Ipsen Announces Clinical Results of Dysport Next Generation

02/05/2014

Ipsen announced the results of the international Phase III clinical trial of Dysport Next Generation (DNG) in cervical dystonia and the results of the European Phase II clinical trial of DNG in glabellar lines. In the light of these results, Ipsen also announced its intention to file the first ready-to-use liquid toxin A in Europe and in the rest of the world (ROW).

“This is the very first international Phase III trial to show that a liquid toxin A is safe and efficacious. Although the statistical non-inferiority criterion between DNG and Dysport was not formally met in the double blind phase of the trial, this is unlikely to reflect clinical meaningful differences between the two formulations. In addition, the open label long term data show sustained and robust efficacy of DNG with a good safety profile,” said Pr. Werner Poewe (International Principal Investigator of the study) in a release from the company. “These important results will help the medical community to assess the place of a ready-to-use liquid toxin A in the treatment options for patients suffering from cervical dystonia.”

Claude Bertrand, Executive Vice-President Research & Development and Chief Scientific Officer of Ipsen commented: “With these studies, we confirm our role of pioneer in the field of toxins and our leadership in developing innovative therapeutic solutions. Ipsen's ambition is to become the first company to file a ready-to-use liquid toxin A, which should meet the expectations of physicians by potentially providing a new treatment option for patients.”

DNG was clinically and statistically superior to placebo in the cervical dystonia Phase III study at the dose of 500 units at week four after single dose (adjusted mean reduction of 12.5 with DNG versus 3.9 with placebo as assessed by the Toronto Western Spasmodic Torticollis Rating Scale, or TWSTRS, total score). When compared to Dysport, DNG did not demonstrate the statistical non-inferiority in efficacy at week four (adjusted mean reduction of 12.5 with DNG versus 14.0 with Dysport in TWSTRS total score). This efficacy difference is unlikely to be of clinical relevance. After repeated dose, DNG showed comparable efficacy to that of Dysport as observed in former Phase III studies.

The double-blind, randomized, placebo and active comparator controlled Phase II trial in glabellar lines included 176 patients. The primary endpoint of the study was the assessment of DNG efficacy and safety, as compared to placebo and Dysport, in the treatment of patients with moderate to severe glabellar lines. DNG was clinically and statistically superior to placebo and comparable to Dysport at the dose of 50 units after a single dose at week four, as assessed by a co-primary endpoint composed of the “investigator live assessment” and “the subject self-assessment.” Based upon “the investigator live assessment”, the responder rate was 91 percent for DNG and 77 percent for Dysport, respectively. Based upon the “patient self-assessment,” the responder rate was 86 percent for DNG and 83 percent for Dysport, respectively. The responder rate corresponds to the number of patients who had an improvement of their wrinkles from “severe/moderate wrinkles” to “mild/no wrinkle” on any scale.

The safety profile observed of DNG after unique and repeated dose was excellent and consistent with the known safety profile of Dysport.

Regarding DNG stability, analysis is still ongoing. The stability data trends are positive, providing confidence of achieving a commercially viable product. Ipsen is continuing stability testing to establish maximum shelf life across full product range.

On the basis of these results and feedback from the Principal Investigator of the Phase III study, Ipsen intends to initiate a dialog with key agencies on the regulatory approach to file the first ready-to-use liquid toxin A in Europe and ROW.

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