Cidara Therapeutics to Present New Data for Rezafungin at IDWeek 2022

Rhea-AI Summary

On October 17, 2022, Cidara Therapeutics (NASDAQ: CDTX) announced its participation in IDWeek 2022, presenting new clinical data for rezafungin, a novel antifungal therapy, via six poster presentations. Rezafungin is aimed at treating candidemia and invasive candidiasis, with a target action date from the FDA set for March 22, 2023. The drug has received QIDP designation and Orphan Drug Designation in the U.S. and EU. Cidara retains rights in Japan and has licensed U.S. rights to Melinta Therapeutics. The company is focused on improving treatment options for serious diseases.

SAN DIEGO, Oct. 17, 2022 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ: CDTX), a biotechnology company developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases, today announced that it is presenting new clinical and preclinical data for rezafungin in six poster presentations at IDWeek taking place in-person in Washington, D.C. from October 19-23, 2022. The company will also participate in a pipeline symposium focused on new antimicrobials and ID diagnostics.

Rezafungin is a novel, once-weekly echinocandin antifungal being developed for the treatment of candidemia and invasive candidiasis, as well as for the prophylaxis of invasive fungal infections in patients undergoing allogeneic blood and marrow transplant. Cidara’s New Drug Application (NDA) for rezafungin for the treatment of candidemia and invasive candidiasis has been accepted by the U.S. Food and Drug Administration (FDA) and the company has been 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). QIDP designation is reserved for antibacterial and antifungal drug candidates intended to treat serious or life-threatening infections. Additionally, rezafungin has been granted Orphan Drug Designation for its use in the treatment of invasive candidiasis in both the U.S. and EU.

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

Presentation details:

Title: Outcomes by Baseline Pathogen and Susceptibility in the ReSTORE Phase 3 Trial of Rezafungin Once Weekly Compared with Caspofungin Once Daily in Patients with Candidemia and/or Invasive Candidiasis 
Presenter: George R. Thompson III, M.D., UC Davis
Session Title: Clinical trials
Poster Number: 231
Date and Time: Thursday October 20, 2022, at 12:15 PM - 1:30 PM EDT

Title: Impact of Elevated MIC Values on Echinocandin Pharmacokinetic-Pharmacodynamic (PK-PD) Candida glabrata Target Attainment (TA)
Presenter: Chris Rubino, Pharm.D., ICPD
Session Title: PK/PD studies
Poster Number: 592
Date and Time: Thursday October 20, 2022, at 12:15 PM - 1:30 PM EDT

Title: Assessment of The Proportion of Hospitalized Patients (Pts) with Candidemia (C) and Invasive Candidiasis without Candidemia (IC) Who Received an Echinocandin (EC) and Were Potentially Eligible for an Earlier Hospital Discharge (HD) 
Lead Author: Tom Lodise, Pharm.D., Ph.D., Albany College of Pharmacy and Health Sciences
Session Title: Medical Mycology
Poster Number: 468
Date and Time: Thursday October 20, 2022, at 12:15 PM - 1:30 PM EDT

Title: Healthcare Resource Utilization (HRU) among Hospitalized Patients (Pts) with Candidemia (C) and Invasive Candidiasis without Candidemia (IC) Who Received Definitive Treatment with an Echinocandin (EC) Across United States (US) Hospitals 
Presenter: Tom Lodise, Pharm.D., Ph.D., Albany College of Pharmacy and Health Sciences
Session Title: Medical Mycology
Poster Number: 469
Date and Time: Thursday October 20, 2022, at 12:15 PM - 1:30 PM EDT

Title: Rezafungin Activity against Candida spp. and Aspergillus spp. Isolates Causing Invasive Infections Worldwide in 2021
Presenter: Cecilia Carvalhaes, M.D., Ph.D., D(ABMM), JMI Laboratories
Session Title: Antimicrobial Novel Agents
Poster Number: 1731
Date and Time: Saturday October 22, 2022, at 12:15 PM - 1:30 PM EDT

Title: Coadministration of Rezafungin Does Not Impact the Pharmacokinetics of Cyclosporine, Ibrutinib, Mycophenolate Mofetil, or Venetoclax 
Presenter: Taylor Sandison, M.D., MPH, Cidara
Session Title: Antimicrobial Novel Agents
Poster Number: 1694
Date and Time: Saturday October 22, 2022, at 12:15 PM - 1:30 PM EDT

Pipeline Symposium details:

Session Title: New Antimicrobials and ID Diagnostics in the Pipeline - Fungal
Presenter: Taylor Sandison, M.D., MPH, Cidara
Location: 145 AB
Date and Time: Saturday October 22, 2022, at 8:00 AM - 9:00 AM EDT

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.

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, and whether the ReSPECT data will be sufficient to support submission of a supplemental NDA application for the prophylaxis indication. 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.

INVESTOR CONTACT:
Brian Ritchie
LifeSci Advisors
(212) 915-2578
britchie@lifesciadvisors.com

MEDIA CONTACT:
Patrick Bursey
LifeSci Communications
(203) 430-9545
pbursey@lifescicomms.com

FAQ

What is rezafungin and its significance for Cidara Therapeutics (CDTX)?

Rezafungin is a novel once-weekly antifungal therapy being developed by Cidara Therapeutics for the treatment of serious fungal infections like candidemia and invasive candidiasis.

When is the FDA action date for rezafungin's New Drug Application?

The FDA has set the Prescription Drug User Fee Act (PDUFA) target action date for rezafungin's NDA as March 22, 2023.

What designations has rezafungin received from the FDA?

Rezafungin has received Qualified Infectious Disease Product (QIDP) designation and Orphan Drug Designation for treating invasive candidiasis.

Where will Cidara present data on rezafungin?

Cidara will present new clinical and preclinical data for rezafungin at IDWeek 2022 in Washington, D.C. from October 19-23, 2022.

What partnerships does Cidara have regarding rezafungin?

Cidara has licensed the commercial rights for rezafungin to Melinta Therapeutics in the U.S. and Mundipharma Medical in other regions.