Cidara Therapeutics Announces Completion of Enrollment in Phase 3 Restore Trial of Rezafungin in China

Rhea-AI Summary

Cidara Therapeutics, Inc. (Nasdaq: CDTX) has completed enrollment in the Phase 3 ReSTORE trial in China evaluating the efficacy and safety of rezafungin as a treatment for candidemia and invasive candidiasis. The trial included 52 patients and is expected to provide top-line data in Q2 2024. Rezafungin has received FDA approval in the U.S. and a positive CHMP opinion in the EU, with a final decision expected soon. Melinta Therapeutics has exclusive commercialization rights to REZZAYOTM in the U.S., and Mundipharma has rights in all other geographies except the U.S. and Japan.

Positive

• Completion of the trial enrollment is a significant step in bringing a new treatment option for difficult to treat candidemia and invasive candidiasis.
• Rezafungin has demonstrated benefits for patients in the U.S. and E.U., with potential to target a broader global patient population.
• Reduction in cash burn and potential for additional regulatory and commercial milestone payments upon completion of the trial.

Negative

• None.

• Top-line data expected in Q2 2024
  

SAN DIEGO, Dec. 06, 2023 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology developing therapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced the company, along with Mundipharma, has completed enrollment in the Phase 3 ReSTORE trial in China evaluating the efficacy and safety of rezafungin as a treatment for candidemia and invasive candidiasis.

The portion of the trial conducted in China included 52 patients diagnosed with candidemia and/or invasive candidiasis. ReSTORE (NCT03667690) is a global, randomized, double-blind, controlled Phase 3 pivotal clinical trial evaluating the efficacy and safety of once-weekly intravenous dosing of rezafungin compared to once-daily dosing of caspofungin, the current standard of care, to treat patients with candidemia and/or invasive candidiasis. 

“The completion of this trial enrollment marks a significant step in our efforts to bring an important treatment option to patients living with difficult to treat candidemia and invasive candidiasis,” said Taylor Sandison, M.D., MPH, chief medical officer of Cidara. “Rezafungin has demonstrated its benefit for patients in the U.S. and E.U., and now there is the potential to target an even broader global patient population who are suffering and in need of a new treatment option.”

Jeffrey Stein, Ph.D., president and chief executive officer of Cidara stated, “We appreciate the hard work of our investigators involved in this trial, and the patients who have helped us achieve this key milestone. Our team looks forward to the availability of the results of this study in the second quarter of next year and the potential to expand the reach of this treatment for patients. Moreover, the completion of this trial will reduce our cash burn longer-term and makes us eligible to receive additional regulatory and commercial milestone payments.”

Rezafungin received U.S. Food and Drug Administration approval in the U.S. earlier this year, as well as a positive CHMP opinion in October for patients in the European Union. A final decision by the European Medicines Agency (EMA) is expected to be delivered next month. Melinta Therapeutics has the exclusive commercialization rights to REZZAYO^TM (rezafungin for injection) in the U.S. and Mundipharma has the commercialization rights to rezafungin in all geographies other than the U.S. and Japan.

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 whether rezafungin will be approved for sale in Europe by the European Commission, whether the ReSTORE trial results in China will be similar to those observed in other geographies and whether rezafungin will ultimately be approved and commercialized in China. 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.

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

MEDIA CONTACT:
Veronica Eames
LifeSci Communications
(646) 970-4682
veames@lifescicomms.com

FAQ

What is the purpose of the Phase 3 ReSTORE trial conducted by Cidara Therapeutics, Inc. (Nasdaq: CDTX)?

The trial evaluates the efficacy and safety of rezafungin as a treatment for candidemia and invasive candidiasis.

How many patients were included in the Phase 3 ReSTORE trial conducted by Cidara Therapeutics, Inc. (Nasdaq: CDTX)?

The trial included 52 patients diagnosed with candidemia and/or invasive candidiasis.

When is the top-line data expected from the Phase 3 ReSTORE trial conducted by Cidara Therapeutics, Inc. (Nasdaq: CDTX)?

The top-line data is expected in Q2 2024.

What regulatory approvals has rezafungin received?

Rezafungin received FDA approval in the U.S. and a positive CHMP opinion in the EU, with a final decision expected soon.

Who has the exclusive commercialization rights to REZZAYOTM in the U.S.?

Melinta Therapeutics has the exclusive commercialization rights to REZZAYOTM in the U.S.