Cidara Therapeutics Announces New Clinical and Preclinical Data for Rezafungin and Influenza AVCs at IDWeek 2020
Presentations highlight clinical and preclinical progress of long-acting drug candidates for serious fungal and viral infections
Posters presenting new analyses from completed Phase 2 STRIVE trial support the efficacy and pharmacokinetics of once-weekly rezafungin in the treatment of candidemia and invasive candidiasis
Oral and poster presentations highlight potential of antiviral conjugates (AVCs) for universal prevention and treatment of influenza
"We are pleased to share new clinical and preclinical data from our antifungal and antiviral programs at IDWeek 2020,” said
Five of the poster presentations report new findings on rezafungin, Cidara’s novel, Phase 3, once-weekly echinocandin being developed for the treatment and prevention of serious fungal infections, and on patterns of echinocandin use. Highlights from these published abstracts are as follows:
- Analyses from the completed Phase 2 STRIVE trial of rezafungin for treatment of candidemia and/or invasive candidiasis demonstrate rezafungin pharmacokinetics (PK) were consistent across diverse patient populations, with no meaningful differences observed across a wide range of patient factors, including sex, race, age and body weight.
- Analysis of patient outcomes stratified by Candida species from the STRIVE trial demonstrated the efficacy of rezafungin across multiple Candida species, with similar or better outcomes observed with rezafungin compared to standard of care, caspofungin.
- Results from an excretion balance, metabolism and PK study in healthy adults showed that fecal excretion of unmetabolized drug is the major route of elimination of rezafungin in humans, consistent with preclinical results from rats and monkeys.
- Pharmacoepidemiologic analysis of echinocandin use during hospitalization and upon discharge, at a large, quaternary care medical center showed that a significant portion of echinocandin courses continued after hospital discharge, where a long-acting echinocandin could be of benefit.
Two oral and two poster presentations report new findings from Cidara’s Cloudbreak antiviral platform, specifically the AVC development candidate, CD377, for prevention and treatment of influenza. Data highlights from the published abstracts on CD377 are as follows:
- A single dose of CD377 was protective against lethal challenge with a panel of seasonal and pandemic influenza subtypes in mice, demonstrating its potent broad-spectrum activity.
- CD377 demonstrated superior dose-dependent viral load reduction in the lung compared to approved influenza treatment oseltamivir in lethal influenza mouse and ferret models.
- Additional data in mice demonstrated the efficacy of a single dose of CD377 in both prevention and treatment of influenza infection. CD377 administered 28 days prior to infection completely protected against several strains of influenza, and treatment efficacy was observed with a single dose of CD377 72- hours-post infection. High bioavailability of CD377 (77%) was observed after subcutaneous or intramuscular administration. PK studies performed in mice, rats, ferrets and monkeys demonstrated that CD377 is stable and has a long half-life, with no adverse effects observed in a monkey toxicology study.
- Further studies demonstrated the efficacy of CD377 in both immune-competent and immune-deficient mice lethally challenged with influenza, with similar PK and potent in vitro activity observed at equivalent doses irrespective of immune status.
Presentation details will be accessible on the Publications section of the Cidara website at the conclusion of the conference.
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 Cloudbreak AVCs
Cidara is developing a new generation of immunotherapeutic antivirals from its Cloudbreak antiviral platform that couple potent antivirals to a human antibody fragment. These long-acting, antiviral conjugates (AVCs) directly inhibit viral proliferation while simultaneously engaging the immune system. AVCs are initially being studied for the prevention and treatment of seasonal and pandemic influenza, with the potential to deliver universal protection for an entire flu season with a single dose. Cidara is also advancing preclinical and discovery AVC programs to target other life-threatening viruses, such as RSV, HIV and CoV, including COVID-19.
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
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 rezafungin’s efficacy and potential as a once-weekly treatment and its ability to prevent severe fungal infections and disease, our Cloudbreak AVCs’ potential to directly inhibit viral proliferation while simultaneously engaging the immune system, and the ability of our influenza AVC to treat and deliver universal protection for an entire flu season with a single dose. 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 or pre-clinical studies or other obstacles to the development of rezafungin or Cidara’s Cloudbreak AVCs. 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
Karen O’Shea, Ph.D.
Source: Cidara Therapeutics, Inc.