Cidara Therapeutics Announces New Data for Rezafungin at the 21st ICHS Symposium

Rhea-AI Summary

Cidara Therapeutics (Nasdaq: CDTX) announced new analyses from the completed Phase 2 STRIVE trial for rezafungin, a once-weekly echinocandin, demonstrating safety and efficacy in treating candidemia and invasive candidiasis among high-risk immunocompromised patients. The overall response rate was 75% in patients treated with rezafungin compared to 66.7% for the standard of care. Additionally, rezafungin's efficacy remained unaffected by renal impairment. Cidara is advancing rezafungin through Phase 3 trials for candidemia and invasive fungal disease prevention.

Positive

• 75% overall response rate for rezafungin in high-risk immunocompromised patients vs 66.7% for standard of care.
• Efficacy of rezafungin not adversely affected by renal impairment.
• Advancement of rezafungin to Phase 3 trials for candidemia and prevention of invasive fungal disease.

Negative

• None.

New analyses from completed Phase 2 STRIVE trial support once-weekly, long-acting rezafungin for the treatment of candidemia and invasive candidiasis in high-risk patient populations

SAN DIEGO, Feb. 17, 2021 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing long-acting therapeutics designed to transform the standard of care for patients facing serious fungal or viral infections, today announced data from three posters at the 21^st International Immunocompromised Host Society (ICHS) Symposium on Infections in the Immunocompromised Host, which takes place virtually Feb. 17-19, 2021. The presentations highlight new clinical and preclinical data on rezafungin, Cidara’s novel, once-weekly echinocandin in Phase 3 development for the treatment and prevention of serious fungal infections.

"We are delighted to present data describing the recent highlights from our antifungal program,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. "We are gathering critical insights into potential patient outcomes through exploratory analyses of the completed Phase 2 STRIVE trial of our novel long-acting echinocandin, rezafungin, for the treatment of candidemia and/or invasive candidiasis. We believe rezafungin has the potential to improve outcomes, particularly in high-risk populations, including immunocompromised and critically ill patients with severe comorbidities.”

Three poster presentations report new findings on rezafungin for the treatment and prevention of severe fungal infections. Taylor Sandison, M.D., M.P.H., chief medical officer of Cidara, will also be delivering an oral overview of long-acting rezafungin. Highlights from the published abstracts are as follows:

• Analysis of outcomes from the completed Phase 2 STRIVE trial of rezafungin for the treatment of candidemia and/or invasive candidiasis based on immunocompromised status demonstrated rezafungin was safe and efficacious in a high-risk, immunocompromised patient population; the overall response rate, investigator-assessed clinical cure and mycological response at Day 14 was 75% (9/12) in high-risk immunocompromised patients treated with rezafungin compared to 66.7% (6/9) in those treated with standard of care (caspofungin).
• Additional evaluation of patient outcomes from the STRIVE trial based on renal function demonstrated that the safety and efficacy of rezafungin were not adversely affected by renal impairment, a common comorbidity in critically ill patients with invasive fungal infections.
• Administration of long-term (up to eight weeks of) rezafungin initiated six weeks post-infection with P. murina resulted in robust eradication of Pneumocystis in the lungs in immunosuppressed mice.  
  

Presentation details will be accessible on the Publications section of the Cidara website at the conclusion of the conference.

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 is currently conducting a Phase 3 clinical trial with rezafungin for the first-line treatment of candidemia and/or invasive candidiasis (ReSTORE trial) and a second Phase 3 clinical trial of once-weekly rezafungin for the prevention of invasive fungal disease in patients undergoing allogeneic blood and marrow transplantation (ReSPECT trial).

About Cidara Therapeutics
Cidara is developing long-acting therapeutics designed to transform the standard of care for patients facing serious fungal or viral infections. The Company’s portfolio is comprised of its lead antifungal candidate, rezafungin, in addition to antiviral conjugates (AVCs) for the prevention and treatment of influenza and other viral diseases from Cidara’s proprietary Cloudbreak® antiviral 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 the potential for rezafungin to improve patient outcomes in high risk populations. 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 clinical trials, impacts of the COVID-19 pandemic on patient enrollment or other obstacles to the development of rezafungin. 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:
Karen O’Shea, Ph.D.
LifeSci Communications
(929) 469-3860
koshea@lifescicomms.com

FAQ

What were the findings of the Phase 2 STRIVE trial for CDTX?

The Phase 2 STRIVE trial showed a 75% response rate for rezafungin in high-risk immunocompromised patients compared to 66.7% for the standard of care.

How does rezafungin perform in patients with renal impairment?

The trial results indicated that the safety and efficacy of rezafungin were not adversely affected by renal impairment.

What is the next step for rezafungin after the STRIVE trial?

Cidara is advancing rezafungin into Phase 3 trials for both the treatment of candidemia and prevention of invasive fungal disease.

When was the data from the STRIVE trial presented?

The data was presented at the 21st International Immunocompromised Host Society Symposium on February 17-19, 2021.