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news.Ipsen has dropped its phase III study for its investigational four-month formulation of triptorelin after the first part of the trial failed to meet expectations.
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The goal of the trial was to develop a four-month formulation of triptorelin, the active ingredient in Decapeptyl, a treatment for hormone sensitive prostate cancer. Ipsen’s goal remains to have a new formulation of triptorelin available when the current patents of the three-month formulation of Decapeptyl expire, the company said.
Jacques-Pierre Moreau, executive vice-president and chief scientific officer of Ipsen, said: “We are taking all appropriate actions to solve the scale-up issues seen during this phase III, which are inherent to advanced formulations based on cutting edge technologies. From the onset, the introduction of an innovative subcutaneous presentation using a new retro-injection device was well received by patients and investigators.
“Thus, the teams are now focusing their energy and expertise in order to resume phase III as soon as possible. Our advanced drug delivery platform has already been validated through the success of Somatuline Autogel, and we are confident in Ipsen’s ability to have a differentiated formulation of triptorelin.”