Botulinum toxin treats neck dystia! DaxibotulinumtoxinA Phase 3 clinical success, Fosun Pharma introduced to China development!

October 15, 2020 // -- Revance Therapeutics is a biotechnology company focused on innovative aesthetics and therapeutic products.
, the company recently announced positive top-line results for Phase 3 ASPEN-1 clinical trials.
this was a randomized, double-blind, placebo-controlled, parallel group 3 trial that evaluated the efficacy and safety of Daxibotulinumtoxin A Botox (RT002) in treating neck dystick disorders.
dystia is a chronic, debilitating neurological disorder that affects the neck muscles.
301 subjects in this critical trial at 60 clinical sites in the United States, Canada and Europe.
study, subjects were randomly grouped at 3:3:1 and received a single dose of 125 units, 250 units of DaxibotulinumtoxinA, placebo injections, and followed up for 36 weeks.
results showed that both doses of DaxibotulinumtoxinA achieved the main therapeutic endpoint: clinically significant improvements in symptoms and signs of neck dystatic disorders in weeks 4 and 6.
specific data were: patients treated with 125 units and 250 units of DaxibotulinumtoxinA compared to the placebo group, in terms of the total score of the spastic oblique neck assessment scale (TWSTRS) in western Toronto Greater statistically significant changes compared to the baseline (12.7 and 10.9 vs.4.3, respectively, p.lt;0.0001 and p=0.0006).
based on a medium time of 80% disappearance of peak therapeutic effect, the medium efficacy duration of 125 unit dose groups and 250 unit dose groups was 24.0 weeks and 20.3 weeks, respectively.
study, DaxibotulinumtoxinA was generally safe, with good tolerance for both doses and encouraging safety.
Revance expects the results of another parallel Phase 3 open-label, long-term safety clinical trial, ASPEN-OLS, to be available in 2021, with 354 subjects in the group. Dr Joseph Jankovic,
investigator for the trial and founder and director of the Parkinson's Disease Center and The Sports Disorders Clinic at Baylor College of Medicine, said: "I am pleased to see the level and duration of relief shown by DaxibotulinumtoxinA in patients in the ASPEN-1 trial.
currently, most patients with cervical dystia go to the hospital 3-4 times a year, which places a heavy burden on their time and schedule.
if a drug can provide longer efficacy and thus reduce the number of injections per year, I think patients will find this very beneficial. Mark Foley, President and CEO of
Reavices, said: "We are pleased to report these positive results from the ASPEN-1 Phase 3 trial, as this is the company's second successful Phase 3 project that demonstrates the extended duration of DaxibotulintoxinA and now spans two different treatment categories - aesthetics and therapeutics.
in addition to laying the foundation for our treatment franchise, these results enhance its potential in other muscle movements and pain disorders.
treatment options for neck dystatic disorders with longer efficacy have the ability to provide patients with meaningful prolonged symptom relief, while also providing a compelling pharmaceutical economics feature.
look forward to continuing to leverage the differentiated performance of the Note DaxibotulinumtoxinA in the global neuromodulative market.
RT002 is a long-acting neuromodulator developed based on Revance Therapeutics proprietary technology platform Pepte Companion Technology (TransMTS), whose active drug ingredient is Daxibotulinumtoxin Type A Botox, which contains no human blood-sourced substances or animal-sourced proteins and maintains 2 years of stability without refrigeration.
based on its completed preclinical and clinical findings, RT002 can be used for cosmetic adaptations, such as the elimination of moderate to severe eyebrow tattoos, and for the treatment of adhesive disorders such as neck dystiosis.
long-lasting is the biggest feature of RT002 compared to the now commonly used botulinumtoxinA, which is derived from the patented peptide technology TransMTS, which makes highly positively charged Sheng peptide and "Daxi" (150kD active medical ingredients; BoNT/A molecules) form a non-co-priced bonding effect, correctly guide the active ingredients to the target site and prevent aggregation due to temperature, thus playing an important role in stabilizing the active ingredients.
In December 2018, Fosun Pharma Pharmaceuticals, a controlling subsidiary of Fosun Pharmaceuticals, entered into a partnership license with Revance Therapeutics to exclusively use, import, sell and commercialize (excluding manufacturing) DaxibotulinumtoxinA within the region and in the field, authorizing applications including cosmetic and therapeutic adaptations, and Fosun Pharmaceuticals paid Revance up to $88 million in licensing fees and corresponding sales milestones as agreed.
may this year, Fosun Pharma's cumulative research and development investment in RT002 has exceeded 200 million yuan (unaudited, including licensing fees).
() Origin: Revance Reports Positive Results from ASPEN-1 Phase 3 Trial of DaxibotulinumtoxinA for Injection in Cervical Dystonia.