Skip to main content

SCYNEXIS Announces Advancement of Ibrexafungerp’s Intravenous Formulation to Clinical Stage and Provides Further Updates on its Clinical Studies in Patients with Life-Threatening Fungal Infections

Approval granted by health authority for the intravenous (IV) formulation of ibrexafungerp to enter Phase 1; dosing in healthy volunteers to start in the first quarter of 2021New interim analysis of the data from the Phase 3 studies of ibrexafungerp in refractory invasive fungal infections (FURI and CARES) expected in the first quarter of 2021; additional 43 patients will double the existing dataset of 41 cases already analyzedAnalysis of the CARES study will provide the first clinical trial data of an investigational treatment against infections caused by Candida auris, a multidrug-resistant fungus deemed an urgent threat by the CDC
JERSEY CITY, N.J., Dec. 10, 2020 (GLOBE NEWSWIRE) — SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced significant progress on the ibrexafungerp IV formulation and provided an update on its ongoing Phase 3 studies in the hospital setting.(1)  Liposomal IV formulation of ibrexafungerp entering Phase 1 study(2)  New interim analysis of Phase 3 FURI and CARES open-label studies expected in the first quarter of 2021, doubling the existing dataset of patient cases“As we prepare for our first commercial launch of oral ibrexafungerp in the community setting in 2021, we are also excited about advancing ibrexafungerp for patients with serious and life-threatening infections in the hospital setting,” said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. “The analysis of our CARES study will provide the first clinical trial data of an investigational treatment against Candida auris, a multidrug-resistant fungus deemed an urgent threat by the CDC. When approved, ibrexafungerp would represent the first new antifungal class in over 20 years and, with the advancement of our IV formulation, ibrexafungerp could become the first new class offering the flexibility of both IV and oral formulations in over 40 years.”About SCYNEXISForward Looking StatementStatements 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, including but not limited to statements regarding SCYNEXIS’s expected timing of dosing of volunteers and patients and reporting of interim analyses. 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 obtain regulatory approval to commence dosing of ibrexafungerp; SCYNEXIS’s need for additional capital resources; and SCYNEXIS’s reliance on third parties to conduct SCYNEXIS’s clinical studies. 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 and Form 10-Q 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
Irina Koffler
LifeSci Advisors
Tel: (646) 970-4681
ikoffler@lifesciadvisors.com
Media Relations
Gloria Gasaatura
LifeSci Communications
Tel: (646) 970-4688
ggasaatura@lifescicomms.com

Disclaimer & Cookie Notice

Welcome to GOLDEA services for Professionals

Before you continue, please confirm the following:

Professional advisers only

I am a professional adviser and would like to visit the GOLDEA CAPITAL for Professionals website.

Important Notice for Investors:

The services and products offered by Goldalea Capital Ltd. are intended exclusively for professional market participants as defined by applicable laws and regulations. This typically includes institutional investors, qualified investors, and high-net-worth individuals who have sufficient knowledge, experience, resources, and independence to assess the risks of trading on their own.

No Investment Advice:

The information, analyses, and market data provided are for general information purposes only and do not constitute individual investment advice. They should not be construed as a basis for investment decisions and do not take into account the specific investment objectives, financial situation, or individual needs of any recipient.

High Risks:

Trading in financial instruments is associated with significant risks and may result in the complete loss of the invested capital. Goldalea Capital Ltd. accepts no liability for losses incurred as a result of the use of the information provided or the execution of transactions.

Sole Responsibility:

The decision to invest or not to invest is solely the responsibility of the investor. Investors should obtain comprehensive information about the risks involved before making any investment decision and, if necessary, seek independent advice.

No Guarantees:

Goldalea Capital Ltd. makes no warranties or representations as to the accuracy, completeness, or timeliness of the information provided. Markets are subject to constant change, and past performance is not a reliable indicator of future results.

Regional Restrictions:

The services offered by Goldalea Capital Ltd. may not be available to all persons or in all countries. It is the responsibility of the investor to ensure that they are authorized to use the services offered.

Please note: This disclaimer is for general information purposes only and does not replace individual legal or tax advice.