World-renowned Fungal Infection Expert Comments on Oral Ibrexafungerp Data Presented by SCYNEXIS at ASM Microbe 2019

Download as PDF

"Oral ibrexafungerp has demonstrated nonclinical and clinical success in difficult-to-treat fungal infections"

"Preclinical data shows oral ibrexafungerp's potential role in controlling Candida auris"

"Supporting data shows the potential of oral ibrexafungerp as a broad-spectrum antifungal, allowing for a single-agent prophylactic regimen"

JERSEY CITY, N.J., June 25, 2019 /PRNewswire/ -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company delivering innovative therapies for difficult-to-treat and often life-threatening infections, today announced the availability of nine presentations (here) from the American Society for Microbiology (ASM) Microbe 2019, which occurred June 20-24, 2019, in San Francisco. 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.

"Oral ibrexafungerp's potential to address areas of significant unmet medical need is highlighted by the data presented at ASM Microbe," said Luis Ostrosky-Zeichner, MD, a renowned fungal infection expert and investigator in SCYNEXIS' ongoing FURI and SCYNERGIA trials. Dr. Ostrosky-Zeichner is Professor of Medicine and Epidemiology and Vice Chair for Healthcare Quality for the Department of Medicine, UT Health and McGovern Medical School at the University of Texas. He is also the Director of the Laboratory of Mycology Research at the Division of Infectious Diseases. He has advanced training and experience in medical mycology, hospital epidemiology, transplant infectious diseases and healthcare quality.

Dr. Ostrosky-Zeichner is also an editor for Journal of Antimicrobial Chemotherapy and editorial board member of Antimicrobial Agents and Chemotherapy. He has served as a consultant to the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), is a board member of the Mycoses Study Group and the Immunocompromised Host Society, and previously served on and chaired the Infectious Diseases Society of America (IDSA) Guidelines Committee.

Dr. Ostrosky-Zeichner's comments regarding the significance of the data and the potential impact ibrexafungerp could have in clinical practice for the treatment and prevention of fungal infections follow:

  • On his presentation of the FURI interim analysis:

"The data shows that oral ibrexafungerp provides a valuable treatment option in difficult-to-treat fungal infections for patients intolerant of or refractory to current standard-of-care antifungal treatments, including IV regimens. I cannot stress enough the benefit to patients and the importance to clinicians of a new antifungal class that could treat these severe infections while also allowing for oral outpatient therapy."

  • On the intra-abdominal candidiasis mouse model presented by Yanan Zhao, PhD:

"The model demonstrates the ability of oral ibrexafungerp to penetrate into intra-abdominal abscesses. Intra-abdominal Candida infections are often difficult to treat due to inadequate penetration of antifungals into the abscess. In this animal model, orally administered ibrexafungerp showed superior penetration versus IV echinocandins, the current standard-of-care. An oral antifungal agent achieving high concentrations in the intra-abdominal site of infection may provide better outcomes to manage these infections, which often require long treatment regimens."

  • On the activity of ibrexafungerp against Candida auris presented by Mahmoud Ghannoum, PhD:

"Candida auris is a newly identified fungal pathogen that is often multidrug-resistant with almost all isolates resistant to fluconazole. C. auris is a serious public health threat as it can result in high mortality rates and can cause outbreaks in healthcare settings. Dr. Ghannoum's two animal model presentations show 1) oral ibrexafungerp's activity in a systemic C. auris infection, and 2) oral ibrexafungerp's ability to reduce the C.auris fungal burden in the skin. The ability of ibrexafungerp to kill C. auris from the skin can be particularly relevant in light of the results from a CDC-led study (here), also presented at ASM, showing that residents in a skilled long-term care facility were colonized with C. auris on the skin and that skin shedding may play an important role in the transmission of C. auris from patient to the environment and consequently to other residents in a healthcare facility. Altogether, these results emphasize the potential utility of ibrexafungerp to address this emerging pathogen, including skin colonization, which may be associated with the spread of C. auris both in the healthcare setting and potentially in the community."

  • On the data showing ibrexafungerp's activity against Pneumocystis pneumonia presented by Stephen Barat, PhD:

"Pneumocystis is an important organism responsible for infections in immunocompromised patients, such as those with HIV, transplant, leukemia or on high-dose steroids. Currently, many of these patients receive prophylaxis treatment consisting of an azole to prevent Candida and Aspergillus infections in combination with trimethoprim/sulfamethoxazole to address Pneumocystis. As a single oral agent covering all three organisms, oral ibrexafungerp would be a welcome addition to the armamentarium of infection disease specialists and would simplify the regimen for patients who may require prophylactic treatment for an extended period of time."

"Overall, these presentations demonstrate ibrexafungerp's significant potential to positively impact future clinical practice in the treatment and prevention of fungal infections, and I look forward to continuing my participation in ibrexafungerp's clinical studies and supporting the development of this investigational agent," concluded Dr. Ostrosky-Zeichner.

Below are the ASM Microbe 2019 presentations:

Oral Presentations

Poster Presentations

Dr. Ostrosky-Zeichner is an advisor to SCYNEXIS and an investigator in clinical trials evaluating ibrexafungerp. Dr. Ostrosky-Zeichner is not a SCYNEXIS shareholder.

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.

CONTACT: 
Investor Relations
Heather Savelle
Argot Partners
Tel: 212-600-1902
heather@argotpartners.com

Media Relations
George E. MacDougall
MacDougall
Tel: 781-235-3093
george@macbiocom.com

 

Cision View original content:http://www.prnewswire.com/news-releases/world-renowned-fungal-infection-expert-comments-on-oral-ibrexafungerp-data-presented-by-scynexis-at-asm-microbe-2019-300873940.html

SOURCE SCYNEXIS, Inc.

Released June 25, 2019