Ipsen Presents the Results of the First in-Human Study of a Recombinant Fast-Acting Neurotoxin (rBoNT-E) at TOXINS 2019

Regulatory News:

Results of the first in-human study of a recombinant neurotoxin are being presented at the TOXINS International Conference in Copenhagen. Ipsen’s recombinant BoNT serotype E (rBoNT-E) was investigated in a phase I study that demonstrated its safety and tolerability profile in healthy volunteers¹. The study also reported that it has a faster onset of action and a shorter duration of effect, as well as a quick time to peak activity, in comparison with established BoNT-A products. Further studies will be initiated to establish potential aesthetic and therapeutic uses of this investigational therapy.

“The application of recombinant techniques to create novel botulinum toxin-based medicines with different onsets and durations of action, will potentially offer clinicians the flexibility to choose the most appropriate neurotoxin for each patient, which is not an option today,” said Philippe Picaut, Pharm. D., PhD, Senior Vice President Research & Development for the Neuroscience Therapeutic Area, Ipsen.

Botulinum neurotoxins (BoNTs) are naturally occurring proteins (produced by Clostridium bacteria) that were first discovered in the 19^th century. They are classified into seven serotypes (A-G) with the majority of commercialized BoNT products being serotype A. BoNTs are used in multiple different conditions after injection in skeletal muscles (eg cervical dystonia, hemifascial spasm, blepharospasm, spasticity in adult and children; aesthetic); smooth muscles (neurogenic detrusor overactivity, idiopathic bladder overactivity) or exocrine gland hyperfunction (eg sialorrhea, axillary hyperhidrosis).

Alexandre Lebeaut, M.D., Executive Vice President, Research & Development and Chief Scientific Officer, Ipsen stated: “Neurotoxin research is advancing at an unprecedented rate and we, at Ipsen, are at the forefront of this transformation, developing innovative therapeutic and aesthetic solutions that help patients take back control of their lives”.

Ipsen will have 50 posters at Toxins 2019 in Copenhagen, including:

• Outcomes of the first-in-human study with a recombinant botulinum toxin E (rBoNT-E): safety and pharmacodynamic profile of rBoNT-E compared with abobotulinumtoxinA (Dysport); Pons et al.
• New modified recombinant botulinum neurotoxin type F with enhanced potency; Burgina et al.

About the study¹