Antares Pharma Inc. (NASDAQ: ATRS) has announced an Investigational New Drug Application to the FDA to commence its Phase 1 ATRS-1902 clinical study to treat adrenal crisis rescue.
Adrenal crisis is associated with cortisol deficiency
The ATRS-1902 application and corresponding development program support proposed acute adrenal insufficiency (adrenal crisis) treatment using a new proprietary auto-injector delivery platform for hydrocortisone.
Dr. Peter Richardson, Antares Pharma EVP R&D, and Chief Medical Officer said that adrenal crisis is a fatal condition often associated with acute cortisol deficiency. Cortisol is a hormone released by the adrenal gland, and deficiency often occurs in patients struggling with long-term adrenal insufficiency. Richardson said that Addison’s disease or primary adrenal insufficiency affects around 10 and 140 people in every one million people.
Currently, Solu-Cortef®, an anti-inflammatory glucocorticoid, is the standard of care for treating acute adrenal crises. Solu-Cortef® contains hydrocortisone sodium succinate as the active ingredient and is delivered as a sterile powder that must be reconstituted for intramuscular or intravenous injection.
ATRS-1902 could offer treatment for adrenal crisis patients
Antares Pharma CEO Robert F. Apple said, “This IND submission represents a key milestone for Antares as we continue to advance our proprietary pipeline. With a novel expansion to our device technology platforms, we believe ATRS-1902 could potentially offer a better solution for patients in need of rescue therapy compared to current standard of care. Positive results from an initial user study and payer survey further highlight the key advantages and opportunity for this rescue therapy. We look forward to providing more detail on the timeline and market opportunity following FDA acceptance of the IND.”
With the FDA feedback during a Pre-IND meeting, the IND application includes a protocol for commencement of clinical study to evaluate the pharmacokinetic profile of Solu-Cortef.