Receive our newsletter – data, insights and analysis delivered to you
  1. News
September 23, 2019updated 29 Oct 2021 9:17am

Ipsen reports positive data for Dysport to treat limb spasticity

Ipsen has reported positive data from the ENGAGE clinical trial of Dysport (abobotulinumtoxinA) in adults with upper and lower limb spastic hemiparesis.

Ipsen has reported positive data from the ENGAGE clinical trial of Dysport (abobotulinumtoxinA) in adults with upper and lower limb spastic hemiparesis.

In the study, the drug candidate was given concurrently with a personalised diary-based rehabilitation programme called guided self-rehabilitation contract (GSC).

Spasticity is characterised by the continuous contraction of some muscles, leading to stiffness or tightness that may impact movement, speech and gait.

Dysport is an injectable formulation of botulinum neurotoxin type A, which is obtained from Clostridium bacteria and blocks the transmission of nerve impulses. This helps to decreases muscular contractions.

The international, prospective, single-arm Phase IIIb/IV ENGAGE study evaluated the effect of Dysport on voluntary movements of the upper and lower limb in 160 patients.

Patients were given 1,500U aboBoNT-A dose during each injection cycle, along with personalised GSC.

Content from our partners
Why this global life sciences COO believes relocation to Charleston, SC, was key to achieving next-level success
Patient-centric pharma logistics: How CRYOPDP delivers hope worldwide
Why Asia-Pacific is the next frontier for decentralized clinical trials

The primary efficacy endpoint of the study was the proportion of patients responding at week 6 following the second injection, based on the composite active range of motion (CXA) in the primary treatment target (PTT) limb.

According to the trial results, 72.1% of the participants experienced a CXA improvement threshold in the PTT limb of ≥35° in upper limbs or ≥5° in the lower limbs.

Ipsen added that the results were supported by the time to reinjection, where the mean time and median time to reinjection were 110.1 days and 106.5 days, respectively.

The time to reinjection in the study was longer than prior upper and lower limb studies that did not include GSC. The safety profile was also consistent with the known abobotulinumtoxinA profile.

Ipsen R&D Neurosciences medical affairs vice-president Antony Fulford-Smith said: “Through ENGAGE, we have been able to demonstrate for the first time the benefit of combining treatment with Dysport with a systematic rehabilitation protocol, validating the positive impact of encouraging patients to take an active role in their own treatment.”

The trial was conducted in the US, Czech Republic, France and Russia.

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU