Revance Reports Positive Results in Two Phase 2a Studies of DAXI

Revance Therapeutics, an aesthetic biotechnology company, recently announced positive results for two Phase 2a open-label, dose escalation studies of investigational neurotoxin, DaxibotulinumtoxinA (DAXI), for the treatment of forehead and lateral canthal lines.

The forehead lines study included 61 patients randomized into one of four dose groups that received an initial dose of 40 units of DAXI into the glabellar complex. Two weeks after the initial dose, study patients received injections of either 12, 16, 24, or 30 units in the forehead for a total study duration of up to 38 weeks, according to the press release.

In the lateral canthal lines (crow's feet) study, 63 patients were randomized into one of four dose groups to receive either 12, 24, 36, or 48 units of DAXI, then followed for up to 36 weeks.

In both studies, the primary endpoint for patients was to have a score of none or mild wrinkle or line severity at Week 4. Scores were based on investigator assessment of maximum eyebrow elevation for forehead lines and maximum smile for crow’s feet.

In the forehead lines study, 100% of patients achieved a score of none or mild at Week 4 in at least one treatment group. In the crow’s feet study, 88% of patients achieved a score of none or mild at Week 4 in at least one treatment group.

Both studies also investigated the duration of effect of DAXI in these areas, defined by the median time to return to baseline wrinkle severity, and were assessed by both the investigator and patient. The forehead lines study demonstrated a median effective duration of 27 weeks while the crow’s feet study showed 24 weeks.

DAXI is reported to be well tolerated at all dose levels, with only mild, localized, and transient adverse events noted in the studies. The most common AEs after forehead line treatments were edema (10%), erythema (6.7%), and headache (5%), with a single occurrence of eyelid ptosis that fully resolved by Day 9. The most common AEs after crow’s feet treatment were nasopharyngitis (11.1%), bruising (7.9%), and headache (7.9%).

The interim Week 4 data from both Phase 2a studies were used in the final design of Revance’s current upper facial lines Phase 2 study to optimize dosing and injection patterns. Results from that study are scheduled to be reported in the fourth quarter of 2020. The company’s SAKURA Phase 3 program has also yielded positive results for treating moderate to severe glabellar lines and the subsequent submission for regulatory approval has been given a Prescription Drug User Fee Act (PDUFA) VI program date of November 25, 2020, by the U.S. FDA.

“Exploring DaxibotulinumtoxinA for Injection in other areas of the upper face beyond glabellar lines provides an expanded body of knowledge on the performance of our long-acting, next-generation neuromodulator,” says Mark Foley, Revance president and chief executive officer, in the press release. “These results are consistent with those observed in our SAKURA Phase 3 program for DaxibotulinumtoxinA for Injection in the treatment of glabellar lines. Our aim is to provide physicians and patients with a true advancement in the treatment of not only facial wrinkles, but also a number of debilitating muscle movement and pain disorders, which are being addressed through ongoing therapeutic clinical trials.”