EMA starts review of Cidara's candidiasis therapy rezafungin


The EU regulator has started its review of Cidara Therapeutics' once-weekly antifungal rezafungin, setting up a decision next year as a new option for serious, invasive infections caused by candida species.

The filing is based on the ReSTORE trial of rezafungin, a drug in the echinocandin class, which met its objectives by showing that rezafungin was as effective as daily dosing with the decades-old drug caspofungin in severe candidemia and/or invasive candidiasis.

If approved, rezafungin could become the first new front-line therapy for severe candida infections in well over a decade, and provide a much-needed new option for patients who don’t respond to current front-line drugs.

Antifungal resistance is an increasing problem with candida species and an often under-recognized aspect of antimicrobial resistance (AMR), which is an emerging global crisis. A recent review in the journal Nature noted that AMR programmes have often excluded antifungals because fungi have been "widely neglected as a threat to public health."

The EU filing comes shortly after Cidara and US partner for the drug Melinta Therapeutics filed for FDA approval of rezafungin, with a decision there expected in the first quarter of 2023. Melinta paid Cidara $30 million upfront for US rights to the drug in a deal that could be worth up to $460 million plus royalties on sales.

Mundipharma has commercial rights to the antifungal drug in all markets outside the US and Japan under the terms of a 2019 deal that included an upfront fee of $30 million, an equity investment of $9 million and up to $529 million in milestone payments, plus royalties.

"Rezafungin, as a next generation echinocandin, represents the first advancement in the treatment of invasive candida infections in a very long time," said Brian Sheehan, Mundipharma's chief scientific officer.

"If approved, the treatment could bring new hope for critically ill, vulnerable patients battling with this deadly disease in the EU," he added.

Despite currently available treatments, the mortality rate for patients with invasive candidiasis remains high at up to 40%,.

That unmet need has led Cidara to predict a $400 million market opportunity for rezafungin, rising to $750 million if the drug also hits the mark in the ReSPECT trial, where it is being used to prevent infections with candida, aspergillus and pneumocystis species in blood and bone marrow transplant patients.

Image by GrahamColm via Wikimedia Commons