CalciMedica’s lead product candidate is AuxoraTM, a potent and selective intravenous (IV) formulated small molecule CRAC channel inhibitor containing the active compound zegocractin (formerly referred to as CM4620) that, in animal models, reduced acute epithelial and/or endothelial cell injury and inflammation in organs, such as the pancreas, lungs and kidneys. Evidence suggests that CRAC channels play a role in inflammation-induced injury of pulmonary endothelial cells, resulting in loss of alveolar-capillary barrier function and accumulation of fluid in the alveoli. Similarly, hyperactivation of CRAC channels results in excessive calcium influx into pancreatic acinar and ductal cells, which can lead to cell dysfunction and death and plays a pivotal role in cellular injury and the progression of acute pancreatitis. In each of these settings, local and systemic inflammation can exacerbate the problem, leading to organ failure and death.
We have conducted three Phase 2 clinical trials with Auxora: an open-label trial in acute pancreatitis (AP), a placebo controlled double-blind trial in COVID-19 pneumonia (which we also refer to as CARDEA) and an open-label trial in the same indication. We observed in all three trials that patients treated with Auxora experienced a reduced time to recovery and less respiratory failure and, in CARDEA, we observed a numerical improvement of 56% relative risk reduction in mortality at 30 days. We believe the consistency of the results we observed from these three trials in two different acute critical care conditions are mutually supportive and reinforce our plans to further pursue the use of Auxora in several additional acute critical illnesses.