ATRS: Ph1 ATRS-1902 for Adrenal Crisis Rescue
Sept 30, 2021 13:14:06 GMT
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Post by icemandios on Sept 30, 2021 13:14:06 GMT
Antares Pharma Initiates Phase I Study For ATRS-1902 For Adrenal Crisis Rescue
Pharmacokinetic data results expected in 1Q 2022
EWING, N.J., Sept. 30, 2021 (GLOBE NEWSWIRE) -- 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 ® (100 mg), the reference-listed drug, in 32 healthy adults.
About Antares Pharma
Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug delivery auto injector technology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia). Antares Pharma’s FDA-approved products include XYOSTED ® (testosterone enanthate) injection, OTREXUP ® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva. The Company also markets NOCDURNA ® (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals.
Pharmacokinetic data results expected in 1Q 2022
EWING, N.J., Sept. 30, 2021 (GLOBE NEWSWIRE) -- 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 ® (100 mg), the reference-listed drug, in 32 healthy adults.
About Antares Pharma
Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug delivery auto injector technology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia). Antares Pharma’s FDA-approved products include XYOSTED ® (testosterone enanthate) injection, OTREXUP ® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva. The Company also markets NOCDURNA ® (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals.
