The European Commission (EC) has adopted the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) recommendation to grant Orphan Drug Designation (ODD) to Mundipharma and Cidara Therapeutics’ rezafungin for treating invasive candidiasis (IC).
IC is a severe, life-threatening Candida infection of the bloodstream and / or deep / visceral tissues.
A novel, once weekly echinocandin, rezafungin is currently in Phase III trials for treating severe fungal infections.
Mundipharma holds exclusive rights to develop and market the drug in all markets except the US and Japan, where Cidara retains the rights.
Mundipharma chief scientific officer Brian Sheehan said: “Orphan drug designation is an important milestone in the development of rezafungin, which is currently in Phase III clinical trials.
“Fungal infections still pose a major threat to the lives of hospitalised or immunocompromised patients. We are proud that patients affected with invasive candidiasis may have an additional treatment option to treat this potentially life-threatening condition.”
The latest development comes after rezafungin was granted the US Food and Drug Administration’s (FDA) Qualified Infectious Disease Product (QIDP) with Fast Track status and ODD for use in treating IC, including candidaemia.
Cidara Therapeutics president and CEO Jeffrey Stein said: “We are pleased by the decision of the EMA to grant orphan drug designation to rezafungin, further supporting its potential as the first new antifungal for the treatment of serious invasive Candida infections in nearly 15 years.”
Studies so far showed that rezafungin has a unique pharmacokinetic profile with an extended half-life and is dosed for front-loaded plasma exposure.
A pivotal Phase III ReSTORE study is analysing the safety, tolerability and efficacy of rezafungin versus caspofungin for treating candidemia and IC in 184 subjects.
Another study, Phase III ReSPECT trial, is evaluating rezafungin compared to the standard antimicrobial regimen to prevent invasive fungal disease due to Candida, Aspergillus and Pneumocystis in participants undergoing allogeneic blood and marrow transplantation.
In September 2019, Cidara partnered with Mundipharma in a deal valued at more than $568m to develop and commercialise its anti-fungal drug triafungin.