Post by icemandios on Jan 11, 2022 13:48:31 GMT
Antares Pharma Announces Positive Results From Phase I Study For ATRS-1902 For Adrenal Crisis Rescue
EWING, N.J., Jan. 11, 2022 (GLOBE NEWSWIRE) -- 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™ 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 ® (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.”
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 and Sumatriptan Injection USP, which is distributed by Teva. The Company also markets NOCDURNA ® (desmopressin acetate) in the U.S. and expects to commercially launch TLANDO ® (testosterone undecanoate) in the U.S. pending final FDA approval.
EWING, N.J., Jan. 11, 2022 (GLOBE NEWSWIRE) -- 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™ 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 ® (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.”
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 and Sumatriptan Injection USP, which is distributed by Teva. The Company also markets NOCDURNA ® (desmopressin acetate) in the U.S. and expects to commercially launch TLANDO ® (testosterone undecanoate) in the U.S. pending final FDA approval.