Melinta Reports ReSTORE Trial Outcomes and Rezafungin Breakpoints for Candida

Melinta Therapeutics, LLC recently announced the publication of data from the ReSTORE Phase 3 global clinical trial, which evaluated the effectiveness of REZZAYO® (rezafungin for injection) in treating candidemia and invasive candidiasis (IC) in adults. Published in the American Society for Microbiology's "Antimicrobial Agents and Chemotherapy," the article titled “Outcomes by Candida spp. in the ReSTORE Phase 3 trial of rezafungin versus caspofungin for candidemia and/or invasive candidiasis” reveals that rezafungin shows comparable efficacy to caspofungin in adult patients across various Candida species.

The trial's results indicate that rates of global cure and mycological eradication at day 14, as well as all-cause mortality at day 30, were generally similar between the two treatment groups. This substantiates the effectiveness of rezafungin for these conditions. Furthermore, the publication highlights that the Clinical and Laboratory Standards Institute (CLSI) has approved susceptibility breakpoints for rezafungin against several Candida species, including Candida glabrata and Candida auris. Notably, rezafungin is currently the only antifungal agent with a defined susceptibility breakpoint for C. auris approved by CLSI, although its effectiveness against this pathogen in clinical settings has not yet been established through well-controlled trials.

Christine Ann Miller, President and CEO of Melinta Therapeutics, expressed satisfaction with the trial's data publication, emphasizing that it supports the safety and efficacy of REZZAYO compared to caspofungin. She also noted the significance of the CLSI's approval of rezafungin's susceptibility breakpoints for Candida pathogens, particularly C. auris, which has been identified as a significant global threat by both the CDC and WHO.

Miller added that Melinta Therapeutics is utilizing its expertise in hospital and acute care environments to make REZZAYO accessible to healthcare providers and patients affected by candidemia and invasive candidiasis. This initiative aligns with the company's mission to offer innovative therapies to individuals with acute, life-threatening illnesses. Melinta holds the exclusive rights to commercialize rezafungin in the United States through an agreement with Mundipharma.

REZZAYO (rezafungin for injection) is a novel, once-weekly echinocandin approved in the U.S. for treating candidemia and invasive candidiasis in adults. It is currently undergoing further studies to evaluate its potential in preventing invasive fungal diseases in adults undergoing allogeneic blood and marrow transplantation.

REZZAYO is specifically indicated for patients aged 18 and older who have limited or no alternative treatment options for candidemia and invasive candidiasis. The approval of this indication is based on limited clinical safety and efficacy data. Importantly, REZZAYO has not been studied in patients with endocarditis, osteomyelitis, and meningitis caused by Candida.

It is crucial to consider the safety information associated with REZZAYO. The drug is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins. Additionally, potential adverse reactions include infusion-related reactions, photosensitivity, and hepatic adverse reactions. Common adverse reactions (incidence ≥ 5%) include hypokalemia, pyrexia, diarrhea, anemia, vomiting, nausea, hypomagnesemia, abdominal pain, constipation, and hypophosphatemia.

Melinta Therapeutics is dedicated to developing innovative therapies for acute and life-threatening illnesses. Their expanding portfolio aims to address unmet medical needs, thereby making a significant impact on patient care. Currently, Melinta's portfolio includes seven commercial-stage products, including BAXDELA®, KIMYRSA®, MINOCIN® for Injection, ORBACTIV®, REZZAYO®, TOPROL-XL®, and VABOMERE®.