New neurotoxin on the block starts phase 3 trials

Tina S. Alster, M.D.The injectable neurotoxin drug candidate daxibotulinumtoxinA for injection (RT002, Revance Therapeutics) started phase 3 SAKURA trials in December 2016. The pair of double-blind, placebo-controlled, North American studies are evaluating single injections of daxibotulinumtoxinA for the treatment of glabellar lines in about 600 patients at several study centers, Tina S. Alster, M.D., an investigator for the phase 3 SAKURA trials tells Dermatology Times.

“These pivotal trials follow on the successful BELMONT study announced last year that showed RT002 at the 40U dose produced six-month duration of effect in the treatment of frown lines,” says Dr. Alster, director of the Washington Institute of Dermatologic Laser Surgery and clinical professor of dermatology, Georgetown University Hospital, Washington, DC.

DaxibotulinumtoxinA (RT002) is designed to be the first long-lasting, next-generation injectable neurotoxin, she says.

“The company’s strategy is to position long-lasting, sustained duration of effect--demonstrated in both cosmetic and muscle movement clinical studies--as the key differentiation of RT002, when compared to the first-generation neurotoxin products currently available,” Dr. Alster says. “RT002 is different because it is a highly purified version of botulinum toxin A, using no animal proteins or human albumin, that has been combined with Revance's proprietary peptide technology. This combination leads to high stabilization and increased duration.”

RT002 appeared to be general safe and well tolerated in phase 1 and phase 2 trials. Adverse events were mild, localized and transient, with the most common effects being headache and erythema.

“For RT002 in the BELMONT study (20U and 40U doses), no subjects experienced ptosis…. There were no serious adverse events or evidence of any systemic exposure at any of the three doses evaluated,” Dr. Alster says.

Revance will complete its two phase 3 pivotal trials this year, and its long-term safety trial in 2018, after which the company will prepare to file its Biologics License Application with the FDA, according to Dr. Alster.