Caspofungin Acetate

Publication reaffirms the efficacy of rezafungin for treatment of candidemia and invasive candidiasis (IC) in adult patients across Candida species PARSIPPANY, N.J.--(BUSINESS WIRE)-- Melinta Therapeutics, LLC today announced the peer-reviewed publication of data from the completed ReSTORE phase 3 global clinical trial evaluating REZZAYO® (rezafungin for injection) for the treatment of candidemia and invasive candidiasis (IC) in adults. The data analyses in the article, “Outcomes by Candida spp. in the ReSTORE Phase 3 trial of rezafungin versus caspofungin for candidemia and/or invasive candidiasis,” published in the American Society for Microbiology Antimicrobial Agents and Chemotherapy, demonstrates the efficacy of rezafungin in adult patients across a variety of Candida species. Rates of global cure and mycological eradication at day 14 and all-cause mortality at day 30 were generally comparable between the two treatment groups. The article additionally highlights the approval of the Clinical and Laboratory Standards Institute (CLSI) susceptibility breakpoints for rezafungin against several Candida species including Candida glabrata, a species increasingly associated with reduced susceptibility to treatment with echinocandins, and Candida auris, a highly resistant pathogen that is associated with life-threating infections. Rezafungin is the only antifungal, based on in vitro data, that has a defined susceptibility breakpoint for C. auris approved by CLSI; the efficacy of rezafungin in treating candidemia or invasive candidiasis caused by this pathogen has not been established in adequate and well-controlled clinical trials. Christine Ann Miller, president and chief executive officer of Melinta Therapeutics, said, "We are delighted with the release of this analysis of data from the ReSTORE Phase 3 trial, which supports the effectiveness and safety of REZZAYO in comparison to caspofungin and are also pleased to see that CLSI approved the REZZAYO susceptibility breakpoints for Candida pathogens, including C. auris, which has been identified as a potential global threat by the CDC and WHO.” She added, "Melinta has been leveraging our expertise in hospital and acute care environments to commercialize REZZAYO, making it available to healthcare providers and their patients affected by candidemia and invasive candidiasis. This effort supports our mission to provide innovative therapies to people impacted by acute and life-threatening illnesses." Melinta holds the exclusive rights to commercialize rezafungin in the U.S. from Mundipharma. About REZZAYO® (rezafungin for injection) REZZAYO (rezafungin for injection) is a novel once weekly echinocandin approved in the United States for the treatment of candidemia and invasive candidiasis in adults. REZZAYO is currently being studied for the prevention of invasive fungal diseases in adults undergoing allogeneic blood and marrow transplantation. INDICATIONS AND USE REZZAYO is an echinocandin antifungal indicated in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis. Approval of this indication is based on limited clinical safety and efficacy data. REZZAYO has not been studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida. IMPORTANT SAFETY INFORMATION Contraindications REZZAYO is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins. Warnings and Precautions Infusion-related Reactions: REZZAYO may cause infusion-related reactions, including flushing, sensation of warmth, urticaria, nausea, or chest tightness. If these reactions occur, slow or pause the infusion. Photosensitivity: REZZAYO may cause photosensitivity. Advise patients to use protection from sun exposure and other sources of UV radiation. Hepatic Adverse Reactions: Abnormalities in liver tests have been seen in clinical trial patients treated with REZZAYO. Monitor patients who develop abnormal liver tests and evaluate patients for their risk/benefit of continuing REZZAYO therapy. Adverse Reactions Most common adverse reactions (incidence ≥ 5%) are hypokalemia, pyrexia, diarrhea, anemia, vomiting, nausea, hypomagnesemia, abdominal pain, constipation, and hypophosphatemia. Please see the full Prescribing Information for REZZAYO (rezafungin for injection), available at . About Melinta Therapeutics, LLC Melinta Therapeutics is a biopharmaceutical company dedicated to providing innovative therapies to people impacted by acute and life-threatening illnesses. We focus our expanding portfolio on serving patients with an unmet need because that’s how we make the most meaningful impact. At Melinta, we’re visionaries dedicated to innovation while staying grounded in what matters most: patients. Our portfolio currently includes seven commercial-stage products: BAXDELA® (delafloxacin), KIMYRSA® (oritavancin), MINOCIN® (minocycline) for Injection, ORBACTIV® (oritavancin), REZZAYO® (rezafungin for injection), TOPROL-XL® (metoprolol succinate) and VABOMERE® (meropenem and vaborbactam). For more information about Melinta Therapeutics, our commitment to patients, and to learn about our portfolio of therapies, visit .

In vivo data demonstrated efficacy of SCY-247 in mouse model of invasive candidiasis caused by Candida glabrataSCY-247 showed in vitro activity against a broad range of pathogenic fungi, including azole-resistant strains of Candida and Aspergillus species JERSEY CITY, N.J., April 30, 2024 (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 the presentation of preclinical efficacy data on its second generation fungerp candidate SCY-247 at the ESCMID Global 2024 congress (formerly known as ECCMID) in Barcelona, Spain from April 27-30, 2024. "We continue to be excited about the potential of our second generation fungerp SCY-247 to address the critical need for new antifungal treatments, particularly for invasive fungal infections where current options are limited and resistance is increasing," said David Angulo, M.D., President and Chief Executive Officer of SCYNEXIS. "The positive data presented at ESCMID Global further strengthen our confidence in SCY-247's ability to combat these difficult-to-treat infections, and we look forward to its continued advancement as we aim to enter clinical stage by year end." Nathan Wiederhold, Pharm.D., Professor, Director – Fungus Testing Laboratory, University of Texas Health Science Center, San Antonio, delivered an oral presentation entitled, “The novel second-generation IV/oral triterpenoid SCY-247 is efficacious in an experimental murine model of invasive candidiasis caused by Candida glabrata.” C. glabrata, a high priority fungal pathogen on the World Health Organization fungal priority pathogens list (WHO FPPL), is a major cause of invasive candidiasis with an increasing rate of resistance against current antifungals. In a mouse model of invasive candidiasis caused by C. glabrata, SCY-247 showed promising in vivo efficacy. Following inoculation with C. glabrata, mice were treated with either vehicle control, oral SCY-247 (16, 32, & 48 mg/kg), oral fluconazole 20 mg/kg, or parenteral caspofungin 1 mg/kg for 7 days. In mice treated with SCY-247, dose-dependent reductions of fungal burden in both kidneys and lungs were observed. Fungal burden within the kidneys was significantly lower in each SCY-247 group versus vehicle (p0.01 for all comparisons). Lung fungal burden in the SCY-247 32 mg/kg and 48 mg/kg groups was also significantly lower versus placebo (p0.01 for both comparisons). In contrast, caspofungin significantly lowered fungal burden within the kidneys (p=0.01) but not the lungs, while fungal burden in mice treated with fluconazole was similar to controls in both organs. The findings in this model illustrate the meaningful efficacy of SCY-247 against C. glabrata, its ability to reach efficacious concentrations after oral administration and suggests an improved lung penetration of SCY-247 relative to echinocandins. Dr. Wiederhold also presented a poster entitled, “SCY-247, a novel second-generation IV/oral triterpenoid antifungal, demonstrates in vitro activity against fungal pathogens, including azole-resistant strains of Candida and Aspergillus.” In this study, SCY-247 was tested against 155 clinical isolates of yeasts, molds and dimorphic fungi. SCY-247 demonstrated in vitro activity against a broad range of pathogenic fungi, with the most potent activity observed against Candida species including C. albicans, C. auris, and C. glabrata as well as fluconazole-resistant strains. Potent activity was also observed against Aspergillus species, including voriconazole-resistant isolates, and against the dimorphic fungi Blastomyces dermatitidis, Histoplasma capsulatum, and Coccidioides species. Both studies presented by Dr. Wiederhold have been funded in whole or in part with Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under contract nos. HHSN272201700039 and 75N93019D00022. A second poster entitled, “Effect of SCY-247, a second-generation triterpenoid antifungal, on growth kinetics and ultrastructure of Candida auris,” was presented by Mahmoud Ghannoum, Ph.D., Professor, Case Western Reserve and Director, Center for Medical Mycology, University Hospitals Cleveland Medical Center. In this study, the antifungal effect of SCY-247 on cell morphology of both susceptible and multi-drug resistant C. auris was evaluated using Scanning Electron Microscopy (SEM) imaging. Results demonstrated that SCY-247 significantly inhibited the growth of both C. auris strains. Importantly, SCY-247 had a prominent effect on fungal cell morphology and significantly reduced fungal growth. About Invasive Fungal Infections Candida auris, a critical priority fungal pathogen in WHO fungal priority pathogens list (WHO FPPL), is an emerging fungal pathogen associated with nosocomial infections and considered a serious global health threat. It is often resistant to commonly used antifungal drugs, with about 90% of U.S. C. auris samples resistant to fluconazole and some C. auris strains resistant to all three main classes of antifungals (azoles, echinocandins and polyenes). Candida glabrata is the most common non-albicans species causing systemic fungal infections. It also has high levels of resistance to fluconazole, and echinocandin resistance appears to be increasing. Patients with Candida infections that are resistant to both fluconazole and echinocandin drugs have very few treatment options. Azole-resistant Aspergillus infections are also difficult to treat, and affected patients are up to 33% more likely to die than patients with infections that can be treated with azoles. About SCY-247 SCY-247 is a second-generation antifungal compound, from a novel class of structurally-distinct glucan synthase inhibitors, triterpenoids (fungerps), being developed to address systemic fungal diseases. The triterpenoid class of antifungals represents the first new class of antifungal compounds since 2001. These agents combine the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and intravenous (IV) formulations. SCY-247 is in pre-IND development stage and has demonstrated in vitro and in vivo broad-spectrum antifungal activity, including in MDR isolates (or spp.). SCYNEXIS anticipates that the U.S. Food and Drug Administration (FDA) may grant SCY-247 Qualified Infectious Disease Product (QIDP) and Fast Track designations for the IV and oral formulations of SCY-247. About SCYNEXIS SCYNEXIS, Inc. (NASDAQ: SCYX) is a biotechnology company pioneering innovative medicines to help millions of patients worldwide overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant. SCYNEXIS is developing the company’s proprietary antifungal platform “fungerps”. Ibrexafungerp, the first representative of this novel class, has been licensed to GSK. The U.S. Food and Drug Administration (FDA) approved BREXAFEMME® (ibrexafungerp tablets) in June 2021, for its first indication in vulvovaginal candidiasis (VVC), followed by a second indication in November 2022, for reduction in the incidence of recurrent VVC. Late-stage clinical investigation of ibrexafungerp for the treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing. Additional antifungal assets from this novel class are currently in pre-clinical and discovery phase, including the compound SCY-247. For more information, visit www.scynexis.com. Forward-Looking Statements 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, including but not limited to statements regarding: SCYNEXIS’s plans to begin a clinical study in SCY-247 by year end, confidence in SCY-247's ability to combat difficult-to-treat fungal infections, and SCY-247’s potential to be differentiated from currently available antifungals. 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 regulatory and other costs in developing products. These and other risks are described more fully in SCYNEXIS' filings with the Securities and Exchange Commission, including without limitation, its most recent Annual Report on Form 10-K filed on March 28, 2024, including under the caption "Risk Factors." 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 RelationsIrina KofflerLifeSci AdvisorsTel: (646) 970-4681ikoffler@lifesciadvisors.com