The FDA announced the approval of Melinta Therapeutics’s and Cidara Therapeutics’s Rezzayo (rezafungin acetate) in March 2023, the first drug to be marketed for the treatment of candidemia and invasive candidiasis in over a decade. Following this approval, the companies have recently announced the publication of pooled data from two completed global clinical trials. The results further validate the efficacy and safety of Rezzayo, a novel once-weekly echinocandin antifungal indicated for adults with limited or no alternative options for the treatment of candidemia and candidiasis.
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, an echinocandin administered once daily by intravenous (IV) infusion, for all-cause mortality, and provided safety and supportive efficacy data. In both studies, researchers evaluated one 400mg dose of Rezzayo for the first week followed by 200mg Rezzayo dosed once weekly, for up to four weeks in total. Rezzayo was generally well tolerated and had a similar safety profile to caspofungin. The clinical success of Rezzayo is a positive step forward in the treatment of candidemia and invasive candidiasis.
Invasive candidiasis is a collective term that refers to a group of infectious conditions caused by a variety of Candida species. Candidemia is probably the most commonly recognised infection, which results when Candida enters the bloodstream and infects internal organs, including, but not limited to, the eyes, heart, brain, and kidneys. Candidemia and invasive candidiasis are common healthcare-related conditions and are major causes of morbidity and mortality. Their incidences are increasing worldwide due to the growing population of immunocompromised individuals and those receiving invasive medical procedures, as these people are more susceptible to such infections. Symptoms can be difficult to detect as most people who develop these conditions are already sick or recovering from surgery, and the signs are similar to other common infections, including fever, pain, and weakness, amongst others. Current treatment options are limited to only three antifungal classes: echinocandins, polyenes, and azoles, with the latter being the only class available in oral form. In addition to this, most therapies have become increasingly ineffective due to a rise in drug-resistant strains. It is therefore important that these conditions are treated promptly and correctly to save lives. Hence, Rezzayo addresses an unmet need for the treatment of candidemia and invasive candidiasis, providing a new option to treat these deadly fungal infections.
There are various other antifungals in development for the treatment of candidemia and invasive candidiasis. One of the most developmentally advanced of these is Scynexis’s ibrexafungerp citrate, a small molecule antifungal currently in Phase III development. This therapy is already marketed for vulvovaginal candidiasis in the US under the brand name Brexafemme. It has also shown promising clinical trial results for the treatment of candidemia and invasive candidiasis. 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% of patients receiving ibrexafungerp citrate showed a complete or partial response, while 11% had stable disease. It is hoped that there will be continued progress in the candidemia and invasive candidiasis treatment market space 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.
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