Benzinga | Sep 30, 2021 09:02AM EDT

Antares Pharma Initiates Phase I Study For ATRS-1902 For Adrenal Crisis Rescue

Antares Pharma, Inc. (NASDAQ:ATRS) ("the Company"), a specialty pharmaceutical company, today announced that it has initiated a Phase 1 study for ATRS-1902 for adrenal crisis rescue. The development program supports a proposed indication for the treatment of acute adrenal insufficiency, known as adrenal crisis, in adults and adolescents, using a novel proprietary auto-injector platform to deliver a liquid stable formulation of hydrocortisone.



"We are pleased to be able to dose the first subjects for this study with a liquid stable dosage that eliminates the need for reconstitution. The opportunity to provide an essential treatment that can be easily administered for a potentially life-threatening situation remains a core focus of our research and development efforts. We remain committed to progressing our internal clinical programs to help expand our commercial portfolio," commented Dr. Peter Richardson, MRCP (UK), EVP, Research and Development and Chief Medical Officer of Antares Pharma.

Robert F. Apple, President and Chief Executive Officer of Antares Pharma, added, "The initiation of this study demonstrates our ongoing commitment to helping underserved patients in the area of rescue therapies. Our development team created a new device platform specific to the needs of patients experiencing adrenal crisis. As a leader in rescue pen technology, we hope to be able to provide a simple injection for patients in crisis versus the multiple step process required for the current standard of care. If successful in this Phase 1 study, we expect to then conduct a bioequivalence study and second human factor study that will form the basis of a 505(b)(2) NDA filing with the FDA."

The Phase I study is designed to evaluate the safety, tolerability and pharmacokinetics (PK) of a liquid stable formulation of hydrocortisone. The study is a cross-over design to establish the PK profile of ATRS-1902 (100 mg) compared to Solu-Cortef(r) (100 mg), the reference-listed drug, in 32 healthy adults.