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news.Ipsen has 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.
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In the light of these results, Ipsen announces its intention to file the first ready-to-use liquid toxin A in Europe and in the Rest of the World (ROW).
Ipsen chief scientific officer and Research and Development executive vice-president Claude Bertrand noted with these studies, the company confirms its role of pioneer in the field of toxins and its 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," Bertrand added.
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.
DNG was clinically and statistically superior to placebo and comparable to Dysport in the glabellar lines Phase II study at the dose of 50 units after single dose.
Across the studies, DNG showed safety profiles 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.