Data suggests that an “extra-strength” formulation of the neurotoxin could extend the duration to 26 weeks.
Evolus, Inc. has announced the interim results of its Phase II clinical study evaluating an “extra-strength” formulation for extended duration of Jeuveau® (prabotulinumtoxinA-xvfs), its flagship neurotoxin product.
The interim data was presented at the 2023 International Master Course on Aging Science (IMCAS) World Congress in Paris.
In the Phase II trials, the “extra-strength” formulation of Jeuveau® at 40U (units) achieved a duration profile of 6 months or 26 weeks across the three metrics presented.
That included: the time it takes for patients to return to their baseline Glabellar Line Scale (GLS) score after their treatment; time back to baseline for patients with a response of none or mild on the GLS; and the duration of effect of at least a one-point GLS improvement.
An interim analysis was also performed to assess the safety and efficacy of the “extra-strength” formulation. The adverse events profile across all three arms was similar. The severity rating demonstrated that 88% of the events were mild and 12% were moderate. No serious adverse events were reported.
The extra-strength glabellar line study is a multi-centre, double-blind, randomised Phase II trial. It is following 150 patients at five study sites, for up to 12 months or until the patient loses their correction. The study has three arms: Jeuveau® Extra-Strength 40U and two active controls: the currently approved 20 units of Jeuveau® and 20 units of BOTOX® Cosmetic.
In addition to evaluating the safety, efficacy and duration of effect, the study will also seek to assess the potential clinical trade-offs for patients when using the longer duration option. Plus, the potential new “extra-strength” formulation would expand Evolus’ Jeuveau® offering within neurotoxins.
The full trial is expected to be completed in mid-2023, with the final results anticipated to be presented in the second half of 2023.
“The interim results of this study are a significant step forward in our strategy to provide a longer-duration treatment option to patients, and we are very pleased that the ‘extra-strength’ formulation of Jeuveau® demonstrated a duration of 6 months or 26 weeks,” said the M.D., chief medical officer and head of research and development at Evolus. Rui Avelar. “This data is very encouraging from a safety and efficacy perspective as we are seeing improvement on the GLS scale together with a favourable safety profile.”
“The combination of results from the ‘original strength’ trials and this exciting new ‘extra-strength’ data further reinforces Jeuveau’s® efficacy, offering greater flexibility for clinicians and patients while maintaining a similar safety profile between the two formulations,” further explained the president and chief executive officer of Evolus, David Moatazedi. “‘Extra-strength’ Jeuveau® can be formulated using the same vial used for the ‘original strength’ Jeuveau® simply by modifying the reconstitution. This provides the runway for an exciting option for our customers that already value Jeuveau’s® unique precision profile while delivering natural-looking results.”
Dr David Ecclestone provided independent insight into the results. He is one of the few medical practitioners in the UK to be a lead investigator in clinical trials on the use of all three of the UK-licensed brands of Anti-Wrinkle Injections.
“These are intriguing early results that look promising,” Dr Ecclestone said. “Some of my patients do ask for the option of a longer duration of effect with toxins, but of course, we will have to wait to see the final results from the study before being able to consider this option in our clinics.”
“Previous studies on other toxins have shown enhanced duration with increased dosing in terms of units, which, of course, are unique to the toxin being studied, and are not interchangeable with other toxin units, even though they are often very similar in terms of efficacy,” continues Dr Ecclestone. “What is certainly true is that it is invigorating to have choice and innovation in the neurotoxin space now. This evolution can really benefit how I tailor treatments for my patients, improving both patient satisfaction and retention.”
For more information about Jeuveau®, visit evolus.com.
