Candidiasis, Chronic Mucocutaneous

CAMBRIDGE, England--( BUSINESS WIRE )--Napp today announces that the MHRA has accepted a marketing authorisation application for rezafungin, a novel echinocandin in clinical development for the treatment of invasive candidiasis in adult patients. The marketing authorisation application is based on results from the pivotal ReSTORE Phase III clinical trial, which demonstrated statistical non-inferiority of rezafungin dosed once-weekly when compared to the current standard of care, caspofungin, dosed once daily. This trial provides evidence of efficacy and the safety profile of rezafungin as a potential treatment for candidemia and invasive candidiasis with a once-weekly dosing schedule. 1 Invasive candidiasis is a severe, life-threatening systemic Candida infection of the bloodstream and/or deep/visceral tissues. 2 Despite current treatments, the mortality rate for patients with invasive candidiasis remains high at up to 40%. 3 Antifungal drug resistance is becoming an increasing concern, with 90% of Candida auris strains showing resistance to fluconazole, one of the major treatment options. Echinocandin resistance is currently uncommon (5–10%). 4 There is a real need for new treatment options to address this serious disease, especially as there has been no significant additional treatment options over the last decade. In the ReSTORE trial, rezafungin met the primary endpoint for the European Medicines Agency (EMA) marketing authorisation application of global cure at Day 14. The MHRA has agreed they will accept the EMA primary endpoint. “ If approved, rezafungin, as a novel, once-weekly echinocandin, could bring new hope for critically ill, vulnerable patients battling with this difficult-to-treat and often deadly disease,“ said Brian Sheehan, Ph.D., Chief Scientific Officer at Mundipharma. “With the rise in multidrug-resistant Candida strains in hospitals, this MHRA marketing authorisation submission is a positive step, and we hope we will be able to work with the MHRA to bring this medicine to patients who need it.” Rezafungin has already been granted Orphan Drug Designation for its use in the treatment of invasive candidiasis in both the EU and US.5 ,6 It has been identified as a Qualified Infectious Disease Product (QIDP) by the US Food and Drug Administration (FDA), 7 which confers both Fast Track and Priority Review status and has been accepted for marketing authorisation review by the EMA. In the US, the FDA has granted Priority Review to Cidara Therapeutics New Drug Application for rezafungin for the treatment of candidemia and invasive candidiasis. 8 Cidara Therapeutics has partnered with Mundipharma, which has commercial rights to rezafungin outside the US and Japan. About Invasive Candidiasis Invasive candidiasis (IC) continues to be an area of significant unmet need, especially for critically ill patients in hospitals and patients with compromised immune systems. Despite a number of available treatments, the mortality rate for patients with invasive candidiasis is as high as 40%. 3 IC is characterised as a severe, life-threatening systemic Candida infection of the bloodstream and/or deep/visceral tissues, known as candidemia and deep-seated tissue candidiasis. 2 About Rezafungin Rezafungin is a novel, once-weekly echinocandin being developed for both the treatment and prevention of serious fungal infections, such as invasive candidiasis and candidemia. The structure and properties of rezafungin are specifically designed to improve upon a clinically validated mechanism intended to enhance its efficacy and safety potential for patients. Cidara has completed a Phase III clinical trial with rezafungin for the treatment of candidemia and/or invasive candidiasis (ReSTORE trial).9 In this ReSTORE trial, rezafungin met the primary endpoint for the European Medicines Agency (EMA) Marketing Authorization Application (MAA) submission of global cure at Day 14, which the MHRA has agreed to accept, and also met the primary endpoint for the U.S. Food and Drug Administration (FDA) New Drug Application (NDA) submission of all-cause mortality at Day 30. Both of these results demonstrated statistical non-inferiority of rezafungin dosed once-weekly, versus caspofungin dosed once-daily, which is the current standard of care. Rezafungin was generally well tolerated and had a similar safety profile to caspofungin. 9 Cidara is also currently conducting a second Phase III clinical trial of rezafungin for the prevention of invasive fungal disease in patients undergoing allogeneic blood and marrow transplantation (ReSPECT trial). About Napp Napp is part of the global network of Mundipharma independent associated companies, which has a presence across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East. Mundipharma is dedicated to bringing innovative treatments to patients in the areas of Pain Management, Infectious Disease and Consumer Healthcare as well as other severe and debilitating disease areas. Our guiding principles, centered around Integrity and Patient-Centricity, are at the heart of everything we do. For more information visit www.mundipharma.com . Registered office addresses NAPP PHARMACEUTICALS LIMITED a company having its registered office at Cambridge Science Park, Milton Road, Cambridge CB4 0AB, England. MUNDIPHARMA RESEARCH LIMITED, a company having its registered office at Cambridge Science Park, Milton Road, Cambridge, CB4 OAB, England. References 1 Thompson, G.R. et al, ReSTORE: Efficacy and Safety Results of the Phase 3, Noninferiority Trial of Rezafungin in the Treatment of Candidemia and/or Invasive Candidiasis, Abstract presented at ECCMID 2022 2 Cortes JA, Corrales IF. Invasive Candidiasis: Epidemiology and Risk Factors. November 2018. Available at https://www.intechopen.com/chapters/64365. Last accessed October 2022. 3 Kullberg BJ, Arendrup MC. Invasive Candidiasis. N Engl J Med 2015;373:1445-1456. 4 Cortegiani A et al. Crit Care. 2019;23(1):150. 5 U.S. Food & Drug Administration. Search Orphan Drug Designations and Approvals. Available at: https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=%20507215 . Last accessed October 2022. 6 European Commission. Community Register of orphan medicinal products. Available at: https://ec.europa.eu/health/documents/community-register/html/o2385.htm . Last accessed October 2022. 7 U.S. Food & Drug Administration. Search Orphan Drug Designations and Approvals. Available at: https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey= 507215 . Last accessed October 2022. 8 Cidara Therapeutics Press Releases. Available at: https://www.cidara.com/news/cidara-therapeutics-announces-fda-acceptance-for-priority-review-of-new-drug-application-for-rezafungin-for-the-treatment-of-candidemia-and-invasive-candidiasis/ . Last accessed October 2022. 9 Cidara Therapeutics and Mundipharma Announce Positive Topline Results from the Global Phase 3 Pivotal ReSTORE Trial of Rezafungin for the Treatment of Candidemia and Invasive Candidiasis. Available at: https://www.mundipharma.com/Mundipharma-and-Cidara-Therapeutics-Announce-First-Presentation-of-Results-from-Global-Phase-3-ReSTORE-Trial-of-Rezafungin-for-Treatment-of-Candidemia-and/or-Invasive-Candidiasis-Demonstrating-its-Positive-Efficacy-and-Safety-Profile .Last accessed October 2022. Job code: UK-RZF-2200009 Date of preparation: November 2022

JERSEY CITY, N.J., Oct. 24, 2022 (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 cumulative interim outcomes and all-cause mortality data in patients with refractory candidiasis treated with oral ibrexafungerp from the ongoing Phase 3 FURI study. The analyses were presented during IDWeek 2022 held in Washington, D.C., October 19-23, 2022. “We are pleased to present these aggregate data from previous interim analysis showing favorable outcomes in our ongoing FURI trial, which focuses on the potential of ibrexafungerp to help patients with challenging fungal infections,” said David Angulo, M.D., Chief Medical Officer of SCYNEXIS. “These results reinforce our conviction that ibrexafungerp has the potential to benefit patients with severe fungal disease and limited treatment options, and they are supportive of our plans to pursue a salvage therapy indication for ibrexafungerp.” FURI Outcomes by Fungal Disease Type Ibrexafungerp demonstrated a favorable therapeutic response for the majority of patients with a variety of serious fungal infections who have failed or are intolerant to currently available treatments or for whom currently available oral antifungals are not adequate due to resistance and IV therapy is no longer feasible or desirable. The data presented includes 113 patients enrolled in the FURI study who had completed treatment through October 2021. Of these patients, the most common fungal disease was invasive candidiasis/candidemia (IC) in 56 (49.6%), followed by severe mucocutaneous candidiasis in 32 (28.3%), refractory vulvovaginal candidiasis (VVC) in 14 (12.3%), and invasive aspergillosis (IA) in 11 (9.7%). Complete or partial response was reported in 62.5% of patients with IC with an additional 23.2% reporting stable disease. For patients with severe mucocutaneous candidiasis, 53.1% reported complete or partial response and 34.4% reported stable disease. Most subjects with refractory VVC also responded favorably, with 71.4% achieving clinical improvement. Six of 11 patients with invasive aspergillosis achieved complete/partial response or stable disease. All-Cause Mortality in Patients with Invasive Candidiasis All-cause mortality outcomes through 30 days post completion of ibrexafungerp treatment was presented as a poster. Fifty-six of 113 FURI patients (49.6%) in this data set had a diagnosis of invasive candidiasis (41/56; 73.2%) or candidemia (15/56; 26.8%). In this population with difficult to treat fungal infections with limited treatment options, the most common pathogens were Candida glabrata, C. albicans, C. krusei and other non-albicansCandida species. Overall survival at Day 30 was 94.6% (3 deaths out of 56 patients). Ibrexafungerp Pipeline Update In addition, Nkechi Azie, M.D., Vice President, Clinical Development and Medical Affairs at SCYNEXIS, presented an ibrexafungerp pipeline update during the New Antimicrobials and ID Diagnostics in the Pipeline – Fungal session at the conference. “We are pleased to have had the opportunity to present an overview of our ibrexafungerp program and ongoing trials,” Dr. Azie said. “We are proud of our continued clinical progress as we remain committed to bringing our innovative, potent antifungal to market as a potential option for patients with difficult to treat fungal infections.” About Ibrexafungerp Ibrexafungerp [pronounced eye-BREX-ah-FUN-jerp] is an antifungal agent and the first representative of a novel class of structurally-distinct glucan synthase inhibitors, triterpenoids. This agent combines the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and intravenous (IV) formulations. Ibrexafungerp is in late-stage investigation and development for multiple indications, including life-threatening fungal infections caused primarily by Candida (including C. auris) and Aspergillus species in hospitalized patients. It has demonstrated broad-spectrum antifungal activity, in vitro and in vivo, against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains. The FDA granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for the oral and IV formulations of ibrexafungerp for the indications of invasive candidiasis (IC), including candidemia, and invasive aspergillosis (IA) and has granted Orphan Drug Designation for the IC and IA indications. The European Medicines Agency (EMA) has granted ibrexafungerp Orphan Medicinal Product designation for the indication of IC. Ibrexafungerp is formerly known as SCY-078. INDICATION BREXAFEMME is a triterpenoid antifungal indicated for the treatment of adult and postmenarchal pediatric females with vulvovaginal candidiasis (VVC). DOSAGE AND ADMINISTRATION The recommended dosage of BREXAFEMME is 300 mg (two tablets of 150 mg) twice a day for one day, for a total treatment dosage of 600 mg. BREXAFEMME may be taken with or without food. IMPORTANT SAFETY INFORMATION BREXAFEMME is contraindicated during pregnancy and in patients with a history of hypersensitivity to ibrexafungerp BREXAFEMME administration during pregnancy may cause fetal harm based on animal studies. Prior to initiating treatment, verify pregnancy status in females of reproductive potential and advise them to use effective contraception during treatment When administering BREXAFEMME with strong CYP3A inhibitors, the dose of BREXAFEMME should be reduced to 150 mg twice a day for one day. Administration of BREXAFEMME with strong CYP3A inducers should be avoided Most common adverse reactions observed in clinical trials (incidence ≥2%) were diarrhea, nausea, abdominal pain, dizziness, and vomiting To report SUSPECTED ADVERSE REACTIONS, contact SCYNEXIS, Inc. at 1-888-982-SCYX (1-888-982-7299) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For more information, visit . Please click here for Prescribing Information. 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 scientists are developing the company’s lead asset, ibrexafungerp (formerly known as SCY-078), as a broad-spectrum, systemic antifungal for multiple fungal indications in both the community and hospital settings. SCYNEXIS has initiated the launch of its first commercial product in the U.S., BREXAFEMME® (ibrexafungerp tablets). The U.S. Food and Drug Administration (FDA) approved BREXAFEMME on June 1, 2021. SCYNEXIS filed a supplemental New Drug Application (sNDA) to expand BREXAFEMME’s labelling to include the prevention of recurrent vulvovaginal candidiasis, and the FDA assigned a target PDUFA action date of November 30, 2022, for this additional indication. In addition, late-stage clinical investigation of oral ibrexafungerp for the treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing. For more information, visit www.scynexis.com.

JERSEY CITY, N.J., Sept. 01, 2022 (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 it will present posters at four upcoming U.S. and international medical conferences in September. United States Mycoses Study Group Education and Research Consortium (MSGERC) Biennial Meeting – September 7-9, 2022, Albuquerque, N.M. Title: Outcomes of Oral Ibrexafungerp in Refractory Patients with Candida Infections from an Open-Label Study in Patients with Serious Fungal Infections (FURI) Date: Friday, September 9 Time: 3:30 pm – 5:00 pm MDT Presenter: Nkechi Azie, M.D. Title: Outcomes of Oral Ibrexafungerp in the Treatment of 10 Patients with Candida auris Infections, from the CARES Study Date: Friday, September 9 Time: 3:30 pm – 5:00 pm MDT Presenter: Nkechi Azie, M.D. World Anti-Microbial Resistance (AMR) Congress – September 7-9, 2022, National Harbor, Md. Title: Ibrexafungerp, a Novel Triterpenoid Antifungal in Development for the Treatment of CDC Urgent Threat Pathogen, Candida auris Date: Wednesday, September 7, and Thursday, September 8 Time: 10:20 am EDT both days Presenter: Thomas King, MS, MPH International International Immunocompromised Host Society (ICHS) – September 8-11, 2022, Basel, Switzerland Title: Oral Ibrexafungerp Outcomes in Patients with Chronic Mucocutaneous Candidiasis (CMC) Date: Saturday, September 10 Time: 10:00 am -10:30 am CEST Presenters: Riina Rautemma-Richardson and Chris Eades, Manchester University 21st Congress of the International Society for Human and Animal Mycology (ISHAM) –September 20-24, 2022, New Delhi, India Title: All-Cause Mortality in Patients with Invasive Candidiasis or Candidemia from an Interim Analysis of a Phase 3 Open-label Study (FURI) Date: Wednesday, September 21 Time: 12:30 pm - 1:30 pm IST Presenter: Juergen Prattes, M.D., Medical University of Graz Title: Oral Ibrexafungerp Outcomes by Fungal Disease in Patients from an Interim Analysis of a Phase 3 Open-label Study (FURI) Date: Wednesday, September 21 Time: 12:30 pm - 1:30 pm IST Presenter: Juergen Prattes, M.D., Medical University of Graz 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 scientists are developing the company’s lead asset, ibrexafungerp (formerly known as SCY-078), as a broad-spectrum, systemic antifungal for multiple fungal indications in both the community and hospital settings. SCYNEXIS has initiated the launch of its first commercial product in the U.S., BREXAFEMME® (ibrexafungerp tablets). The U.S. Food and Drug Administration (FDA) approved BREXAFEMME on June 1, 2021. The FDA has accepted the Company’s sNDA submission for prevention of recurrent vulvovaginal candidiasis (RVVC) and assigned a PDUFA decision date of November 30, 2022. In addition, late-stage clinical investigation of oral ibrexafungerp for the treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing. For more information, visit . CONTACT: Investors Irina Koffler LifeSci Advisors, LLC ikoffler@lifesciadvisors.com Media Debbie Etchison SCYNEXIS debbie.etchison@scynexis.com