- Highly statistically significant results on primary composite endpoint achieved at Week 4 -
- RT002 delivered highly statistically significant reduction in severity of glabellar lines at Week 24 -
- If approved, RT002 could represent a new, next-generation, long-acting neuromodulator -
- Revance to host conference call at
If approved by the
Both SAKURA 1 and SAKURA 2 met the primary composite endpoint by delivering highly statistically significant improvement against placebo in reducing the severity of glabellar lines, i.e., the frown lines or wrinkles between the brows. The percent of RT002-treated patients who had none or mild wrinkles and achieved at least a two-point improvement from baseline on both validated physician and patient assessments were 73.6 percent in SAKURA 1 and 74.0 percent in SAKURA 2 compared to placebo (p < 0.0001) at Week 4. Also at that time point, 88 percent of RT002-treated patients in SAKURA 1 and 91 percent of RT002 patients in SAKURA 2 said they were very satisfied or satisfied with their treatment experience.
All secondary endpoints measuring reduction in severity of glabellar lines with RT002 compared to placebo were highly statistically significant at every time point evaluated to 24 weeks. On an additional key secondary endpoint, median duration for patients treated with RT002 to return to baseline wrinkle severity was nearly 27 weeks (SAKURA 1: 27.7 weeks and SAKURA 2: 26.0 weeks) as assessed by both physicians and patients.
"We are extremely pleased with these positive SAKURA top-line results, which reinforce the findings from the
In addition to SAKURA 1 and SAKURA 2, a long-term safety trial, SAKURA 3, is fully enrolled and is expected to be completed in the second half of 2018. Assuming successful completion of SAKURA 3, the company plans to submit a Biologics License Application in the first half of 2019 and, pending approval by the
"Both SAKURA 1 and SAKURA 2 show RT002 delivers consistent long-acting performance, which is unprecedented for a neuromodulator given what we have seen over the last 30 years," said
Treatment of glabellar lines is the most popular aesthetic procedure for an injectable neuromodulator, accounting for nearly a third of the
"Patients in my practice are very savvy - not only do they want their neuromodulator treatment to give them great results, they also want the look to last as long as possible," said
TOP-LINE 36-WEEK RESULTS
The primary efficacy measurement was a composite of the proportion of patients who achieved a score of 0 or 1 (none or mild) and at least a two-point improvement from baseline at maximum contraction (frown) in glabellar line severity on both the Investigator Global Assessment-Facial Wrinkle Severity (IGA-FWS) and Patient Facial Wrinkle Severity (PFWS) scales at Week 4.
- Percent of patients who achieved the primary composite endpoint:
- SAKURA 1: 73.6 percent of patients vs. 0 percent for placebo (p < 0.0001)
- SAKURA 2: 74.0 percent vs. 1.0 percent for placebo (p < 0.0001)
SECONDARY DURATION ENDPOINTS
There were several secondary endpoints used to evaluate duration of effect, including the proportion of patients achieving none or mild response on IGA-FWS compared to placebo, median duration for time to loss of none or mild wrinkle severity on both IGA-FWS and PFWS, and median duration for time to return to baseline on both IGA-FWS and PFWS.
- The percent of patients treated with RT002 who achieved a none or mild response on IGA-FWS at Week 24:
- SAKURA 1: 35.3 percent vs. 2.0 percent for placebo (p < 0.0001)
- SAKURA 2: 29.4 percent vs. 2.0 percent for placebo (p < 0.0001)
- Median duration for time to loss of none or mild wrinkle severity on both IGA-FWS and PFWS for patients treated with RT002:
- SAKURA 1: 24.0 weeks
- SAKURA 2: 23.9 weeks
- Median duration for time to return to baseline wrinkle severity on both IGA-FWS and PFWS for patients treated with RT002:
- SAKURA 1: 27.7 weeks
- SAKURA 2: 26.0 weeks
For comparison, an additional exploratory duration endpoint was evaluated, which mirrors the duration measure used in the
- Median duration of ≥ 1 point improvement from baseline on IGA-FWS for patients treated with RT002:
- SAKURA 1: 24.1 weeks
- SAKURA 2: 24.1 weeks
BELMONT: 23.6 weeks2
RT002 appeared to be generally safe and well-tolerated through the end of study at Week 36. Adverse events were mild, localized and transient. There were no treatment-related serious adverse events. The most common adverse events for RT002 in both studies combined were headache (6.4 percent) and injection site pain (3.7 percent). The incidence of eyelid ptosis and brow ptosis were 2.2 percent and 0.7 percent, respectively.
About SAKURA Phase 3 Clinical Program
The SAKURA clinical program includes SAKURA 1 and SAKURA 2 - two randomized, double-blind, placebo-controlled pivotal trials that were identical in design to evaluate the safety and efficacy of a single administration of RT002 for the treatment of moderate-to-severe glabellar lines in adults from 18 to 75 years of age. The SAKURA 1 and SAKURA 2 trials enrolled a total of 609 patients at 30 sites in the
The primary efficacy endpoint was the composite of the proportion of patients who achieved a score of 0 or 1 (none or mild) and at least two-point improvement from baseline in glabellar line severity on both the Investigator Global Assessment-Facial Wrinkle Severity (IGA-FWS) and Patient Facial Wrinkle Severity (PFWS) scales, at maximum contraction (frown), at Week 4. Duration of the reduction of severity of glabellar lines was assessed as secondary efficacy endpoints.
The program also includes an open-label trial designed to evaluate the long-term safety of RT002 in glabellar lines following both single and repeat treatment administration. The long-term safety trial enrolled more than 2,500 patients at 66 sites in the
About Glabellar Lines
The glabella is the skin between the eyebrows and above the nose. Glabellar lines, often called "frown lines," are vertical lines that develop between the eyebrows and may appear as a single vertical line or as two or more lines and may also appear angled toward the inner corners of the eyebrows. When you frown, the muscles of the lower forehead contract in a downward direction, causing the skin between the eyebrows to crease. Lines are formed by the repeated action of frowning due to the lack of elasticity in the skin. Age, sun exposure, and genetics are contributing factors. Botulinum toxin is used to block the nerve impulses, temporarily inhibiting movement of the muscles that cause the frown lines, giving the skin a smoother, more refreshed appearance.
Based on data from
DaxibotulinumtoxinA for Injection (RT002) is an investigational product. It is a novel, next-generation neuromodulator in development for the treatment of aesthetic and therapeutic conditions, including glabellar lines, cervical dystonia and plantar fasciitis. Created using Revance's proprietary peptide technology, RT002 has the potential to become the first neuromodulator with long-acting duration of six months. This proprietary, stabilizing excipient peptide technology eliminates the need for human- and animal-based components, which carry a potential risk of transmitting pathogens.
Revance has three active clinical programs for RT002 injectable under way. With the SAKURA 1 and SAKURA 2 Phase 3 pivotal trials to treat glabellar lines now completed, Revance plans to complete the SAKURA 3 open-label, long-term safety study in the second half of 2018. For cervical dystonia, the company was recently granted orphan drug designation and plans to initiate a Phase 3 program in 2018. A Phase 2 trial for RT002 for the management of plantar fasciitis is fully enrolled, and the company plans to share results by year end 2017.
Individuals interested in listening to the conference call today,
A replay of the call will be available beginning today at
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Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties include, but are not limited to: the outcome, cost, and timing of our product development activities and clinical trials; the uncertain clinical development process; our ability to obtain and maintain regulatory approval of our drug product candidates; our ability to obtain funding for our operations; our plans to research, develop, and commercialize our drug product candidates; our ability to achieve market acceptance of our drug product candidates; unanticipated costs or delays in research, development, and commercialization efforts; the applicability of clinical study results to actual outcomes; the size and growth potential of the markets for our drug product candidates; our ability to successfully commercialize our drug product candidates and the timing of commercialization activities; the rate and degree of market acceptance of our drug product candidates; our ability to develop sales and marketing capabilities; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for financing; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; and other risks. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in Revance's periodic filings with the Securities and Exchange Commission (the "
1. Data on file
2. Carruthers, J., et al. Injectable DaxibotulinumtoxinA for the Treatment of Glabellar Lines: A Phase 2, Randomized, Dose-Ranging, Double-Blind, Multicenter Comparison with OnabotulinumtoxinA and Placebo. Dermatol. Surg. 2017; 43: 1321 - 1331
Nadine Tosk, 504-453-8344
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