Melinta Therapeutics & Cidara Therapeutics Announce Publication of Pooled Data from Phase 3 Pivotal ReSTORE Trial & Phase 2 STRIVE Trial of REZZAYO® (rezafungin for injection) for the Treatment of Candidemia & Invasive Candidiasis in The Lancet ID

Rhea-AI Summary

Melinta Therapeutics, LLC and Cidara Therapeutics, Inc. (NASDAQ: CDTX) have announced the publication of pooled data from two completed global clinical trials evaluating REZZAYO® (rezafungin for injection) for the treatment of candidemia and invasive candidiasis. The publication in The Lancet Infectious Diseases demonstrates the non-inferiority of REZZAYO as compared to caspofungin for all-cause mortality and provides additional evidence for potential early treatment benefits.

Positive

• FDA approval for REZZAYO for the treatment of candidemia and invasive candidiasis
• Positive findings from the ReSTORE Phase 3 trial and the Phase 2 STRIVE trial
• Permanent product-specific J-Code and new technology add-on payment for REZZAYO

Negative

• None.

Publication reaffirms the proven efficacy and safety of rezafungin dosed once-weekly versus a current standard of care echinocandin dosed once-daily

PARSIPPANY, N.J. & SAN DIEGO--(BUSINESS WIRE)-- Melinta Therapeutics, LLC and Cidara Therapeutics, Inc. (NASDAQ: CDTX) today announced the peer-reviewed publication of pooled data from two completed global clinical trials evaluating REZZAYO^® (rezafungin for injection) for the treatment of candidemia and invasive candidiasis. The article, “Efficacy and safety of rezafungin and caspofungin in candidemia and invasive candidiasis: pooled data from two prospective randomised controlled trials,” published in The Lancet Infectious Diseases, reports on pooled data analyses of the pivotal ReSTORE Phase 3 randomized controlled clinical trial, which demonstrated the non-inferiority of REZZAYO as compared to caspofungin for all-cause mortality, and the STRIVE Phase 2 randomized controlled trial, which provided safety and supportive efficacy data for REZZAYO. The pooled analyses in the article further support the non-inferiority of rezafungin versus caspofungin for all-cause mortality and with similar safety profiles and provide additional evidence for potential early treatment benefits.

Christine Ann Miller, president and chief executive officer of Melinta Therapeutics, said, “We are very pleased with the publication of the pooled data from two completed clinical trials, the ReSTORE Phase 3 trial and the Phase 2 STRIVE trial, in Lancet ID, which, combined, continue to demonstrate a consistent efficacy and safety profile of REZZAYO as compared to caspofungin. These findings are of clinical importance given the ongoing morbidity and mortality caused by candidemia and invasive candidiasis. Since the approval of REZZAYO, Melinta has been leveraging our commercial infrastructure and experience in marketing infectious disease products, particularly within the hospital and acute care settings, to make REZZAYO available to healthcare providers and their patients suffering with candidemia and invasive candidiasis.”

Taylor Sandison, MD, MPH, chief medical officer at Cidara Therapeutics, added, “The continued clinical success of REZZAYO across global populations reinforces its potential as a therapeutic option for patients suffering from candidemia and invasive candidiasis.”

The ReSTORE pivotal Phase 3 trial demonstrated that REZZAYO 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. The STRIVE Phase 2 study provided safety and supportive efficacy data on REZZAYO.

In both studies, researchers evaluated one 400 milligram (mg) dose of REZZAYO for the first week followed by 200 mg of REZZAYO dosed once weekly for up to four weeks in total. REZZAYO was generally well tolerated and had a similar safety profile to caspofungin.

On March 22, 2023, the FDA approved REZZAYO for the treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options. REZZAYO is the first new treatment option approved for patients with candidemia and invasive candidiasis in over fifteen years. Based on Qualified Infectious Disease Product (QIDP) designation, REZZAYO was approved under Priority Review. The Centers for Medicare & Medicaid Services (CMS) issued a permanent product-specific J-Code (J0349, Injection, rezafungin, 1 mg) for REZZAYO injection effective October 1, 2023. CMS also granted a new technology add-on payment (NTAP) for REZZAYO for eligible participating hospitals when Medicare patients are treated in the inpatient acute care hospital setting.

Last year, Melinta announced that it had acquired the exclusive rights to commercialize rezafungin in the U.S. from Cidara. Cidara retains the rights to rezafungin in Japan and has licensed the commercial rights to Melinta Therapeutics in the U.S. and Mundipharma in all other geographies. The EMA accepted the MAA for rezafungin in August 2022, and it is currently under review. In October, the EMA Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for rezafungin (rezafungin acetate) for the treatment of invasive candidiasis in adults.

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. The structure and properties of REZZAYO are specifically designed to improve upon a clinically validated mechanism.

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

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

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.

REZZAYO may cause photosensitivity. Advise patients to use protection from sun exposure and other sources of UV radiation.

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.

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.

About Cidara Therapeutics

Cidara Therapeutics is using its proprietary Cloudbreak® platform to develop novel drug-Fc conjugates (DFCs). These targeted immunotherapies offer the unique opportunity to create “single molecule cocktails” comprised of targeted small molecules and peptides coupled to a human antibody fragment (Fc). DFCs are designed to save lives and improve the standard of care for patients facing cancers and other serious diseases by inhibiting specific disease targets while simultaneously engaging the immune system. In addition, Cidara received FDA approval for REZZAYO® (rezafungin for injection), which it has licensed to multiple partners to commercialize in the U.S. and ex-U.S. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.

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,” “believe,” “could,” “expect,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to REZZAYO™ will be included in institutional formularies, prescribed by physicians or reimbursed by payors. . 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. These and other risks are identified under the caption “Risk Factors” in Cidara’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20231205775801/en/

MELINTA MEDIA RELATIONS:

Sharon Dilling

sdilling@melinta.com

CIDARA INVESTOR RELATIONS:

Brian Ritchie

LifeSci Advisors

(212) 915-2578

britchie@lifesciadvisors.com

CIDARA MEDIA RELATIONS:

Veronica Eames

LifeSci Communications

(646) 970-4682

veames@lifescicomms.com

Source: Melinta Therapeutics, LLC

FAQ

What is the significance of the publication in The Lancet Infectious Diseases for Melinta Therapeutics and Cidara Therapeutics, Inc. (NASDAQ: CDTX)?

The publication demonstrates the non-inferiority of REZZAYO as compared to caspofungin for all-cause mortality, providing additional evidence for potential early treatment benefits.

What are the key findings from the ReSTORE Phase 3 trial and the Phase 2 STRIVE trial for REZZAYO?

The ReSTORE Phase 3 trial demonstrated that REZZAYO met the primary endpoint for the U.S. 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. The STRIVE Phase 2 study provided safety and supportive efficacy data on REZZAYO.

What approvals and designations has REZZAYO received?

REZZAYO was approved by the FDA for the treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options. It was also granted Qualified Infectious Disease Product (QIDP) designation and received a permanent product-specific J-Code and new technology add-on payment from CMS.

What are the commercialization rights for rezafungin in the U.S. and other geographies?

Melinta has acquired the exclusive rights to commercialize rezafungin in the U.S. from Cidara. Cidara retains the rights to rezafungin in Japan and has licensed the commercial rights to Melinta Therapeutics in the U.S. and Mundipharma in all other geographies.

What are the regulatory statuses of rezafungin in the U.S. and Europe?

REZZAYO was approved by the FDA, and the EMA accepted the MAA for rezafungin in August 2022, with a positive opinion from the EMA Committee for Medicinal Products for Human Use (CHMP) for the treatment of invasive candidiasis in adults.