Cidara Therapeutics and Melinta Therapeutics Announce Publication of Data from the Global Phase 3 Pivotal ReSTORE Trial of Rezafungin for the Treatment of Candidemia and Invasive Candidiasis in The Lancet
Cidara Therapeutics, Inc. (NASDAQ: CDTX) and Melinta Therapeutics announced the peer-reviewed publication of pivotal Phase 3 trial data for rezafungin, a novel once-weekly antifungal. The study, published in The Lancet, shows that rezafungin is statistically noninferior to the daily caspofungin for treating candidemia and invasive candidiasis. The FDA has granted Priority Review for rezafungin's NDA, with a target action date set for March 22, 2023. The data highlight rezafungin's potential to transform treatment for serious fungal infections, following positive topline results reported in December 2021.
- Rezafungin demonstrated statistical noninferiority to caspofungin in the Phase 3 ReSTORE trial.
- FDA granted Priority Review for the NDA with a target action date of March 22, 2023.
- Positive Phase 3 results from ReSTORE trial support rezafungin as a new treatment for serious fungal infections.
- Risk of FDA rejection or delays in the NDA approval process could impact market entry.
- Potential for clinical trial delays or adverse results in ongoing studies could affect future development.
Publication details the efficacy and safety of rezafungin dosed once-weekly versus the current of care dosed once-daily
Rezafungin PDUFA target action date is scheduled for March 22, 2023
SAN DIEGO and PARSIPPANY, N.J., Nov. 28, 2022 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ: CDTX) and Melinta Therapeutics, LLC today announced the peer-reviewed publication of data from the completed pivotal ReSTORE Phase 3 clinical trial evaluating the efficacy and safety of its once-weekly antifungal candidate rezafungin as a potential treatment for candidemia and invasive candidiasis. The data, published in The Lancet titled, “Rezafungin versus caspofungin for treatment of candidaemia and invasive candidiasis (ReSTORE): a multicentre, double-blind, double-dummy, randomised phase 3 trial,” demonstrate the statistical noninferiority of rezafungin dosed once-weekly, versus the current standard of care caspofungin, dosed once-daily.
“We are proud to have our Phase 3 clinical data published in one of world's highest-impact academic medical journals, The Lancet, providing detailed results to the scientific and physician communities and showcasing the efficacy and safety of rezafungin,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “These data demonstrate that rezafungin dosed once-weekly was noninferior to caspofungin dosed once-daily, an important achievement that has the potential to transform the treatment landscape for invasive fungal infections. We believe that rezafungin could have a significant impact on the lives of patients battling difficult-to-treat and often deadly Candida infections.”
Christine Ann Miller, president and chief executive officer of Melinta Therapeutics, added, "We are very pleased with the publication of the ReSTORE trial results in The Lancet, which like the Phase 2 study, demonstrate a consistent efficacy and safety profile of rezafungin as compared to caspofungin. We look forward to leveraging our established commercial infrastructure and experience in marketing infectious disease products, especially within the hospital and acute care settings, to make rezafungin available to physicians and their patients with candidemia and invasive candidiasis if approved.”
Melinta announced earlier this year that it had acquired the exclusive rights to commercialize rezafungin in the U.S. from Cidara.
Cidara reported positive topline results from ReSTORE in December 2021. Rezafungin met the primary endpoint for the U.S. Food and Drug Administration (FDA) New Drug Application (NDA) submission of all-cause mortality at Day 30, and also met the primary endpoint for the European Medicines Agency (EMA) Marketing Authorization Application (MAA) submission of global cure at Day 14. In the study, researchers evaluated one 400 milligram (mg) dose of rezafungin for the first week followed by 200 mg of rezafungin dosed once-weekly for up to four weeks in total. Rezafungin was generally well tolerated and had a similar safety profile to caspofungin.
The FDA has accepted for filing and granted Priority Review to Cidara’s NDA for rezafungin for the treatment of candidemia and invasive candidiasis. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of March 22, 2023, enabled by rezafungin’s designation as a Qualified Infectious Disease Product (QIDP) and has indicated that the application will be discussed during a scheduled meeting of the Antimicrobial Drugs Advisory Committee on January 24, 2023.
Cidara retains the rights to rezafungin in Japan and in addition to licensing the commercial rights to Melinta in the U.S., has licensed the commercial rights in all other geographies to Mundipharma.
About Rezafungin
Rezafungin is a novel once-weekly echinocandin being developed for both the treatment and prevention of serious fungal infections, such as candidemia and invasive candidiasis. The structure and properties of rezafungin are specifically designed to improve upon a clinically validated mechanism intended to enhance its efficacy and safety potential for patients. Cidara has completed a Phase 3 clinical trial with rezafungin for the treatment of candidemia and/or invasive candidiasis (ReSTORE trial) and is currently conducting a second Phase 3 clinical trial of rezafungin for the prevention of invasive fungal disease in patients undergoing allogeneic blood and marrow transplantation (ReSPECT trial). Rezafungin has been designated a QIDP with Fast Track status by the FDA, and has been granted Orphan Drug Designation for its use in the treatment of invasive candidiasis in both the U.S. and EU.
About Cidara Therapeutics
Cidara is developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases. The Company’s portfolio is comprised of new approaches aimed at transforming existing treatment and prevention paradigms, first with its lead Phase 3 antifungal candidate, rezafungin, in addition to drug-Fc conjugates (DFCs) targeting viral and oncology diseases from Cidara’s proprietary Cloudbreak® platform. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.
About Melinta Therapeutics
Melinta Therapeutics, LLC provides innovative therapies to people impacted by acute and life-threatening illnesses. Our portfolio currently includes six commercial-stage products: Baxdela® (delafloxacin), Kimyrsa® (oritavancin), Minocin® (minocycline) for Injection, Orbactiv® (oritavancin), TOPROL-XL® (metoprolol succinate) and Vabomere® (meropenem and vaborbactam). Melinta also has a licensing agreement in place with Cidara Therapeutics securing the rights to market and distribute the development candidate, rezafungin in the United States.
With an unsurpassed commitment to providers and the patients they serve, we work to ensure that all people who need our therapies can receive them. 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. For additional information, including product and respective important safety information, please visit our website.
TOPROL-XL® is a registered trademark of AstraZeneca Pharmaceuticals LP and is used with permission.
Forward-Looking Statements
This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “anticipates,” “expect,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to our expectations regarding whether the FDA will approve the filed rezafungin NDA on or around the PDUFA target action date or at all, whether the ReSPECT trial for prophylaxis will be completed, if rezafungin is approved in the U.S., when a commercial launch of rezafungin will occur. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, such as unanticipated delays in or negative results from Cidara’s pre-clinical or clinical trials, delays in action by regulatory authorities due to limitations on inspections and other COVID-19-related effects, and impacts of the COVID-19 pandemic or other obstacles on the enrollment of patients or other aspects of rezafungin development. These and other risks are identified under the caption “Risk Factors” in Cidara’s most recent Quarterly Report on Form 10-Q and other filings subsequently made with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Cidara does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.
CIDARA INVESTOR CONTACT:
Brian Ritchie
LifeSci Advisors
(212) 915-2578
britchie@lifesciadvisors.com
CIDARA MEDIA CONTACT:
Patrick Bursey
LifeSci Communications
(203) 430-9545
pbursey@lifescicomms.com
MELINTA CONTACT:
Susan Blum
908-617-1300
info@melinta.com
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