- BARDA seeks to support the development of broad-spectrum oral/IV antifungal drug candidates with novel targeted mechanisms of action. Candida Race, include candida auris, When Aspergillus Race.
- A first-in-class broad-spectrum oral/IV antifungal agent, Ibrexafungerp meets all the priorities outlined in the new Broad Authority Announcement (BAA) announced this week by BARDA, and is effective against multiple drug-resistant pathogens, including: shows activity. C. auris, C. albicans, C. glabrata, C. parapsilosis When C. tropicaliseven as Aspergillus fumigatus, Histoplasma seed.When Mucorales.
JERSEY CITY, N.J., Nov. 17, 2022 (GLOBE NEWSWIRE) — SCYNEXIS, Inc. (NASDAQ: SCYX) is a pioneer of innovative medicines to overcome and prevent difficult-to-treat drug-resistant infections. A biotech company that is a global company, today we applauded your actions. This week, the Biomedical Advanced Research and Development Authority (BARDA) announced the development of antifungal medical countermeasures (MCMs) to treat infections caused by the threat of drug-resistant fungi in its new Broad Agency Announcement (BAA) Area of Interest. I took it to add to BARDA announced this week for the first time that it is seeking partnerships to develop broad-spectrum, next-generation antifungals to treat high-priority fungal infections.
Marco Taglietti, M.D., President and CEO of SCYNEXIS, said: “Ibrexaphan gelp has promising activity against multidrug-resistant bacteria and high-fat fungal infections, and has great potential to benefit patients with severe fungal diseases and limited treatment options. As a leader in the antifungal field with multiple ongoing Phase 3 trials, SCYNEXIS is well-positioned to respond to BARDA’s call to action and deliver an innovative and potent antifungal agent. We are pleased with the continued clinical progress as we remain committed to bringing it to market as a potential option for patients with difficult-to-treat fungal infections.”
The announcement on the growing focus on developing antifungal therapeutics was made at the BARDA Industry Day (BID), November 15-16, 2022. This is an annual conference on continued innovation and progress in MCM development and ongoing collective efforts to support readiness against chemical and biological countermeasures. , radiation and nuclear (CBRN) threats, pandemic influenza, and emerging infectious diseases. According to the BARDA BAA, priorities include drug candidates representing first-in-class antifungal agents with novel mechanisms of action or drug candidates with improved formulations or alternative delivery regimens (such as oral and intravenous administration). included.
The call to action follows the World Health Organization’s (WHO) release in October of its first report highlighting a list of fungal “priority pathogens” that pose the greatest threat to public health. The WHO list of dangerous pathogens includes well-known pathogens such as: Candida auris (C. auris) others Candida species such as C. albicans, C. glabrata, C. parapsilosis When C. tropicaliseven as Aspergillus fumigatus, Histoplasma seed.When Mucorales.
SCYNEXIS Chief Medical Officer David Angulo, MD, said: “Data from our Phase 3 FURI and CARES trials provide evidence of clinical activity for ibrexaphan gelp against serious and difficult-to-treat fungal infections that are refractory to currently available therapies. This week’s BARDA news and WHO call to action are further validation of our corporate strategy to focus on life-threatening invasive fungal infections.At SCYNEXIS, with ibrexafungerp, we are at the forefront of this effort against antibiotic-resistant pathogens. I am proud to be fighting an endless war.”
About Ibrexaphangelp
ibrexaphan gelp [pronounced eye-BREX-ah-FUN-jerp] It is an antifungal agent and the first representative of a new class of structurally distinct glucan synthase inhibitors, the triterpenoids. This drug combines the well-established activity of a glucan synthase inhibitor with the potential flexibility of having oral and intravenous (IV) formulations. Ibrexafungerp is in late-stage research and development for multiple indications, including life-threatening fungal infections. Candida (include C. auris) When Aspergillus Inpatient Species. Broad-spectrum antifungal activity has been demonstrated. in vitro When in vivo, against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains. The FDA has granted oral and IV formulations of ibrexaphan gelp Qualified Infectious Disease Products (QIDP) and FAST for the indications of invasive candidiasis (IC) and invasive aspergillosis (IA), including candidaemia. Granted Track Designation and granted Orphan Drug Designation for IC. and IA display. The European Medicines Agency (EMA) has granted ibrexaphan gelp orphan drug designation for the indication of IC. Ibrexafungerp was formerly known as SCY-078.
About Cynexis
SCYNEXIS, Inc. (NASDAQ: SCYX) is a biotechnology company and innovative biotechnology company helping millions of patients around the world overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant. developing pharmaceuticals. SCYNEXIS scientists have identified the company’s lead asset, ibrexafungerp (previously known as his SCY-078), as a broad-spectrum systemic antifungal agent for multiple fungal indications in both community and hospital settings. ) are being developed. SCYNEXIS launched his BREXAFEMME® (ibrexafungerp tablets), the first commercial product in the United States. The U.S. Food and Drug Administration (FDA) approved his BREXAFEMME on June 1, 2021. SCYNEXIS has filed a Supplemental New Drug Application (sNDA) to extend BREXAFEMME labeling to include prevention of recurrence of vulvovaginal candidiasis, and the FDA has set a target action date for his PDUFA to November 30, 2022, to this end. Added efficacy. Additionally, late-stage clinical studies of oral ibrexaphan gelp for the treatment of life-threatening invasive fungal infections in hospitalized patients are ongoing. For more information, please visit www.scynexis.com.
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Cynexis
Debbie.etchison@scynexis.com
