Our Technologies and Pipeline:

Targeting CRAC
Channel Inhibition for
Inflammatory Diseases
of High Unmet Need

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 diseases for which there are currently no approved therapies

The Role of CRAC Channels in the Immune System

1) Activation of CRAC channels is a key step in initiating an immune response.

2) CRAC channels regulate the amount of calcium entering the cell across the cell membrane.

3) In T cells, for example, stimulation of the T cell receptor opens CRAC channels, resulting in the expression and release of inflammatory signals like cytokines, driving the adaptive immune response.

4) CRAC channels also play a key role in the activation of other inflammatory cells of the immune system.

Over-activation of CRAC Channels in Organ Tissue Cells

1) Organ tissue cells, e.g. pancreatic acinar and ductal cells, contain CRAC channels that can be activated in non-physiological ways by various means – toxins, trauma and infection.

2) This can lead to overactivation of CRAC channels.

3) When this happens, excess calcium can enter the cells.

4) High intracellular calcium levels can cause tissue cell damage and death.

CRAC Channel Inhibition

1) Inhibiting CRAC channels with Auxora is beneficial in two ways – it reduces immune cell activation and the accompanying inflammation driven by the immune response.

2) And it protects non-immune cells from damage or death by blocking excess calcium from entering those cells.

The Role of CRAC Channels in the Immune System

1) Activation of CRAC channels is a key step in initiating an immune response.

2) CRAC channels regulate the amount of calcium entering the cell across the cell membrane.

The Role of CRAC Channels in the Immune System

3) In T cells, for example, stimulation of the T cell receptor opens CRAC channels, resulting in the expression and release of inflammatory signals like cytokines, driving the adaptive immune response.

4) CRAC channels also play a key role in the activation of other inflammatory cells of the immune system.

Over-activation of CRAC Channels in Organ Tissue Cells

1) Organ tissue cells, for example, pancreatic acinar or ductal cells, contain CRAC channels that can be activated in non-physiological ways by various means – toxins, trauma or infection – which can lead to

2) overactivation of CRAC channels.

3) When this happens, excess calcium can enter the cells and cause

Over-activation of CRAC Channels in Organ Tissue Cells

4) tissue cell damage and death.

CRAC Channel Inhibition

1) Inhibiting CRAC channels with Auxora is beneficial in two ways – it reduces immune cell activation and the accompanying inflammation driven by the immune response.

2) And it protects non-immune cells from damage or death by blocking excess calcium from entering those cells.

Our Lead Candidate

Auxora™’s Dual Mode of Action: As a CRAC Channel Inhibitor, Auxora™ Modulates the Immune Response and Protects Against Tissue Cell Injury

Preclinical and clinical data have demonstrated that the inhibition of CRAC channels may have a therapeutic effect based on a dual mechanism involving both anti-inflammatory and tissue cell protective activities.

CalciMedica is developing Auxora™ as a potential disease-modifying therapy for patients with life-threatening inflammatory diseases of the pancreas, kidney and lung, for which there are currently no approved therapies.

Immune Cells:
Modulates Immune Response

In immune cells, activation of CRAC channels is a key step in initiating the adaptive immune response and the generation of inflammatory signals such as cytokines. Inhibiting CRAC channels with Auxora™ may reduce immune cell activation and the accompanying inflammation driven by the immune response.

Non-Immune Cells:
Blocks Calcium from Entering the Cells

CRAC channels on affected organ tissue cells can become inappropriately activated or overactivated, resulting in excess calcium entry into cells. This excess calcium can cause cellular injury and necrosis or activate apoptosis signaling pathways leading to programmed cell death, which is further exacerbated by the damage caused by the inflammatory response. Inhibiting CRAC channels with Auxora™ may reduce organ damage by blocking excess calcium.

About CalciMedica

“Since the inception of CalciMedica more than 15 years ago, we have advanced our research of CRAC channel inhibitors and their role in acute and chronic inflammatory illnesses. We believe the potential for Auxora, our proprietary intravenous-formulated CRAC channel inhibitor, to treat life-threatening inflammatory diseases by modulating the immune response and reducing organ cell damage, is significant.”

Ken Stauderman,
Chief Scientific Officer and co-founder of CalciMedica

CalciMedica’s lead pipeline candidate, Auxora™, is a proprietary, intravenous-formulated, small molecule CRAC channel inhibitor. Auxora™ has been studied in four Phase 2 clinical trials, demonstrating positive and consistent clinical results as well as a favorable safety profile, and is currently being studied in two additional Phase 2 clinical studies.

Auxora™ has been studied in four completed Phase 2 trials, demonstrating positive and consistent clinical results and a favorable safety profile.
View the Trial Results
Our Pipeline
Program1 Indication Phase of Development Anticipated Milestones
Preclinical Phase 1 Phase 2 Phase 3
Acute Disease (IV)
Auxora Acute Pancreatitis
CARPO Phase 2b trial positive topline data released
Final data expected in 2H2024
Auxora Asparaginase-Induced Pancreatic Toxicity in Pediatric Patients
CRSPA Phase 1/2 trial ongoing
Data expected in 2025
Auxora Acute Kidney Injury
KOURAGE Phase 2 trial ongoing
Data expected in 2025
Chronic Disease (Oral)
CM6336 Chronic Pancreatitis
Potential IND submission in 2025
CM6336 Rheumatoid Arthritis
Potential IND submission in 2025

1 All Auxora programs are IV for rapid onset in the acute care setting; CM6336 is intended for chronic oral dosing

Acute Disease (IV)
Chronic Disease (Oral)

1 All Auxora programs are IV for rapid onset in the acute care setting; CM6336 is intended for chronic oral dosing

Targeted Indications
Acute Pancreatitis With Accompanying Systemic Inflammatory Response Syndrome (SIRS)
300
K

Hospitalizations per year in the US, with one third having or developing SIRS, indicative of predicted or severe disease 

  • Standard of care: Supportive care – IV fluids, pain medication, and nutrition
  • Severe complications include pancreatic necrosis, life-threatening distal organ failure, and acute respiratory distress syndrome (ARDS)
  • 20-30% mortality rate in patients with severe disease
Learn More
Asparaginase-Induced Pancreatic Toxicity (AIPT) / Asparaginase-Associated Pancreatitis (AAP)
3,000

Children with acute lymphoblastic leukemia (ALL) treated with chemotherapeutic asparaginase in US annually, 7-10% of whom develop AIPT

  • Standard of care: Supportive care – IV fluids, pain medication, and nutrition
  • >50% of pediatric AIPT patients develop pancreatic necrosis and/or pancreatic pseudocysts 
  • AIPT requires that asparaginase treatment be halted beyond this there can be other short- or long-term consequences
Learn More
Stage 2 or 3 (moderate or severe) Acute Kidney Injury (AKI)
1.1
MM

30% of 3.7MM patients hospitalized annually in the US with AKI are Stage 2 and Stage 3

  • Standard of Care: Supportive care Treatment of complications; dialysis
  • Disease can progress to:
    • Chronic kidney disease
    • End stage renal disease
    • Eventual Death
Learn More
Acute Respiratory Distress Syndrome (ARDS)
200
K

Patients per year in the U.S.
3M Patients per year globally

  • Standard of care: Oxygen and fluid management; invasive mechanical ventilation
  • 10% of intensive care unit admissions worldwide each year. 75-80% moderate or severe. Life-threatening complications including organ damage or organ failure
  • 30-40% mortality rate. Leads to 75,000 deaths annually in the U.S
Learn More
Our Technologies

CalciMedica’s Proprietary Technology Targeting CRAC Channel Inhibition for the Treatment of Inflammatory Diseases of High Unmet Need

About CalciMedica

“In the U.S. alone, nearly 300,000 people are admitted to the Emergency Room each year suffering from acute pancreatitis, one of several life-threatening inflammatory illnesses for which doctors have very little to offer aside from supportive care. In our Phase 2 clinical trials, we demonstrated that patients treated with our lead compound, Auxora™, benefited from improved outcomes, including the ability to tolerate solid food sooner, with earlier discharge from the hospital and fewer follow-on complications. We are encouraged by these findings as we continue our quest to improve the lives of patients with acute inflammatory illnesses.”

Sudarshan Hebbar, M.D.,
Chief Medical Officer

We have studied Auxora™ in multiple clinical trials including four Phase 2 clinical trials, two of which were in our lead indication, acute pancreatitis (AP) with accompanying systemic inflammatory response syndrome (SIRS).

We believe the consistency of the clinical results we observed from these four trials in multiple acute critical care conditions affecting different primary organs are mutually supportive and reinforce our plans to further pursue the use of Auxora in additional acute critical illnesses, such as acute kidney injury (AKI).