Melinta Therapeutics and Cidara Therapeutics released extensive data from two global clinical trials on their candidemia and invasive candidiasis drug Rezzayo (rezafungin acetate). The findings affirm the safety and efficacy of Rezzayo, a novel echinocandin antifungal administered through weekly intravenous (IV) infusion. This reinforces its market position, emphasizing its efficacy and safety in addressing fungal infections, says GlobalData, a leading data and analytics company.

Rezzayo became the first drug to be approved for the treatment of candidemia and invasive candidiasis in over 10 years following the FDA approval earlier this year.

Anaelle Tannen, Infectious Disease Analyst at GlobalData comments: “Rezzayo is indicated for adults with limited or no alternative options for the treatment of candidemia and invasive candidiasis. The drug showed clinical success, demonstrating non-inferiority to capsofungin, an echinocandin administered once daily by IV infusion. These findings are beneficial, especially in cases where other treatment options have failed due to limitations including toxicities, drug–drug interactions, daily IV administration and increasing antifungal resistance.”

The article, published in the Lancet Infectious Diseases, provides pooled data analyses from the pivotal ReSTORE Phase III trial and the STRIVE Phase II trial.  The data demonstrated non-inferiority of Rezzayo as compared to caspofungin, for all-cause mortality and provided safety and supportive efficacy data.

Tannen adds: “Rezzayo addresses an unmet need for the treatment of candidemia and invasive candidiasis. Providing a new option to treat these deadly fungal infections is needed at a time when antifungal resistance is on the rise. Rezzayo also has potential to ease the management of such diseases as it is a once-weekly injection.”

Candidemia and invasive candidiasis are major causes of morbidity and mortality, and their incidences are increasing worldwide. However, there are several other antifungals in development for the treatment of candidemia and invasive candidiasis. One of the most developmentally advanced of these is Scynexis’ Ibrexafungerp citrate. The drug is currently in Phase III development and has demonstrated promising results in clinical trials*.

Tannen concludes: “We will see continued progress in the candidemia and invasive candidiasis market with the eventual launch of more pipeline products. However, there is still a strong need for more antifungals, especially with the rise of antifungal resistance, and therefore there is room for more development and activity in this space.”

*Ibrexafungerp citrate is already marketed for vulvovaginal candidiasis in the US under the brand name Brexafemme. Interim results from a Phase III study assessing Ibrexafungerp citrate as a treatment for invasive candidiasis/candidemia due to Candida auris (C. auris) showed that 78% had a complete or partial response, whilst 11% had stable disease.