Benzinga | Jul 22, 2021 08:36AM EDT

Antares Pharma Announces FDA Acceptance Of IND Application For ATRS-1902 For Adrenal Crisis Rescue

Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug Application (IND) for ATRS-1902 for adrenal crisis rescue. The active IND enables Antares to initiate a Phase 1 clinical study for ATRS-1902 for the treatment of acute adrenal insufficiency, known as adrenal crisis, in adults and adolescents, using a novel proprietary auto-injector platform to deliver hydrocortisone.



"The FDA acceptance of this IND is an important milestone in the development of a novel formulation and delivery of hydrocortisone in a crisis situation. We believe acute adrenal insufficiency is a medical emergency which would benefit from a simplified and readily-available way to administer an essential treatment during a possibly life-threatening situation," commented Dr. Peter Richardson, MRCP (UK), EVP, Research and Development and Chief Medical Officer of Antares Pharma.

Adrenal crisis is a potentially fatal condition associated mainly with an acute deficiency of cortisol, which is a hormone produced and released by the adrenal gland, and commonly occurs in patients with long-term adrenal insufficiency. Current standard of care for the management of acute adrenal crises includes Solu-Cortef(r), which is an anti-inflammatory glucocorticoid. With hydrocortisone sodium succinate as the active ingredient, Solu-Cortef(r) is provided as a sterile powder that needs to be reconstituted for intravenous or intramuscular injection and can represent a potentially time-consuming and cumbersome injection process, particularly challenging in a crisis situation.

Robert F. Apple, President and Chief Executive Officer of Antares Pharma, added, "We are pleased to be able to advance the development of our proprietary pipeline with the FDA acceptance of this IND. With a novel expansion to our device technology platform, we hope to enhance the clinical benefit and offer key advantages to this important patient population at a critical time. We also look forward to the opportunity to leverage the success that our commercial team continues to garner with XYOSTED to ATRS-1902, as both products have an endocrinology call point. We are excited to continue to invest in our proprietary pipeline to support our potential future growth."

The IND application for ATRS-1902 includes a protocol for an initial clinical study to compare the pharmacokinetic (PK) profile of the Company's novel formulation of hydrocortisone versus Solu-Cortef(r), which is expected to initiate in 2H 2021. Assuming this study is completed successfully, a second study will then be conducted utilizing Antares' proprietary auto-injector technology which has been developed to provide reliability and ease-of-use in emergency situations by the patient or caregiver. We believe these two studies will be the basis of our anticipated 505(b)(2) NDA filing with the FDA expected towards the end of 2022.