Cidara Therapeutics and Mundipharma receive positive CHMP opinion for rezafungin for the treatment of Invasive Candidiasis in adults(1)

• The opinion was based on positive results from the pivotal ReSTORE Phase III clinical trial and supported by the STRIVE Phase II clinical trials and extensive nonclinical development program.^2,3
• If approved by the European Medicines Agency, rezafungin could be the first new treatment option in over 10 years for patients with invasive candidiasis.⁴

SAN DIEGO and CAMBRIDGE, England, Oct. 13, 2023 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, and Mundipharma today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for rezafungin (rezafungin acetate) for the treatment of invasive candidiasis in adults.¹

The CHMP based its positive opinion on results from the pivotal ReSTORE Phase III clinical trial, which demonstrated statistical non-inferiority* for rezafungin, dosed once weekly, when compared to the current standard of care, caspofungin, dosed once daily. This finding was supported by the STRIVE Phase II clinical trials and extensive nonclinical development program.^2,3 The ReSTORE trial provides evidence of the efficacy and safety of rezafungin as a potential new treatment option for invasive candidiasis with a once-weekly dosing schedule.²

Invasive candidiasis, is a severe, life-threatening infection of the bloodstream and/or deep/visceral tissues.^5,6 It affects seriously ill people, especially those with a weakened immune system where the mortality rate can be 40% or more.^7,8 There is a clear need for alternative options to treat this disease, particularly as there have been no new treatment options over the last decade.^4,9

Professor Oliver Cornely, Head of the European Excellence Centre for Medical Mycology at the University Hospital Cologne, Germany, and Data Review Committee member in the Phase III ReSTORE trial, said, “This positive opinion is welcome news for patients who suffer from invasive candidiasis in the European Union where the mortality rate for patients with invasive candidiasis remains high. A new treatment option for these serious infections is a much-needed addition.”