PracticalDermatology

The neuromodulator category is not quite as evolved as the filler category—yet. There are currently three botulinum Type A products available for cosmetic uses—Botox Cosmetic (Allergan), Dysport (Galderma), and Xeomin (Merz), and there are few clinical differences between them.

“We are looking for different personalities and that is lacking in aesthetic toxins,” says Steve Yoelin, MD an ophthalmologist in Newport Beach, CA. “Interesting things will result from a new toxin that has new aesthetic and therapeutic properties.”

The Pipeline is Growing

For starters, Bonti’s EB-001, a novel serotype E botulinum neurotoxin (BoNT/E), is characterized by fast onset of action (within 24 hours) and short duration of effect (about four weeks). EB-001 was evaluated in individuals with moderate to severe glabellar lines in a placebo-controlled, ascending dose cohort study that includes a single treatment cycle and follow-up for 28 days. The Phase 2 proof-of-concept clinical data illustrate that EB-001 achieved its objectives and confirmed both the favorable safety and the expected clinical efficacy profile. Bonti is also looking to EB-001 as a non-opioid solution for the treatment of musculoskeletal pain and has already started the first clinical study for this indication based on the dosing confirmation in the recently completed Phase 2 glabellar lines study.

Big barriers among toxin-naïve patients are fears of looking frozen or of pain related to the procedure. “We are expanding the market by bringing in naïve users who are afraid of trying Botox, Millennials who want to try it first before committing to results that last three months, and those who have a last-minute job interview or social occasion and want to see results quickly,” says Fauad Hasan, co-founder and CEO of Bonti.

And this strategy seems to be working. When study participants were asked if they would be interested in a longer-acting neuromodulator after trying Bonti’s investigational product, they overwhelmingly said yes.

If it is approved, the company plans to price EB-001 so that it is attractive for patients and physicians and possibly bundle it with longer-acting products for use down the road.

“The Bonti product is particularly exciting for pain management, for short-term (in between cycles of Botox) ‘syncing,’ for touch-ups to correct asymmetries mid-cycle, or for quick procedures for an important social event or something similar,” adds Brian M. Kinney, MD, FACS, MSME, a clinical associate professor of plastic surgery at the University of Southern California in Beverly Hills, CA.

A Long Shot

Bonti’s product isn’t the only game in town, either. Revance’s lead drug candidate, DaxibotulinumtoxinA for Injection (RT002), currently in clinical development for the treatment of glabellar lines, may last longer than currently approved toxins.

“It is a proprietary formulation of botulinumtoxinA with an innovative peptide technology, which forms a unique electrostatic complex that is hypothesized to stabilize the ingredient (BoNTA). We believe daxibotulinumtoxinA’s duration of effect will set a new standard of performance for neuromodulators, giving patients and physicians a profoundly different clinical experience,” says Roman G. Rubio, MD, Senior Vice President, Clinical Development at Revance Therapeutics.

The effects may last up to six months, which is significantly longer than the three or four months seen with currently available neuromodulators. The company is also developing a topical form that would eliminate the need for needles.

DWP-450, a new 900kDa Botulinum toxin Type A, is also in development for the treatment of glabellar lines. The FDA recently accepted Evolus’ Biologics License Application (BLA) for review, as has the European Medicines Agency (EMA).