CAMBRIDGE -
The EMA considers ODD status for medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than five per 10,000 people in the EU.5 It is estimated that IC occurs in around 0.84 per 10,000 people in the EU,6 and mostly affects hospitalised, immunocompromised or critically ill patients.2
IC continues to be an area of significant unmet need, especially for critically ill patients in hospitals and patients with compromised immune systems. Despite a number of available treatments, mortality rates are as high as 40%.3 IC is characterised as a severe, life-threatening systemic Candida infection of the bloodstream and/or deep/visceral tissues, known as candidaemia and deep-seated tissue candidiasis.1
About Rezafungin
Rezafungin is a novel once-weekly echinocandin being developed for both the treatment and prevention of severe fungal infections. Echinocandins are a class of antifungal drugs that act by inhibiting (1,
In studies to date, rezafungin has demonstrated a unique pharmacokinetic profile with a prolonged half-life and is also dosed for front-loaded plasma exposure which, in contrast to all other echinocandins, is intended to allow for once-weekly IV therapy for inpatient and outpatient use.8In Vitro data demonstrate that rezafungin has potent antifungal activity against representative strains of Candida spp, Aspergillus spp, and Pneumocystis spp.9,10 Data from the Phase 2 STRIVE study showed that rezafungin met all of its objectives for safety, tolerability and efficacy in the treatment of patients with candidaemia and/or IC.11
Rezafungin is currently in Phase 3 development. The ReSTORE trial (NCT03667690) is an ongoing, global, randomised, double-blind, controlled, pivotal Phase 3 study to evaluate the safety, tolerability and efficacy of rezafungin compared to caspofungin for the treatment of candidemia and IC in approximately 184 qualifying patients. The primary efficacy outcome measure for the EMA is Global Cure at Day 14 while the primary efficacy outcome measure for the FDA is All-Cause Mortality at Day 30. The ReSPECT trial (NCT04368559) is an ongoing global, randomised, double-blind, controlled, pivotal Phase 3 trial of rezafungin versus the standard antimicrobial regimen to prevent invasive fungal disease due to Candida, Aspergillus and Pneumocystis in subjects undergoing allogeneic blood and marrow transplantation. The trial is expected to enroll approximately 462 adults with underlying conditions, and receive either rezafungin or the standard antimicrobial regimen for 90 days, at which time fungal-free survival will be measured as the primary efficacy outcome.
About
As a dynamic, forward-looking organisation we are dedicated to bringing innovative treatments to patients in the areas of Pain &
Our guiding principles, centred around Integrity and Patient-Centricity, are at the heart of everything we do.
About
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
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 rezafungin's efficacy and potential as a once-weekly treatment and its ability to prevent severe fungal infections and disease. 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 most recent Quarterly Report on Form 10-Q and other filings subsequently made with the
Contact:
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Email: rob.gallo@mundipharma.com
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