Ipsen:phase 3 Clinical Study Of Dysport Upper Limb Spasticity Treatment Positive

(RTTNews) - Ipsen (IPSEY) announced that a first set of results on phase III clinical study of Dysport in the treatment of adults suffering from Upper Limb Spasticity was presented at the 8th World Congress for NeuroRehabilitation in Istanbul.

The Phase III clinical study results showed that patients treated with Dysport showed a statistically significantly higher proportion of responders in muscle tone improvement versus placebo. At week 4, patients treated with Dysport 500 units and 1000 units showed responding rates of 73.8% and 78.5%, respectively, compared to 22.8% in the placebo arm. Patients treated with Dysport demonstrated a statistically significant higher clinical benefit versus placebo, as measured by the Physician Global Assessment. At week 4, the mean PGA score for patients treated with Dysport 500 units and 1000 units were 1.4 and 1.8, respectively, compared to 0.6 in the placebo arm.

Additionally, adults treated with Dysport showed a higher proportion of responders from baseline in improved passive function versus placebo. At week 4, patients treated with Dysport 1000 units showed a statistically significant response rate of 62% and Patients treated with Dysport 500 units showed a clinically relevant response rate of 50%. Placebo arm showed a 39% response rate.

The safety profile observed in the study was consistent with the known safety profile of Dysport, according to Ipsen. The phase III research study included 243 patients and was multicentric, prospective, double blind, randomised, and placebo-controlled. It was conducted in the USA, France, Italy, Belgium, Czech Republic, Poland, Slovakia, Russia and Hungary.

Dysport, which is supplied as a lyophilized powder, is an injectable form of botulinum toxin type A, which is isolated and purified from Clostridium BoNT-A bacteria.

On Friday, IPSEN shares closed at $9.99.