Data featured in three oral and five poster presentations
reinforce potential of novel antifungal for the treatment and prevention
of serious invasive infections
SAN DIEGO–(BUSINESS WIRE)–Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company
developing novel anti-infectives including immunotherapies, highlighted
new data from multiple studies of rezafungin, the company’s lead
investigational compound, this week during the 29th European Congress of
Clinical Microbiology and Infectious Diseases (ECCMID) in Amsterdam,
Netherlands. Rezafungin is the only once-weekly product candidate in
development for the treatment and prevention of life-threatening
invasive fungal 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 ECCMID this 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,”
said Jeffrey Stein, Ph.D., president and chief executive officer of
Cidara. “We look forward to continuing our clinical development of
rezafungin as we progress our global Phase 3 ReSTORE treatment trial and
plan for initiation of the Phase 3 ReSPECT prophylaxis trial.”
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 Department of Infectious
Diseases, coordinator of the Infection Control Program and president of
the Infection Control Committee at Hospital del Mar, in Barcelona,
Spain. “Current strategies for treating and preventing these infections
have significant limitations, including toxicity and tolerability
issues, drug-to-drug interactions, and increasing resistance, all of
which complicate therapy in patients who are often already very ill and
on multiple medications. Rezafungin could provide a much needed, new and
effective option. Moreover, once-weekly administration makes a
difference for the practical management of most patients.”
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 Europe from the STRIVE clinical trial of
rezafungin treatment of candidemia and/or invasive candidiasis: In
this analysis, researchers stratified data from the completed Part A of
STRIVE by enrollment region (Europe, N=62; North America [NA], N=45) and
analyzed respective patient demographics and baseline characteristics,
treatment patterns, and outcomes. The STRIVE population in Europe was
generally older and more homogeneous (mean age, 63.7 years; 96.8% white)
than in North America (mean age, 50.7 years; 64.4% white, 26.7% Black or
African-American, 4.4% Asian). Patients in Europe – on average – also
had lower BMI and higher rates of infections caused by non-albicans Candida.
Based on the analyses, researchers concluded that there were no
differentiating trends by geographic region in terms of severity of
illness or efficacy outcomes.
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.
About Rezafungin
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.
About Cidara Therapeutics
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 San Diego, California.
For more information, please visit www.cidara.com.
Forward-Looking Statements
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 the United
States and foreign countries; changes in Cidara’s plans to develop and
commercialize its product candidates; Cidara’s ability to obtain
additional financing; Cidara’s ability to obtain and maintain
intellectual property protection for its product candidates; and the
loss of key scientific or management personnel. These and other risks
and uncertainties are described more fully in Cidara’s Form 10-K most
recently filed with the United States Securities and Exchange
Commission. All forward-looking statements contained in this press
release speak only as of the date on which they were made. Cidara
undertakes no obligation to update such statements to reflect events
that occur or circumstances that exist after the date on which they were
made.
Contacts
INVESTOR CONTACT:
Robert H. Uhl
Westwicke Partners, LLC
Managing
Director
(858) 356-5932
robert.uhl@westwicke.com
MEDIA CONTACT:
Andrea Cohen
Sam Brown Inc.
(917)
209-7163
andreacohen@sambrown.com