Revance’s rival to Allergan’s Botox aces phase 3

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Wrinkle severity returned to baseline around 27 weeks—more than six months—after the injection.

A pair of phase 3 trials of Revance Therapeutic’s RT002 have hit all their primary and secondary endpoints. The effect of the neuromodulator on wrinkles lasted for six months, suggesting it poses a threat to Allergan’s blockbuster Botox franchise.

Revance tested RT002, also known as injectable daxibotulinumtoxinA, in more than 600 patients across the two clinical trials. Almost 75% of participants in both studies achieved the primary composite endpoint, which looked for at least a two-point improvement in a type of facial wrinkle known as glabellar line. Next to no patients who received placebo achieved such an improvement.

That shows a single injection of RT002 has a powerful short-term effect on wrinkles. But if the drug is to unseat the incumbent in the medical aesthetics field, Botox, it needs to differentiate itself. The long-term data suggest RT002 has a chance of doing that.

Investigators tracked the participants until their wrinkle severity returned to baseline. RT002 easily beat placebo at every time point against all secondary endpoints that assessed glabellar line up to 24 weeks. Wrinkle severity returned to baseline around 27 weeks—more than six months—after the injection.

That is the data point that could cause consternation at Allergan. The effect of Botox and its rivals wanes after a few months. RT002 looks to have a significantly longer duration of efficacy, a characteristic that some in the medical aesthetics see as a major plus for the drug.

“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,” Joely Kaufman-Janette, M.D., an investigator in the pivotal program, said in a statement. “RT002 appears to provide the look my patients desire over a six-month period, which is remarkable and will fulfill a significant need among my patients.”

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Revance is now pushing forward to gather the last bits of data it needs to file for approval in the U.S. Enrollment in a long-term safety trial is complete, putting Revance on a path it expects to lead to study completion in the second half of next year. If all goes to plan, Revance will file for FDA approval in the first half of 2019 and bring RT002 to market the following year.

One question now is whether Allergan will run the risk of leaving the path clear for a competitor to buy Revance and take aim at its Botox franchise or strike a deal itself to head off the threat.

Revance had a market cap of around $800 million going into the data readout. The stock traded up more than 35% in premarket trading.