SCYNEXIS's Ibrexafungerp Shows Favorable Clinical Activity in Resistant Fungal Infections, Including Candida auris Cases from the CARES Study, in Data to be Presented at the 29th ECCMID
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.
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)
Presenter: Oliver Cornely, MD
Date and Time: Tuesday, April 16, from 11:00-12:00 CET
Oral Presentation #: L0010
Session: Recent clinical trials
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
Presenter: Deven Juneja, MD
Date and Time: Saturday, April 13, from 15:30-16:30 CET
Poster Presentation #: L0028
Session: Other issues and diverse late breaker aspects
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
Presenter: Philipp Koehler, MD
Date and Time: Saturday, April 13, from 15:30-16:30 CET
Poster Presentation #: L0033
Session: Other issues and diverse late breaker aspects
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
Presenter: Jose Vazquez, MD
Date and Time: Saturday, April 13, from 15:30-16:30 CET
Poster Presentation #: P0125
Session: Clinical pharmacokinetics, treatment strategies and prescribing of antifungals
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
Presenter: Annie Lee, PhD
Date and Time: Monday, April 15, from 11:42-11:47 CET
Poster Presentation #: O0740
Session: Antifungals: novel drugs, novel dosing?
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
Presenter: Stephen Barat, PhD
Date and Time: Monday, April 15, from 11:00-11:05 CET
Poster Presentation #: O0733
Session: Antifungals: novel drugs, novel dosing?
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
SCYNEXIS, Inc. (NASDAQ:SCYX) is a biotechnology company committed to positively impacting the lives of patients suffering from difficult-to-treat and often life-threatening infections by developing innovative therapies. The SCYNEXIS team has extensive experience in the life sciences industry, having discovered and developed more than 30 innovative medicines over a broad range of therapeutic areas. SCYNEXIS's lead product candidate, ibrexafungerp (formerly known as SCY-078), is a novel IV/oral antifungal agent in Phase 3 clinical and preclinical development for the treatment of multiple serious and life-threatening invasive fungal infections caused by Candida, Aspergillus and Pneumocystis species. For more information, visit www.scynexis.com.
Forward Looking Statement
Statements contained in this press release regarding expected future events or results are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks inherent in SCYNEXIS's ability to successfully develop and obtain FDA approval for ibrexafungerp. These and other risks are described more fully in SCYNEXIS's filings with the Securities and Exchange Commission, including without limitation, its most recent Annual Report on Form 10-K under the caption "Risk Factors" and other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. SCYNEXIS undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
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