Revance is moving ahead on bringing its pipeline neuromodulator daxibotulinumtoxinA for injection (RT002) to market. RT002, a purified botulinum toxin A, is in phase 3 clinical trials for the aesthetic indication of glabellar line treatment.
RT002 features a proprietary peptide technology which binds the botulinum toxin Type A with a stabilizing excipient peptide, which is thought to contribute to RT002’s longer duration of effect, according to company literature. Another distinguishing feature is that RT002 has no animal-derived components or human albumin.
Dermatologist Gary Monheit, M.D., of Birmingham, Ala., led a Revance-funded study and presented “SAKURA 1 and 2 Phase 3 Pivotal Studies DaxibotulinumtoxinA for Injection (RT002) for the Treatment of Moderate to Severe Glabellar Lines,” February 2018 at the IMCAS conference in Paris, France. link: http://www.revance.com/pdfs/Sakura_1_2_TLR_Presentation_at_IMCAS_3_Feb_18_Gary_Monheit.pdf
The two phase three studies are identical in their design to evaluate the safety and efficacy of a single daxibotulinumtoxinA for injection treatment of 40U for the treatment of moderate to severe glabellar lines compared to placebo. The two studies have a total 405 patients randomized to the treatment arm, versus 204 on placebo. The primary endpoint is the proportion of subjects achieving a score of 0 or 1 (none or mild) and an improvement of 2 or more points from baseline on both the Investigator Global Assessment Facial Wrinkle Severity and Patient Facial Wrinkle Severity scales concurrently at week 4.
Approximately 74% of subjects in each of the SAKURA trials met the primary endpoint at week 4, versus 1% or less of placebo. About 70% of subjects were very satisfied in SAKURA 1 and more than 70% were very satisfied in SAKURA 2.
Researchers also evaluated duration of effect and found 35.5% of subjects treated with RT002 in SAKURA 1 and 29.4% in SAKURA 2 achieved a none or mild response on the investigator Global Assessment Facial Wrinkle Severity scale at week 24:
Among the noted adverse events in the treated versus placebo arms: 5.9% to 7% of patients in the treatment arms reported headache, versus 1% to 2.9% in placebo. Eyelid ptosis occurred in 2% to 2.9% of those treated in the two studies, versus none of the placebo subjects. Overall, 17% to 21% of subjects treated experienced treatment-related adverse effects, versus 8% and 10% in the placebo groups.
Revance plans to complete its SAKURA 3 open-label, long-term safety study at the end of this year and if approved by the FDA for glabellar lines expects to launch the product for that indication in 2020, according to the company.