Eagle Pharmaceuticals, a New Jersey-based pharmaceutical company, said that its product Ryanodex (dantrolene sodium) for injectable suspension inhibited the growth of SARS-CoV-2, the virus causing the COVID-19 pandemic, in a controlled in vitro laboratory test. On Tuesday, April 14, Eagle submitted its Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a Phase 2 clinical trial in partnership with Hackensack University Medical Center to evaluate the efficacy of Ryanodex in patients infected with SARS-CoV-2. Eagle has been in contact with the FDA’s Coronavirus Treatment Acceleration Program (CTAP) to request potential expedited review of the IND application and aims to begin the clinical trial as soon as possible.
 
 
Eagle is working to increase production of Ryanodex in advance of clinical results and to potentially shorten the supply chain lead time if necessary. To that end, Eagle is forming a manufacturing partnership with another NJ-based pharma firm, Amneal Pharmaceuticals. Eagle is also working with its existing manufacturing partner, Durham, NC-based Alcami, a provider of contract manufacturing services for pharmaceutical and biotechnology clients around the globe to increase its production.
 
Ryanodex is approved by the FDA for the treatment of patients with malignant hyperthermia (MH) in conjunction with appropriate supportive measures, and for the prevention of MH in patients at high risk. MH is a life-threatening condition experienced by susceptible individuals exposed to certain medications. MH is characterized by high body temperature, muscle hyperactivity, rapid heart rate and other symptoms.
 
Ryanodex acts by modulating free intracellular calcium levels to restore calcium homeostatic balance inside cells. Eagle has worked for many years to understand how Ryanodex impacts calcium regulation in cells. This work has served as the basis for Eagle to study a number of different diseases and disorders in which intracellular calcium dysregulation may be an important factor.
 
Eagle is now exploring the relationship between viral infection and the regulation of calcium levels inside cells. Viruses can exploit host cells to replicate by creating dysfunction in the intracellular environment. Depending on the virus type, an altered intracellular calcium balance may enhance virus entry, replication and release. As a result, intracellular calcium levels may be an important factor in viral-host interactions and viral infections. Dysregulation of the intracellular calcium homeostasis may benefit the virus lifecycle leading to cell death and worsening of the disease.
 
“The results of Eagle Pharmaceuticals’ virus neutralization assay demonstrated a lack of viral growth in Ryanodex -treated cells compared to those not treated with Ryanodex. This outcome suggests that Ryanodex may have antiviral activity against SARS-CoV-2, which we believe represents a novel approach to impeding the virus lifecycle by modulating free intracellular calcium levels of host cells,” said Adrian Hepner, chief medical officer, Eagle Pharmaceuticals. “We now plan to conduct a clinical trial in partnership with Hackensack University Medical Center to evaluate the efficacy and safety of Ryanodex as a potential treatment for patients hospitalized with COVID-19.”