Cidara Therapeutics, Inc., 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 two oral abstracts and seven posters at IDWeek 2020, the joint annual meeting of the Infectious Diseases Society of America (IDSA), Society for Healthcare Epidemiology of America (SHEA), the HIV Medical Association (HIVMA), the Pediatric Infectious Diseases Society (PIDS) and the Society of Infectious Diseases Pharmacists (SIDP), taking place virtually Oct. 21-25, 2020.
“We are pleased to share new clinical and preclinical data from our antifungal and antiviral programs at IDWeek 2020,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “Analyses of the completed Phase 2 STRIVE trial of our novel echinocandin, rezafungin, for the treatment of candidemia and/or invasive candidiasis, adds to the body of evidence of rezafungin’s efficacy, specifically against multiple Candida species and across a wide array of patient populations. From our Cloudbreak antiviral program, we are excited to present non-clinical data on our AVC candidate, CD377, supporting its development for universal influenza protection for all people, regardless of immune status.”
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.