SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company delivering innovative therapies for difficult-to-treat and often life-threatening infections, today announced data demonstrating the potential use of ibrexafungerp as an agent to address multiple serious fungal infections, including many that have shown resistance to existing therapies.
| JERSEY CITY, N.J., April 3, 2019 /PRNewswire/ -- SCYNEXIS, Inc.. (NASDAQ: SCYX), a biotechnology company delivering innovative therapies for difficult-to-treat and often life-threatening infections, today announced data demonstrating the potential use of ibrexafungerp as an agent to address multiple serious fungal infections, including many that have shown resistance to existing therapies. The collection of data will be presented in one oral and five poster presentations at the 29th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), April 13-16, 2019, in Amsterdam, Netherlands. “We are pleased and proud to have a total of six presentations, including three late-breakers, accepted by ECCMID 2019, contributing to a growing body of evidence supporting the strong clinical activity of oral ibrexafungerp in difficult-to-treat and resistant Candida infections and its versatility in addressing unmet needs in multiple settings,” said David Angulo, M.D., Chief Medical Officer of SCYNEXIS. “Our ability to enroll and successfully treat patients in the FURI and CARES studies shows that there is a clear unmet medical need for a novel and more potent antifungal therapy, particularly an oral agent, to treat patients with these devastating fungal infections.” Ibrexafungerp, the first representative of a novel family of compounds referred to as “fungerps” (antifungal triterpenoids), is being developed for oral and intravenous (IV) administration and is in clinical development for the treatment of several serious fungal infections, including vulvovaginal candidiasis (VVC), invasive candidiasis (IC), invasive aspergillosis (IA) and refractory invasive fungal infections. ECCMID, as one of the world’s premier clinical microbiology and infectious disease events, brings together experts to present their latest findings, guidelines and experiences. Details of the six ibrexafungerp presentations are as follows: Oral Presentation Title: Favorable Response to Oral Ibrexafungerp (formerly SCY-078) in Patients with Refractory Fungal Diseases, Interim Analysis by Pathogen from a Phase 3 Open-label Study (FURI) The presentation showcases results from the first interim analysis of 20 patients with various Candida infections from the FURI study, an open-label trial of oral ibrexafungerp in patients with refractory fungal infections. 11 patients (55%) achieved complete or partial response, 6 patients (30%) maintained stable disease, 2 patients (10%) experienced progression of disease and one case was considered as indeterminate. Of particular interest, the patients enrolled in the FURI study predominantly had non-albicans Candida spp. infections, which are more resistant and difficult-to-treat with current marketed antifungal agents, reflecting the need for new antifungal therapies. Poster Presentations Title: Successful Treatment of Two Patients with Candida auris Candidemia with the Investigational Agent, Oral Ibrexafungerp (formerly SCY-078) from the CARES Study The poster presents clinical findings of two patients with Candida auris candidemia enrolled in the CARES study, who were successfully treated with oral ibrexafungerp. Both patients had multiple co-morbidities, were admitted to ICU and were diagnosed with Candida auris in the bloodstream, a pathogen defined by the Center of Disease Control (CDC) as “an emerging fungus that presents a serious global health threat.” Both of these difficult-to-treat candidemia cases responded positively to oral ibrexafungerp, with clearance of the C. auris infection at the end of treatment. Ibrexafungerp was well-tolerated by both patients. Title: Favourable Clinical Outcome of Two Patients with Candida spp. Spondylodiscitis Treated with Oral Ibrexafungerp (formerly SCY-078) from the FURI Study The poster presents two patients with Candida spondylodiscitis, a rare and difficult-to-treat infection of the intervertebral disc space and vertebral bone that requires months-long courses of therapy. Both patients were enrolled into the FURI study, with one patient being intolerant to azole therapy and the other patient failing standard therapy. The patients have received >290 days and >100 days of ibrexafungerp therapy, with one patient showing significant improvement and one complete resolution. Long-term treatment with ibrexafungerp has been well tolerated by these patients. Title: Use of Ibrexafungerp (formerly SCY-078) to Treat Severe Azole-refractory Oesophageal Candidiasis: A Case Report from the FURI Study The poster presents a patient from the FURI study, a 63-year-old male with a 10-year history of painful esophageal constriction and recurrent esophageal candidiasis, requiring a percutaneous gastroenterostomy feeding tube due to his inability to swallow and eat. Multiple courses of antifungals were unsuccessful in treating this fluconazole-resistant C. glabrata infection, and the patient was enrolled in the FURI study with severe esophagitis at baseline. After 54 days of oral ibrexafungerp treatment, the infection fully resolved. The patient remained asymptomatic during the follow-up period and the feeding tube was able to be removed. Title: Penetration of Ibrexafungerp (formerly SCY-078) versus Micafungin at the Site of Infection in an Intra-abdominal Candidiasis Mouse Model The oral E-poster presents results from a study designed to test ibrexafungerp’s penetration in a mouse model of intra-abdominal candidiasis (IAC). IAC is a common invasive fungal infection with high mortality. Echinocandins, the current gold standard for treatment for invasive candidiasis, are not ideal treatment options for IAC given their poor penetration into intra-abdominal tissue and abscesses. In this study, Perlin et al., showed that ibrexafungerp penetrates significantly better into intra-abdominal abscesses as compared to micafungin. It holds promise as a potential therapeutic option for IAC patients. Title: Efficacy of Ibrexafungerp (formerly SCY-078) against Pneumocystis Pneumonia in a Murine Therapeutic Model The oral E-poster presents results from an in vivo study designed to evaluate the therapeutic activity of oral ibrexafungerp against Pneumocystis pneumonia (PCP), a significant risk for immunocompromised patients. Oral ibrexafungerp was evaluated at two dose levels (15mg/kg or 30mg/kg, twice daily), compared to trimethoprim/sulfamethoxazole 50/250mg/kg three times weekly, the current standard of care, and vehicle control. At each dose level, oral ibrexafungerp demonstrated activity against Pneumocystis, as determined by a reduction in organism burden and improved survival, supporting future clinical studies of ibrexafungerp for both treatment of PCP and prophylactic use as a single oral agent in immunocompromised patients. The ECCMID 2019 posters will be available on the SCYNEXIS website following the event and on the ECCMID 2019 website. About SCYNEXIS Forward Looking Statement CONTACT: Media Relations SOURCE SCYNEXIS, Inc. | ||
Company Codes: NASDAQ-NMS:SCYX |
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