SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company delivering innovative therapies for difficult-to-treat and often life-threatening infections, today announced that data, which further demonstrates the potential of ibrexafungerp as a treatment for invasive fungal infections, will be presented at IDWeek 2019, occurring October 2-6, 2019 in Washington DC, and TIMM-9, occurring October 11-14, 2019 in Nice, France
| JERSEY CITY, N.J., Oct. 2, 2019 /PRNewswire/ -- SCYNEXIS, Inc., (NASDAQ: SCYX), a biotechnology company delivering innovative therapies for difficult-to-treat and often life-threatening infections, today announced that data, which further demonstrates the potential of ibrexafungerp as a treatment for invasive fungal infections, will be presented at IDWeek 2019, occurring October 2-6, 2019 in Washington DC, and TIMM-9, occurring October 11-14, 2019 in Nice, France. Ibrexafungerp (formerly SCY-078), the first representative of a novel triterpenoid antifungal family being developed for oral and intravenous (IV) usage, is in clinical development for the treatment of multiple serious fungal infections, including many that have shown resistance to existing therapies. “When the Centers for Disease Control and Prevention (CDC) first alerted the public in 2016 of the threat Candida auris posed as a dangerous and emerging global pathogen, we immediately began evaluating the activity of ibrexafungerp against Candida auris through multiple in vitro, in vivo and clinical studies,” said Dr. David Angulo, Chief Medical Officer of SCYNEXIS. “To our knowledge, ibrexafungerp is the first new experimental antifungal to be tested in patients with Candida auris infections, and the data so far indicates ibrexafungerp’s high activity against this deadly pathogen. We continue to advance this important new therapy through our ongoing clinical studies and look forward to sharing those results in our effort to address these difficult-to-treat infections.” Details for the upcoming presentations are as follows: IDWeek 2019 Title: Activity of Ibrexafungerp (formerly SCY-078) Against Candida auris: In Vitro, In Vivo and Clinical Case Studies of Candidemia This poster will highlight a large body of evidence demonstrating the activity and effectiveness of ibrexafungerp against Candida auris. In vitro studies tested ibrexafungerp against >100 clinical isolates of C. auris and evaluated the effects of ibrexafungerp against C. auris biofilms. In vivo activity against C. auris was evaluated using a disseminated murine model and a cutaneous infection guinea pig model. In humans, an ongoing open-label trial of oral ibrexafungerp for treatment of patients with infections caused by C. auris (the CARES study) is ongoing in the U.S. and India. 9th Trends in Medical Mycology (TIMM 2019) Oral Presentation Title: Ibrexafungerp (formerly SCY-078) Session: Symposium 11, The Anti-fungal Pipeline This oral presentation will focus on antifungal agents currently being developed. Ibrexafungerp is one of three products presented during this session. The presentation will highlight oral ibrexafungerp’s studies that demonstrate its broad-spectrum of activity against Candida, Aspergillus and Pneumocystis, along with its activity against resistant organisms and development pathway of oral ibrexafungerp for treatment of hospital-treated fungal infections in patients with resistant and refractory infections, including Candida auris. Poster Presentations Title: Candida auris is Highly In Vitro Susceptible to Ibrexafungerp (Formerly SCY-078) in EUCAST Antifungal Susceptibility Testing Candida auris is a multidrug-resistant yeast rapidly emerging as a significant cause of nosocomial infections. This poster will present data on an in vitro study testing the activity of ibrexafungerp against 122 clinical C. auris isolates (from India (n=120) and Oman (n=2)). The in vitro activity of ibrexafungerp (IBX) against C. auris was uniform with MICs displaying a Gaussian distribution spanning 0.06-2 mg/L suggesting an equal efficacy across the 122 isolates. In contrast, MIC distributions for anidulafungin, micafungin, isavuconazole, voriconazole, itraconazole and posaconazole were wide (spanning 10-13 dilutions) suggesting differential activity against the isolates. Ibrexafungerp, a novel oral glucan synthase inhibitor, shows promising in vitro activity against C. auris, suggesting it may be a welcomed therapeutic against this emerging threat with few treatment options. Presenter: George R. Thompson III, MD This poster presentation will highlight a single case of a patient with an intra-abdominal fungal infection treated with oral ibrexafungerp from the FURI study. The case presents a 71-year old male patient with ischemic stroke, pulmonary edema, and tracheostomy, treated for a retroperitoneal abscess, a complication of a perforated duodenal ulcer. Candida krusei was isolated in peri-duodenal drain cultures and the patient was initiated on micafungin therapy for 21 days but remained culture positive. Micafungin therapy was terminated, the patient was enrolled in the FURI study and ibrexafungerp was initiated for a total of 21 days of therapy. Clinical improvement was observed during therapy. At the End-of-Treatment visit, the clinical signs and symptoms of fungal disease were considered by the investigator to be resolved. No drug-related adverse events were reported. Presenter: David Angulo, MD This poster will highlight the current in vitro, in vivo and two clinical cases for ibrexafungerp against Candida auris. In vitro and in vivo studies demonstrated that ibrexafungerp is active against C. auris, including multidrug-resistant (MDR) strains. The MIC mode for ibrexafungerp was 1ug/ml and the MIC50 and MIC90 were 0.5 and 1 ug/ml, respectively. Many echinocandin-resistant C. auris isolates have shown susceptibility to ibrexafungerp. Further, ibrexafungerp has been shown to reduce biofilm thickness. In animal models of C. auris infection, treatment with ibrexafungerp resulted in improved survival and reduced fungal burden in both the murine model of disseminated infection and the guinea pig model of cutaneous infection as compared to untreated controls. In humans, two patients with difficult to treat C. auris candidemias were enrolled in the CARES study and responded positively to oral ibrexafungerp with eradication of the infection. The IDWeek 2019 and TIMM-9 presentations will be available on the SCYNEXIS website accordingly following each event. About Ibrexafungerp About the FURI and CARES Studies
In both studies, patients are also considered for enrollment if they have an eligible fungal disease and, in the judgement of the investigator, cannot receive approved oral antifungal options (e.g., susceptibility of the organism or risk for drug-drug interactions) and continued IV antifungal therapy is not desirable or feasible due to clinical or logistical circumstances. Enrolled patients receive an initial loading dose of 750mg BID (twice a day) of oral ibrexafungerp during the first two days of treatment and subsequent oral doses of 750mg QD (once a day) for up to 90 days. Patients are evaluated several times during treatment, with treatment efficacy assessed at the end of ibrexafungerp therapy. Subjects are then followed for another six weeks. The open-label designs of the FURI and CARES studies allow for evaluation of the data on an interim basis to further inform subsequent regulatory steps of the development program. SCYNEXIS believes that compelling data from the FURI and/or CARES studies could allow ibrexafungerp to become eligible for the regulatory Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD), potentially resulting in an NDA submission based on streamlined development. The LPAD was established under the 21st Century Cures Act of 2016, and FDA draft guidance issued in June 2018 suggests smaller, shorter or fewer clinical trials may be sufficient to support approval to treat a serious or life-threatening infection in a limited population with unmet needs. More information about the studies can be found at:
About SCYNEXIS Forward Looking Statement CONTACT: Investor Relations Media Relations SOURCE SCYNEXIS, Inc. | ||
Company Codes: NASDAQ-NMS:SCYX |
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