Antares Pharma is stepping up its pursuit of Pfizer. Having taken a rescue pen rival to Pfizer’s Solu-Cortef through a phase 1 study, Antares is preparing for a pivotal clinical trial designed to support a filing for FDA approval by the end of the year.
New Jersey-based Antares is partnered with Pfizer on another rescue pen candidate but is a potential competitor to the Big Pharma company in the adrenal crisis space. Today, patients who need to quickly increase their cortisol levels to stop adrenal crisis, a condition associated with low blood pressure, use Pfizer’s Solu-Cortef.
The administration of Solu-Cortef is a multistep process that entails mixing a powder in a vial, extracting the resulting solution using a syringe and injecting it into the thigh. Antares wants to simplify the process by providing a liquid-stable formulation of hydrocortisone in a rescue pen delivery device, leading it to start a phase 1 clinical trial of its ATRS-1902 candidate last year.
Initial findings from the study are now available. Antares is yet to share results from the 32-subject study of healthy adults, but, with the trial showing the candidate has a comparable pharmacokinetic profile to Solu-Cortef, it is moving forward with further development.
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“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,” Antares CEO Robert Apple said in a statement.
Antares plans to start a pivotal study of ATRS-1902 in the second quarter and is also working on another human factor study. As the candidate is based on an approved molecule, the company expects to be able to leverage existing data and file for FDA authorization via the 505(b)(2) pathway by the end of the year.