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Antares starts dosing in Phase III QuickShot trial evaluating testosterone-deficient adult males

US-based Antares Pharma has dosed first patient in a Phase III trial designed to evaluate the efficacy and safety of QuickShot Testosterone (QS T) administered subcutaneously once each week to testosterone-deficient adult males.

The company said that patients enrolled in the trial must have a documented diagnosis of hypogonadism, or testosterone deficiency defined as having testosterone levels below 300ng/dL.

About 150 patients will be enrolled in the double-blind, multiple-dose Phase III trial, which will include a screening phase, a treatment titration and efficacy phase and an extended treatment phase.

Antares Pharma president and chief executive officer Eamonn Hobbs said the company is happy to announce that the first patient has been dosed in the Phase III QS T trial of testosterone-deficient adult males.

"The QS T delivery system could potentially fill a patient need for a more precise and convenient dosing regimen in the growing testosterone replacement market," Hobbs said.

"Our proprietary QuickShot system is designed for pain-free subcutaneous administration of a weekly fixed dose of testosterone through a fine gauge needle in a matter of seconds.

"We look forward to working closely with the U.S. Food and Drug Administration to bring this novel product to an expanding market."

During the trial, patients meeting all eligibility criteria will be randomized to receive a starting dose of QS T once weekly for six weeks.

The company said that adjustments to dose may be made at week seven based upon the week six pre-dose blood level.

The efficacy of QS T and dose adjustment to regulate testosterone levels will be assessed after 12 weeks of treatment.

Following completion of this phase, patients may remain on their optimized QS T dose and will be followed for an additional 40 weeks.

Around 100 patients will be needed to complete collection of 26 weeks of safety data, and about 50 patients will be needed to complete collection of 52 weeks of safety data.