Auxora™ showed a 53%
reduction in days in hospital, a 40% reduction in intensive care
unit (ICU) days and eliminated the need for total parenteral
nutrition (TPN)
LA
JOLLA, Calif., Nov. 2, 2023
/PRNewswire/ -- CalciMedica Inc. ("CalciMedica") (Nasdaq: CALC), a
clinical-stage biopharmaceutical company focused on developing
novel calcium release-activated calcium (CRAC) channel inhibition
therapies for acute and chronic inflammatory and immunologic
diseases, today announced that there will be a presentation of data
from the initial cohort of the CRSPA study of Auxora™ (zegocractin)
in asparaginase-induced pancreatic toxicity (AIPT) in a poster
presentation at the 65th Annual American Society of Hematology
(ASH) Meeting & Exposition being held December 9-12, 2023 in San Diego, CA.
The data to be presented by the study sponsor highlights
promising early results of the investigational use of Auxora™ in
children with acute lymphoblastic leukemia (ALL) experiencing
asparaginase-associated pancreatitis, also known as AIPT and
referred to as AAP in the abstract. The presentation includes
results from the first cohort consisting of nine patients from the
CRSPA study. Eight of nine patients received a full regimen of 4
daily doses of Auxora™ and results from these patients are compared
to a historical matched control group of 16 patients with complete
imaging out of a total of 51 patients who developed pancreatitis in
the Total Therapy XVI study (T16). These children were treated at
St. Jude Children's Research Hospital ("SJCRH") and developed
pancreatitis within 30 days of receiving asparaginase (e.g.
ONCASPAR™ and RYLAYZE™), a nearly identical ALL treatment protocol
as used in the CRSPA study.
The results showed that treatment with Auxora™ compared to the
historical matched control group reduced the average number of days
patients spent in the hospital from 13.4 to 6.3 days. Three control
patients (18.8%) needed intensive care unit (ICU) care compared to
one treated patient (12.5%), and the average number of days in the
ICU was reduced from 5 to 3 days. Additionally, no CRSPA patients
required total parenteral nutrition (TPN), compared to 68.8% in the
historical matched control group. The matched control patients that
required TPN needed 27 days of nutritional support on average.
Based on the results from cohort 1 of CRSPA, a dose level 1
(30mg/m2 on day 1 and 42mg/m2 on days 2-4)
has been established as the recommended dose (RP2D) of Auxora™ for
children with ALL experiencing AIPT.
Presentation Title: Zegocractin to Reduce the Severity of
Asparaginase Associated Pancreatitis in Children with Acute
Lymphoblastic Leukemia: Results of the Phase 1 Portion of the CRSPA
Study
Presenter: Seth Karol,
M.D., St. Jude Children's Research Hospital
Session Date and Time: Sunday, December 10, 2023,
from 6:00 p.m. – 8:00 p.m. PT
Session Title: 612. Acute Lymphoblastic Leukemias:
Clinical and Epidemiological: Poster II
Publication #: 2837
About AIPT and CRSPA
AIPT is an ultra-orphan
indication affecting 300-400 patients in the US each year. One of
the mainstays of therapy in pediatric ALL patients is asparaginase
(e.g. ONCASPAR™ and RYLAYZE™), an enzyme that degrades the amino
acid asparagine, which is essential for the leukemic cells to
survive. However, the administration of asparaginase triggers the
development of AAP or AIPT in 7-10% of patients, including the over
4,000 pediatric ALL patients treated per year in the United States, with similar numbers in
Europe. The first cohort in the
dose-finding part of the CRSPA study consisting of 9 patients has
been completed at SJCRH and investigators believe that an optimal
pediatric dose for Auxora™ in this setting has been defined. The
study has continued to enroll patients beyond the initial 9 patient
cohort and is being expanded to additional sites. The full study
plans for 24 patients at the optimal dose. Details of the CRSPA
study are available on clinicaltrials.gov (NCT04195347).
About CalciMedica
CalciMedica is a clinical-stage
biopharmaceutical company focused on developing novel CRAC channel
inhibition therapies for inflammatory and immunologic diseases.
CalciMedica's proprietary technology targets the inhibition of CRAC
channels to modulate the immune response and protect against tissue
cell injury, with the potential to provide therapeutic benefits in
life-threatening inflammatory and immunologic diseases for which
there are currently no approved therapies. CalciMedica's lead
product candidate Auxora™, a proprietary, intravenous-formulated
CRAC channel inhibitor, has demonstrated positive and consistent
clinical results in multiple completed efficacy clinical trials.
CalciMedica is currently conducting a Phase 2b trial in 216 patients called CARPO for acute
pancreatitis (AP) with systemic inflammatory response syndrome
(SIRS), with topline data expected in the first half of 2024.
Additional data from the Phase 1/2 CRSPA AIPT study is expected by
2H 2024. A Phase 2 study in acute kidney injury (AKI) is planned
for early 2024. CalciMedica was founded by scientists from Torrey
Pines Therapeutics and the Harvard CBR Institute for Biomedical
Research, and is headquartered in La
Jolla, CA. For more information, please visit
www.calcimedica.com.
Forward-Looking Statements
This communication contains
forward-looking statements which include, but are not limited to,
statements regarding CalciMedica's preliminary analysis, assessment
and conclusions of the results of the first cohort of the CRSPA
study; the design and potential benefits of Auxora; CalciMedica's
plans and expected timing for developing its product candidates and
potential benefits of its product candidates; CalciMedica's ongoing
and planned clinical trials; the development and outcomes of CARPO
and CRSPA trial programs, including the milestones, data
announcements, expected enrollment and any other potential results
related thereto. These forward-looking statements are subject to
the safe harbor provisions under the Private Securities Litigation
Reform Act of 1995. CalciMedica's expectations and beliefs
regarding these matters may not materialize. Actual outcomes and
results may differ materially from those contemplated by these
forward-looking statements as a result of uncertainties, risks, and
changes in circumstances, including but not limited to risks and
uncertainties related to: the impact of fluctuations in global
financial markets on CalciMedica's business and the actions it may
take in response thereto; CalciMedica's ability to execute its
plans and strategies; the ability to obtain and maintain regulatory
approval for Auxora; results from clinical trials may not be
indicative of results that may be observed in the future; potential
safety and other complications from Auxora; the scope progress and
expansion of developing and commercializing Auxora; the size and
growth of the market therefor and the rate and degree of market
acceptance thereof; economic, business, competitive, and/or
regulatory factors affecting the business of CalciMedica generally;
CalciMedica's ability to protect its intellectual property
position; and the impact of government laws and regulations.
Additional risks and uncertainties that could cause actual outcomes
and results to differ materially from those contemplated by the
forward-looking statements are included under the caption "Risk
Factors" in CalciMedica's Quarterly Report on Form 10-Q for the
quarter ended June 30, 2023 and
elsewhere in CalciMedica's subsequent reports on Form 10-K, Form
10-Q or Form 8-K filed with the SEC from time to time and available
at www.sec.gov. These documents can be accessed on CalciMedica's
web page at ir.calcimedica.com/financials-filings/sec-filings.
CalciMedica Contact:
Investors and Media
Argot Partners
Sarah Sutton/Kevin Murphy
calcimedica@argotpartners.com
(212) 600-1902
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SOURCE CalciMedica