Benzinga | Jan 11, 2022 07:34AM EST

Antares Pharma Announces Results From Phase I Study For ATRS-1902 For Adrenal Crisis Rescue; Co. Reports 'The results of the Phase I cross-over study met its primary objective showing ATRS-1902 delivered a comparable pharmacokinetic profile to Solu-Cortef'

Antares Pharma, Inc. (NASDAQ:ATRS) (the "Company"), a specialty pharmaceutical company, today announced positive results from a Phase I study for ATRS-1902 for adrenal crisis. The positive results support the advancement of the ATRS-1902 development program to a pivotal clinical study for the treatment of acute adrenal insufficiency, known as adrenal crisis, in adults and adolescents, using our Vai(tm) novel proprietary rescue pen platform to deliver a liquid stable formulation of hydrocortisone.

The results of the Phase I cross-over study met its primary objective showing ATRS-1902 (100 mg) delivered a comparable pharmacokinetic profile to Solu-Cortef(r) (100 mg), the reference-listed drug, in 32 healthy adults. The study also demonstrated that ATRS-1902 was safe and well tolerated.

"We are pleased that the results from this Phase I study support the advancement of ATRS-1902 to a pivotal clinical study which we anticipate starting in the second quarter of 2022. As we remain focused on strengthening our clinical development pipeline, we expect to file the 505(b)(2) NDA with the FDA by the end of 2022 assuming the successful completion of the pivotal study and an additional human factor study. We look forward to the opportunity to provide an essential treatment that can be easily administered for a potentially life-threatening situation," 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, "These positive results reinforce our commitment to improving the current standard of care for adrenal crisis patients and advancing our proprietary development pipeline. As a leader in rescue pen technology, our recently developed Vai device allows for a simple injection for patients in crisis. With a clear development timeline, we expect ATRS-1902 to support our future revenue growth and leverage our commercial organization and one of our current therapeutic footprints in endocrinology."