Melinta Therapeutics Announces Publication of the Outcomes by Candida Species from the ReSTORE Phase 3 trial and Recently Approved Rezafungin CLSI Breakpoints for Candida glabrata and Candida auris

PARSIPPANY, N.J.--(BUSINESS WIRE)-- Melinta Therapeutics, LLC today announced the peer-reviewed publication of data from the completed ReSTORE phase 3 global clinical trial evaluating REZZAYO^® (rezafungin for injection) for the treatment of candidemia and invasive candidiasis (IC) in adults. The data analyses in the article, “Outcomes by Candida spp. in the ReSTORE Phase 3 trial of rezafungin versus caspofungin for candidemia and/or invasive candidiasis,” published in the American Society for Microbiology Antimicrobial Agents and Chemotherapy, demonstrates the efficacy of rezafungin in adult patients across a variety of Candida species. Rates of global cure and mycological eradication at day 14 and all-cause mortality at day 30 were generally comparable between the two treatment groups.

The article additionally highlights the approval of the Clinical and Laboratory Standards Institute (CLSI) susceptibility breakpoints for rezafungin against several Candida species including Candida glabrata, a species increasingly associated with reduced susceptibility to treatment with echinocandins, and Candida auris, a highly resistant pathogen that is associated with life-threating infections. Rezafungin is the only antifungal, based on in vitro data, that has a defined susceptibility breakpoint for C. auris approved by CLSI; the efficacy of rezafungin in treating candidemia or invasive candidiasis caused by this pathogen has not been established in adequate and well-controlled clinical trials.

Christine Ann Miller, president and chief executive officer of Melinta Therapeutics, said, “We are delighted with the release of this analysis of data from the ReSTORE Phase 3 trial, which supports the effectiveness and safety of REZZAYO in comparison to caspofungin and are also pleased to see that CLSI approved the REZZAYO susceptibility breakpoints for Candida pathogens, including C. auris, which has been identified as a potential global threat by the CDC and WHO.”

She added, “Melinta has been leveraging our expertise in hospital and acute care environments to commercialize REZZAYO, making it available to healthcare providers and their patients affected by candidemia and invasive candidiasis. This effort supports our mission to provide innovative therapies to people impacted by acute and life-threatening illnesses.”

Melinta holds the exclusive rights to commercialize rezafungin in the U.S. from Mundipharma.

About REZZAYO^® (rezafungin for injection)

REZZAYO (rezafungin for injection) is a novel once weekly echinocandin approved in the United States for the treatment of candidemia and invasive candidiasis in adults. REZZAYO is currently being studied for the prevention of invasive fungal diseases in adults undergoing allogeneic blood and marrow transplantation.

INDICATIONS AND USE

REZZAYO is an echinocandin antifungal indicated in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis. Approval of this indication is based on limited clinical safety and efficacy data.

REZZAYO has not been studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida.

IMPORTANT SAFETY INFORMATION

Contraindications

REZZAYO is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins.

Warnings and Precautions

• Infusion-related Reactions: REZZAYO may cause infusion-related reactions, including flushing, sensation of warmth, urticaria, nausea, or chest tightness. If these reactions occur, slow or pause the infusion.
• Photosensitivity: REZZAYO may cause photosensitivity. Advise patients to use protection from sun exposure and other sources of UV radiation.
• Hepatic Adverse Reactions: Abnormalities in liver tests have been seen in clinical trial patients treated with REZZAYO. Monitor patients who develop abnormal liver tests and evaluate patients for their risk/benefit of continuing REZZAYO therapy.

Adverse Reactions

Most common adverse reactions (incidence ≥ 5%) are hypokalemia, pyrexia, diarrhea, anemia, vomiting, nausea, hypomagnesemia, abdominal pain, constipation, and hypophosphatemia.

Please see the full Prescribing Information for REZZAYO (rezafungin for injection), available at www.rezzayo.com.

About Melinta Therapeutics, LLC

Melinta Therapeutics is a biopharmaceutical company dedicated to providing innovative therapies to people impacted by acute and life-threatening illnesses. We focus our expanding portfolio on serving patients with an unmet need because that’s how we make the most meaningful impact. At Melinta, we’re visionaries dedicated to innovation while staying grounded in what matters most: patients. Our portfolio currently includes seven commercial-stage products: BAXDELA^® (delafloxacin), KIMYRSA^® (oritavancin), MINOCIN^® (minocycline) for Injection, ORBACTIV^® (oritavancin), REZZAYO^® (rezafungin for injection), TOPROL-XL^® (metoprolol succinate) and VABOMERE^® (meropenem and vaborbactam). For more information about Melinta Therapeutics, our commitment to patients, and to learn about our portfolio of therapies, visit www.melinta.com.

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