Dr. Ken Stauderman and collaborators discovered the role of STIM1, in conjunction with Orai1, in forming CRAC channels targeted by CalciMedica’s drug compounds.
CalciMedica was founded by scientists from TorreyPines Therapeutics, including Dr. Stauderman, CalciMedica’s Co-founder and Chief Scientific Officer, and a team from Harvard’s CBR Institute for Biomedical Research comprised of Drs. Anjana Rao, Patrick Hogan (both currently at the La Jolla Institute for Immunology) and Stefan Feske (currently at NYU School of Medicine).
At CalciMedica, Dr. Stauderman and a team of skilled scientists developed a series of proprietary assays that led to the identification and optimization of a portfolio of potent and highly selective CRAC channel inhibitors.
CalciMedica advanced the first CRAC channel inhibitor into human clinical studies. This compound demonstrated safety and trends towards efficacy as an orally administered agent in patients with moderate to severe plaque psoriasis.
Different CalciMedica CRAC channel compounds were developed with improved potency and selectivity; CM4620 (the intravenous (IV) formulation of which was named AuxoraTM) was selected for development.
AuxoraTM entered into clinical development, proceeding through Phase 1 studies in healthy volunteers and several Phase 2 studies in patients with acute pancreatitis and accompanying systemic inflammatory response syndrome (SIRS) as well as severe and critical COVID-19 pneumonia, again demonstrating safety and efficacy.
In conjunction with St Jude Children’s Research Hospital, an Investigator-Initiated Clinical Trial was launched in pediatric cancer patients with acute lymphocytic leukemia (ALL) that develop acute pancreatitis in response to a specific chemotherapeutic agent used to treat ALL.
Several promising oral CRAC channel inhibitor drug candidates are in preclinical development to address chronic inflammatory conditions. We expect to submit an IND in 2024.
The clinical profile for AuxoraTM suggests broad application in different acute inflammatory diseases in critically ill patients, potentially including acute respiratory distress syndrome (ARDS) and acute kidney injury (AKI).