Antifungal: Rezafungin

Cidara is developing a novel once-weekly echinocandin, rezafungin, 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, enhancing its efficacy and safety potential for patients.

Overview

Treatment

Prevention

Rezafungin is a novel, once-weekly antifungal being developed for the treatment and prevention of serious fungal infections.

Rezafungin is a member of the echinocandin class of drugs. Echinocandins are considered the safest antifungal drugs available and are suggested by the Infectious Disease Society of America (IDSA) as first-line treatment for fungal infections. Rezafungin’s structure and properties have been precisely refined to retain the safety benefits of echinocandin drugs while enhancing its pharmacokinetic and pharmacodynamic properties to create a longer-lasting, next-generation treatment and preventative, capable of addressing even drug-resistant species.

Rezafungin’s structure yields greater stability, allowing for an extended half-life and improved safety profile.

To date, data demonstrate that rezafungin has potent antifungal activity against representative strains of Candida spp., Aspergillus spp., Pneumocystis spp. and dermatophytes. In addition, rezafungin has potent activity against fungal pathogens designated as Urgent and Serious Threats by the CDC.

Source: CDC, Report on Antibiotic Resistant Threats. Updated Dec 2019.

An ongoing Phase 3 trial (ReSTORE; NCT03667690) is examining rezafungin for the treatment of fungal infections caused by Candida spp., including candidemia and invasive candidiasis.

An ongoing Phase 3 trial (ReSPECT; NCT04368559) is examining rezafungin for the prevention of fungal infections, caused by Candida, Aspergillus and Pneumocystis, in patients undergoing allogeneic blood and marrow transplant.

The U.S. Food and Drug Administration (FDA) has designated rezafungin as a Qualified Infectious Disease Product (QIDP) and a Fast Track Product for both the treatment of candidemia and invasive candidiasis and for prevention of invasive fungal infections in adults undergoing allogeneic hematopoietic stem cell transplantation. The FDA has also designated rezafungin as an orphan drug for the treatment indication. The 7-year period of marketing exclusivity provided through orphan designation combined with an additional 5 years of marketing exclusivity provided by the QIDP designation positions rezafungin for a potential total of 12 years of marketing exclusivity to be granted at the time of FDA approval.

Expanded Access Policy

Cidara is a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel anti-infectives for the treatment or prevention of diseases that are inadequately addressed by current standard of care therapies. We conduct clinical trials to assess the safety and efficacy of our investigational new drugs. The establishment of the safety and efficacy of our investigational new drugs helps us obtain approvals from regulatory agencies such as the FDA. Regulatory approvals are required before these investigational new drugs can be made generally available to patients. We encourage awareness of our clinical trials and believe that participating in clinical trials is an appropriate way for physicians and patients to access investigational new drugs prior to regulatory approval.

At this time, we will consider requests to allow patients access to our investigational new drugs prior to FDA approval on a case-by-case basis, using pre-established criteria to assure a comprehensive internal review process which may not result in access for all requestors. Physicians interested in requesting expanded access on behalf of their patients may contact Cidara at expandedaccess@cidara.com. Requests should include a brief de-identified patient history and the reason why treatment is being requested for the patient. Once Cidara has received the request, we will acknowledge receipt within two (2) business days and, once all required medical information is provided, Cidara will respond in no more than five (5) business days. Individuals interested in clinical trials sponsored by Cidara may visit www.clinicaltrials.gov for information on our ongoing clinical trials.

Cidara may revise this expanded access policy at any time. Additionally, the posting of this policy by Cidara shall not serve as a guarantee of access to any specific investigational new drug by any individual patient.

Dated: May 1, 2020