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IV"},{"orgOrder":0,"company":"Mundipharma","sponsor":"Cidara Therapeutics","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Cidara Therapeutics Announces Divestiture of Rezafungin to Mundipharma* to Focus on Advancing the Clinical Development of Cloudbreak DFC Pipeline","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase IV","country":"GERMANY","productType":"Small molecule","productStatus":"Approved","date":"April 2024","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase IV"}]
Find Clinical Drug Pipeline Developments & Deals by Mundipharma
Through the divestment, Mundipharma received the rights for Rezzayo (rezafungin acetate), an echinocandin antifungal, approved for the treatment of invasive candidiasis in adults.
The two companies have entered into a collaboration agreement to continue the development work of incorporating an environmentally friendly propellant into the formulation of flutiform® (fluticasone propionate/formoterol fumarate) used in a pMDI.
The payment triggered under the agreement is following the European approval of Rezzayo (rezafungin acetate), a novel, once-weekly echinocandin antifungal approved for the treatment of invasive candidiasis in adults.
Rezzayo (rezafungin) 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.
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.
CD101 (rezafungin) is a novel, once-weekly echinocandin being developed for both the treatment and prevention of serious fungal infections,demonstrated non-inferiority to the current standard of care in the treatment of candidemia and/or invasive candidiasis.
Rezafungin is a novel once-weekly echinocandin being developed for both the treatment and prevention of serious fungal infections, such as candidemia and invasive candidiasis.
European Medicines Agency filing is supported by the pivotal ReSTORE Phase III clinical trial results, where rezafungin (echinocandin/CD101) demonstrated non-inferiority to the current standard of care, caspofungin in the treatment of candidemia and/or invasive candidiasis.
Results from ReSTORE showed primary endpoints were met with, 23.7% all-cause mortality on day 30 for rezafungin compared to 21.3% for caspofungin global cure on day 14 of 59.1% for rezafungin and 60.6% for caspofungin.
Result, did not demonstrate highly potent antifungal properties of CD101 against Candida in preclinical animal models of VVC, CD101 IV has enhanced potency and is only once-weekly therapy intended for treatment and prevention of life-threatening invasive fungal infections.
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