CalciMedica Inc. announced that there will be a presentation of data from the initial cohort of the CRSPA study of Auxora(TM) (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(TM) 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(TM) 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 XIV 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(TM) and RYLAYZE(TM), a nearly identical ALL treatment protocol as used in the CRSPA study.

The results showed that treatment with Auxora(TM) 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. 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).