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Cidara Therapeutics Highlights New Data from Multiple Rezafungin Studies Presented at ECCMID 2019
Data featured in three oral and five poster presentations reinforce potential of novel antifungal for the treatment and prevention of serious invasive infections
Three oral presentations at ECCMID showcased results from nonclinical and in vivo studies that demonstrate the potential of rezafungin to fight and protect against difficult-to-treat fungal infections. Additionally, researchers presented five rezafungin posters at the meeting, including new analyses from Cidara’s Phase 2 STRIVE trial investigating rezafungin for the treatment of candidemia and invasive candidiasis.
“Collectively, the data presented at ECCMIDthis year underscore
our commitment to developing rezafungin to its full potential in
multiple, serious infections where there is urgent need for innovation.
We are particularly excited by new data from in vivo studies that
demonstrated rezafungin efficacy in prevention of Pneumocystis infection
as well as in treatment of intra-abdominal Candida infections,”
Overall, the rezafungin presentations at ECCMID demonstrate the novel agent’s potent antifungal activity and distinct pharmacokinetic and pharmacodynamic profile that together provide for prolonged drug exposure and stable, long-acting efficacy. In addition, analyses of STRIVE study data reinforce rezafungin’s broad efficacy, safety and reliability across a variety of patient populations, including those with impaired renal function.
“The data presented at ECCMID provide further evidence of the potential
safety and efficacy of rezafungin as a novel once-weekly antifungal for
the treatment and prevention of invasive fungal infections, which are
particularly pervasive in immunocompromised patients,”said Juan
P. Horcajada, M.D., Ph.D., chief of the
Key findings from the three rezafungin ECCMID oral presentations are summarized below.
Title: Rezafungin is more effective than micafungin in treating FKS-mutant Candida glabrata intra-abdominal candidiasis: This study compared the in vivo activity of rezafungin to micafungin in an intra-abdominal candidiasis (IAC) infection model. Researchers concluded that rezafungin achieved greater and more prolonged penetration at the sites of IAC than the standard-of-care therapy micafungin, which correlated with significantly greater rezafungin activity against FKS mutant Candida glabrata, a species known to harbor multidrug resistance. Rezafungin also demonstrated greater effectiveness with once-weekly dosing than with micafungin dosed once daily, supporting the potential for extended dosing intervals in patients, and the potential of rezafungin as a treatment and a prophylactic agent against IAC.
Title: Rezafungin PK/PD in a mouse model of Pneumocystis pneumonia: This presentation highlighted results from two in vivo studies of rezafungin as prophylaxis in a mouse model of Pneumocystis pneumonia (PCP). Based on the study findings, researchers concluded that exposures of rezafungin needed for PCP prophylaxis will be achieved in most patients (≥ 90%) with doses as low as 50 mg per week. This finding supports the dose-selection rationale of rezafungin for PCP prophylaxis and also highlights the benefits of the front-loaded drug exposure curve of rezafungin versus a conventional daily exposure curve.
Title: EUCAST susceptibility testing of rezafungin: MIC data for contemporary Danish clinical yeast isolates: Using the EUCAST susceptibility testing model, this study evaluated the in vitro activity of rezafungin and comparators (anidulafungin, micafungin, amphotericin B, voriconazole and fluconazole) against 404 Danish clinical yeast isolates, including common Candida spp. isolates and isolates with non-wild-type minimum inhibitory concentration (MIC) values. The study showed that resistant isolates to rezafungin were rare and less frequent as compared to the other drugs. These results contribute to the EUCAST-based international in vitro surveillance MIC dataset for rezafungin and support its ongoing clinical development for the treatment of candidemia and invasive candidiasis.
Cidara also presented new analyses of the Phase 2 STRIVE data at ECCMID. STRIVE was an international, multicenter, double-blind, trial evaluating the safety, tolerability and efficacy of once-weekly intravenous (IV) dosing of rezafungin compared to once-daily dosing of caspofungin in patients with candidemia and/or invasive candidiasis (IC). Findings from these poster presentations are summarized below.
Title: Phase II STRIVE clinical trial of rezafungin for the treatment of candidemia and/or invasive candidiasis: results stratified by baseline renal function: This presentation highlights results from an analysis of the completed Part A of the STRIVE trial, in which researchers stratified patients treated with rezafungin by baseline renal function and classified them into the following categories: those with creatinine clearance (CrCl, normalized for body surface area) ≥60 mL/min/1.73 m2 and those with CrCl <60 mL/min/1.73 m2. Researchers evaluated data for differences in safety, efficacy, or pharmacokinetics between renal categories. The analysis found no meaningful trends in outcomes based on renal function, suggesting renal elimination is not an important route of rezafungin clearance.
Title: Outcomes in
All rezafungin abstracts can be accessed through the ECCMID website: www.eccmid.org. Following the meeting, the presentation slides and posters will be available on the Cidara website: www.cidara.com.
Rezafungin, currently in Phase 3 testing, is a novel antifungal echinocandin being developed as a once-weekly, high-exposure therapy for the treatment and prevention of serious invasive fungal infections. Rezafungin has a unique pharmacokinetic profile with a prolonged half-life and front-loaded plasma exposure which, in contrast to all other echinocandins, allows for once-weekly IV therapy. Rezafungin is being developed to address unmet needs in the treatment of candidemia and invasive candidiasis as well as for prophylaxis (prevention) of invasive fungal infections in patients undergoing allogeneic blood and marrow transplantation.
About Invasive Fungal Infections
Invasive fungal infections (IFIs) represent a serious global health threat, resulting in more than 1.5 million deaths annually and mortality rates ranging from 15 to 65 percent. These infections are especially relevant for patients whose immune systems have been compromised, such as patients undergoing organ or blood and marrow transplantation or chemotherapy, including patients with hematologic malignancies. Of the most significant IFIs, approximately 90 percent of related deaths are primarily caused by Candida, Aspergillus, and Pneumocystis. Candida species are most common in hospital-acquired infections, while Aspergillus species are predominant in patients with weakened immune systems or lung diseases. Pneumocystis infections also commonly afflict immunocompromised patients.
Cidara is a clinical-stage biotechnology company focused on the
discovery, development and commercialization of novel anti-infectives
that have the potential to transform the standard of care and save or
improve patients’ lives. Cidara is currently advancing its novel
echinocandin antifungal, rezafungin acetate, in a Phase 3 clinical trial
for the treatment of candidemia and invasive candidiasis, and continues
to discuss with regulatory authorities its plans for the design and the
initiation of a second Phase 3 trial in the prophylaxis of invasive
fungal infections in patients undergoing allogeneic blood and marrow
transplantation. Rezafungin is the only once-weekly product candidate in
development for the treatment and prevention of life-threatening
invasive fungal infections. Cidara also is leveraging its proprietary
Cloudbreak® platform to develop antiviral conjugates (AVCs)
for serious infections, including further investigation of the high
potency and long half-life observed in its AVCs for influenza. The
Cloudbreak platform is designed to discover compounds that both directly
kill pathogens and direct a patient’s immune system to attack and
eliminate pathogens. Cidara is headquartered in
Statements contained in this press release regarding matters that are
not historical facts are "forward-looking statements" within the meaning
of the Private Securities Litigation Reform Act of 1995. Because such
statements are subject to risks and uncertainties, actual results may
differ materially from those expressed or implied by such
forward-looking statements. Such statements include, but are not limited
to, the potential for rezafungin to successfully treat or prevent
invasive fungal infections and represent an improvement over current
approaches, the potential for rezafungin in high-risk patient
populations and Cidara’s ability to successfully develop rezafungin.
Risks that contribute to the uncertain nature of the forward-looking
statements include: the success and timing of Cidara’s preclinical
studies and clinical trials; regulatory developments in
Robert H. Uhl
Westwicke Partners, LLC
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