society for Infectious Diseases in Obstetrics and Gynecology (ISIDOG).

    "Prior to the approval this year of BREXAFEMME® (ibrexafungerp tablets), the treatment landscape for vaginal yeast infections had not seen a new class of antifungals since the 1990s despite the fact that three out of four women suffer from this condition at least once over the course of their lives," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "We are deeply committed to innovation in the field of women's health and are extremely pleased to be able to share this additional pooled data analysis from our groundbreaking VANISH clinical research."

    Data Presentation Details:

    24th Annual NPWH Premier Women's Healthcare Conference, October 13-16, 2021

    Product Theater:

    Title: BREXAFEMME® (ibrexafungerp tablets) – A Novel, Oral Treatment for Vulvovaginal Candidiasis

    Location: Virtual

    Date: Thursday, October 14, 2021

    Time: 2:00 p.m. – 3:00 p.m. EDT

    Poster Presentation:

    Title: Efficacy and Safety of Oral Ibrexafungerp in Subjects with Vulvovaginal Candidiasis: Pooled Data from Two Phase 3, Randomized, Blinded, Study vs. Placebo (VANISH-303 and VANISH-306)

    Poster: #326

    Learn more about the NPWH virtual conference here. Meeting attendees can view the conference sessions and posters on demand until January 12, 2022.

    4th Congress of the International Society for Infectious Diseases in Obstetrics and Gynecology (ISIDOG), October 14-17, 2021

    Presentation:

    Session 9, Free Oral Communications #3 (Candida & Other): F.13 Efficacy and Safety of Oral Ibrexafungerp in Subjects with Vulvovaginal Candidiasis: Pooled Data from Two Phase 3, Randomized, Blinded, Study vs. Placebo (VANISH-303 and VANISH-306)

    Date: Saturday, October 16, 2021

    Location: Budapest, Hungary, and online/virtual

    Time: 2:30 a.m. – 3:50 a.m. EDT / 8:30 a.m. – 9:50 a.m. (CEST)

    Presenter: Nkechi Azie, M.D., FIDSA, Vice President, Clinical Development and Medical Affairs, SCYNEXIS

    Learn more about the ISIDOG 2021 hybrid congress here.

    About Vulvovaginal Candidiasis (VVC)

    Vulvovaginal Candidiasis (VVC), commonly known as a vaginal yeast infection due to Candida, is the second most common cause of vaginitis. Although frequently caused by Candida albicans, infections caused by fluconazole-resistant and non-albicans Candida strains, such as Candida glabrata, have been reported to be on the rise.1 VVC can be associated with significant discomfort (pain, itching, burning), reduced sexual pleasure and activity, psychological distress (stress, depression, anxiety), embarrassment, reduced physical activity, and loss of productivity. An estimated 70-75% of women worldwide will have at least one episode of VVC in their lifetime, and 40-50% of those will experience multiple episodes.2

    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, glucan synthase inhibition, is fungicidal against Candida species, meaning it kills fungal cells.3 The New Drug Application (NDA) for BREXAFEMME was approved by the U.S. Food and Drug Administration (FDA) on June 1, 2021. The NDA was supported by positive results from two Phase 3, randomized, double-blind, placebo-controlled, multi-center studies (VANISH-303 and VANISH-306), in which oral ibrexafungerp demonstrated efficacy and a favorable tolerability profile in women with VVC. BREXAFEMME represents the first approved drug in a new antifungal class in over 20 years and is the first and only treatment for vaginal yeast infections which is both oral and non-azole.4

    INDICATION

    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.

    For more information, visit www.brexafemme.com. Click here for full Prescribing Information.

    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, which was approved by the U.S. Food and Drug Administration (FDA) on June 1, 2021. In addition, late-stage clinical investigation of ibrexafungerp for the prevention of recurrent vulvovaginal candidiasis (rVVC) and the treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing. For more information, visit www.SCYNEXIS.com.

    CONTACT: 



    Investor Relations

    Irina Koffler

    LifeSci Advisors

    Tel: (646) 970-4681

    ikoffler@lifesciadvisors.com

    Media Relations

    Gloria Gasaatura

    LifeSci Communications

    Tel: (646) 970-4688

    ggasaatura@lifescicomms.com


    1 Berkow EL, Lockhart SR. Fluconazole resistance in Candida species: a current perspective. Infect Drug Resist. 2017;10:237-245. Published 2017 Jul 31. doi:10.2147/IDR.S118892. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5546770/ Accessed September 7, 2021.

    2 Zeng X, Zhang Y, Zhang T, Xue Y, Xu H, An R. Risk Factors of Vulvovaginal Candidiasis among Women of Reproductive Age in Xi'an: A Cross-Sectional Study. Biomed Res Int. 2018;2018:9703754. Published 2018 Jun 7. doi:10.1155/2018/9703754. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6011108/ Accessed September 7, 2021.

    3 BREXAFEMME® U.S. prescribing information. June 2021.

    4 Nosanchuk JD. Current status and future of antifungal therapy for systemic mycoses. Recent Pat Antiinfect Drug Discov. 2006 Jan;1(1):75-84. doi: 10.2174/157489106775244109. PMID: 18221136. https://pubmed.ncbi.nlm.nih.gov/18221136/ Accessed September 7, 2021.



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    • In vivo data demonstrated response rate for ibrexafungerp similar to current standard of care options for the treatment of mucormycosis

    • Combination of ibrexafungerp with current therapies showed significant enhancement in median survival time and overall survival when compared with standard of care monotherapies

    JERSEY CITY, N.J., Oct. 11, 2021 (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 preclinical data supporting the potential of its broad-spectrum antifungal, ibrexafungerp, to treat mucormycosis. The data, based on an in vivo mouse model of mucormycosis, were presented…

    • In vivo data demonstrated response rate for ibrexafungerp similar to current standard of care options for the treatment of mucormycosis



    • Combination of ibrexafungerp with current therapies showed significant enhancement in median survival time and overall survival when compared with standard of care monotherapies

    JERSEY CITY, N.J., Oct. 11, 2021 (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 preclinical data supporting the potential of its broad-spectrum antifungal, ibrexafungerp, to treat mucormycosis. The data, based on an in vivo mouse model of mucormycosis, were presented at the 10th Trends in Medical Mycology (TIMM) meeting being held in-person in Aberdeen, Scotland, and virtually from October 8-11, 2021.

    The study, conducted at The Lundquist Institute at Harbor-University of California at Los Angeles (UCLA) Medical Center, evaluated in a mouse model the potential of ibrexafungerp for the treatment of mucormycosis caused by Rhizopus delemar (the most common cause of mucormycosis) and found that ibrexafungerp monotherapy demonstrated survival benefits equivalent to current standard of care treatments, including liposomal amphotericin B and posaconazole. Additionally, the study found when ibrexafungerp was combined with amphotericin B, synergistic benefits were observed with a significant enhancement in median survival time and overall survival when compared to any one therapy alone.

    "We are excited about the results of this study, which highlight ibrexafungerp's broad-spectrum activity and potential to be an integral component of future treatment strategies for severe and invasive fungal infections," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "Mucormycosis is a rare, life-threatening fungal infection with limited treatment options. The rapid surge in mucormycosis cases seen in India among patients diagnosed with COVID-19, particularly among those with diabetes, underscores the urgency to identify novel therapeutics to combat the disease and help people around the globe suffering from this terrible, deadly fungal infection."

    Cases of mucormycosis have increased significantly during the COVID-19 pandemic and the Central Government of India declared mucormycosis an epidemic on May 10, 2021. More than 47,500 cases have been reported and over 4,400 deaths were attributed directly to this type of fungal infection in India in the three months between May 5, 2021, and August 3, 2021.1,2

    "While the fungi that cause mucormycosis can be found in the environment and are harmless to most people, they can be deadly for those with weakened immune systems complicated by underlying conditions that have left them vulnerable to the infection," said study lead author Ashraf Ibrahim, Ph.D., FAAM, FECMM, an Investigator at The Lundquist Institute and Professor of Medicine, David Geffen School of Medicine, UCLA. "I'm encouraged by the findings from this study which demonstrate the potential for a new antifungal class to treat mucormycosis. I believe this work lays a strong foundation for future studies evaluating ibrexafungerp's potential to combat this often-lethal infection."

    The study was funded by the National Institutes of Health (NIH) utilizing the National Institute of Allergy and Infectious Diseases (NIAID) suite of preclinical services for in vivo testing. The presentation of findings, titled "Ibrexafungerp is effective in treating murine mucormycosis caused by Rhizopus delemar," can be accessed by TIMM meeting attendees via the meeting's online platform. More information on TIMM can be found here.

    About Mucormycosis

    Mucormycosis is an often life-threatening fungal infection that typically affects the nose, sinuses, eyes, and brain and is characterized by tissue necrosis and rapid progression.3 While multiple types of fungi can cause mucormycosis, R. delemar and R. oryae are the most common, accounting for ~70% of cases.4 Infections are most common in those with compromised immune systems, including those with cancer, diabetes or those taking steroid medications.1 The disease has an estimated 54% overall mortality rate.2

    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 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 IV and oral 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. 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. In addition, late-stage clinical investigation of ibrexafungerp for the prevention of recurrent Vulvovaginal Candidiasis (VVC) and the treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing. For more information, visit www.scynexis.com

    CONTACT: 

    Investor Relations

    Irina Koffler

    Managing Director

    LifeSci Advisors, LLC

    646-970-4681

    ikoffler@lifesciadvisors.com

    Media Relations

    Gloria Gasaatura

    LifeSci Communications

    646-970-4688

    ggasaatura@lifescicomms.com

    1 Akshay R, Nguyen TH, Rising incidence of mucormycosis in patients with COVID-19: another challenge for India amidst the second wave? Lancet, 2021 June, https://doi.org/10.1016/S2213-2600(21)00265-4 Accessed September 24, 2021.

    2 https://governmentstats.com/mucormycosis/index.html. Accessed October 1, 2021.

    3 Hernández JL, Buckley CJ. Mucormycosis. 2021 Jul 25. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2021 Jan–. PMID: 31335084. https://pubmed.ncbi.nlm.nih.gov/31335084/ Accessed September 24, 2021.

    4 Ribes JA, Vanover-Sams CL, Baker DJ. Zygomycetes in human disease. Clin Microbiol Rev. 2000 Apr;13(2):236-301. doi: 10.1128/CMR.13.2.236. PMID: 10756000; PMCID: PMC100153. https://pubmed.ncbi.nlm.nih.gov/10756000/ Accessed September 24, 2021.



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  2. JERSEY CITY, N.J., Oct. 07, 2021 (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 two poster presentations of interim data from its ongoing FURI and CARES studies, evaluating oral ibrexafungerp for the treatment of patients with refractory mucocutaneous and invasive fungal infections will be presented at the 10th Trends in Medical Mycology (TIMM) meeting being held virtually and in-person in Aberdeen, Scotland, October 8-11, 2021. In addition, pre-clinical data on ibrexafungerp for the treatment of mucormycosis will be shared in an oral presentation.

    "There are limited oral options effective…

    JERSEY CITY, N.J., Oct. 07, 2021 (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 two poster presentations of interim data from its ongoing FURI and CARES studies, evaluating oral ibrexafungerp for the treatment of patients with refractory mucocutaneous and invasive fungal infections will be presented at the 10th Trends in Medical Mycology (TIMM) meeting being held virtually and in-person in Aberdeen, Scotland, October 8-11, 2021. In addition, pre-clinical data on ibrexafungerp for the treatment of mucormycosis will be shared in an oral presentation.

    "There are limited oral options effective against multidrug-resistant pathogens in the hospital setting," said David Angulo, M.D., Chief Medical Officer, SCYNEXIS. "We hope to address this unmet need by advancing oral ibrexafungerp through these studies. It is part of our ongoing commitment to patients in the hospital setting, who are battling invasive and sometimes fatal fungal infections."

    Poster presentation details:

    • Outcomes of Oral Ibrexafungerp by Pathogen from Two Open-label Studies of Patients with Serious Fungal Infections (FURI and CARES) – Riina Richardson, D.D.S., Ph.D., FRCPath, The University of Manchester, England

      Poster #337

      Saturday, October 9, 2021

      6 am – 7 am ET
    • Oral Ibrexafungerp for Treatment of Patients with Refractory Mycoses: Interim Analysis of Outcomes from a Phase 3 Open-label Study (FURI) – Oliver A. Cornely, M.D., FECMM, FIDSA, FAAM, FACP, University of Cologne, Germany

      Poster #336

      Sunday, October 10, 2021

      6 am – 7 am ET

    Poster presentations will be accessible to meeting attendees via the TIMM program site. For more information on the Phase 3 FURI and CARES studies, visit ClinicalTrials.gov

    FURI (NCT03059992) and CARES (NCT03363841)

    Oral presentation details:

    • Ibrexafungerp is effective in treating murine mucormycosis caused by Rhizopus delemar – Ashraf Ibrahim, Ph.D., FAAM, FECMM, an Investigator at The Lundquist Institute and Professor of Medicine, David Geffen School of Medicine, UCLA

      Session: Symposium 16 Azoles, Echinocandins and Polyenes strengths and weaknesses

      Session #16.5

      Sunday, October 10, 2021

      9:15 am – 10:35 am ET

    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 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 IV and oral 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. 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. In addition, late-stage clinical investigation of ibrexafungerp for the prevention of recurrent Vulvovaginal Candidiasis (VVC) and the treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing. For more information, visit www.scynexis.com

    CONTACT: 

    Investor Relations

    Irina Koffler

    Managing Director

    LifeSci Advisors, LLC

    646-970-4681 (w)

    ikoffler@lifesciadvisors.com

    Media Relations

    Gloria Gasaatura

    LifeSci Communications

    646-970-4688

    ggasaatura@lifescicomms.com



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  3. WASHINGTON, Sept. 30, 2021 /PRNewswire/ -- The Antimicrobials Working Group (AWG), a coalition of companies with the mission to combat drug resistant infections and spur life-saving innovations, today announced that 10 of its member companies will present data from their clinical and research programs at IDWeek 2021 taking place virtually from September 29-October 3, 2021. AWG members are presenting a total of 23 poster presentations and 3 oral abstract presentations.

    IDWeek is the joint annual meeting of the Infectious Diseases Society of America (IDSA), Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), the Pediatric Infectious Diseases Society (PIDS), and the Society of Infectious Diseases Pharmacists…

    WASHINGTON, Sept. 30, 2021 /PRNewswire/ -- The Antimicrobials Working Group (AWG), a coalition of companies with the mission to combat drug resistant infections and spur life-saving innovations, today announced that 10 of its member companies will present data from their clinical and research programs at IDWeek 2021 taking place virtually from September 29-October 3, 2021. AWG members are presenting a total of 23 poster presentations and 3 oral abstract presentations.

    IDWeek is the joint annual meeting of the Infectious Diseases Society of America (IDSA), Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), the Pediatric Infectious Diseases Society (PIDS), and the Society of Infectious Diseases Pharmacists (SIDP).

    "AWG is thrilled to be so well represented at this year's IDWeek conference," said Ted Schroeder, Chief Executive Officer of Nabriva Therapeutics and Chairman of AWG. "The COVID-19 pandemic has provided a stark reminder of the need for preparedness against emerging infectious disease threats, not the least of which includes supporting innovation of safe and effective antimicrobials for dangerous, and hard to treat, drug-resistant pathogens. Presentations from AWG member companies will highlight the latest developments in the fight against superbugs and drug resistant infections."

    For more information on AWG member company posters and participation please visit: https://antimicrobialsworkinggroup.org/idweek-2021/

    About The Antimicrobials Working Group

    AWG was founded in 2012 with the vision of utilizing collective power to improve the regulatory, investment, and commercial environment for emerging infectious disease companies. Today, AWG is comprised of fourteen antimicrobials companies: Acurx Pharmaceuticals, Inc. (NASDAQ:ACXP), Cidara Therapeutics Inc. (NASDAQ:CDTX), CorMedix, Inc., Crestone, Inc., Entasis Therapeutics Inc., Iterum Therapeutics Ltd. (NASDAQ:ITRM), Melinta Therapeutics Inc. (NASDAQ:MLNT), Nabriva Therapeutics US Inc. (NASDAQ:NBRV), Paratek Pharmaceuticals Inc. (NASDAQ:PRTK), Qpex Biopharma, Inc., SCYNEXIS Inc. (NASDAQ:SCYX), Summit Therapeutics plc (NASDAQ:SMMT) (AIM: SUMM), UTILITY therapeutics Ltd., and Venatorx Pharmaceuticals, Inc.

    For more information, visit: www.antimicrobialsworkinggroup.org

    About The Conafay Group

    The Conafay Group, led by Stephen R. Conafay, Principal, is a life-sciences government relations firm based in Washington D.C. that serves as Washington counsel and coalition manager for AWG.

    For more information, visit: www.conafaygroup.com

    Media Contact: conafay@conafaygroup.com

    Cision View original content:https://www.prnewswire.com/news-releases/antimicrobials-working-group-highlights-member-company-participation-at-idweek-2021-301388427.html

    SOURCE Antimicrobials Working Group (AWG)

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