Revance Therapeutics Inc (NASDAQ:RVNC) recently released the topline results of its ASPEN-1 Phase 3 trial, a placebo-controlled, randomized, and double-blind trial to evaluate DaxibotulinumtoxinA as a potential therapy for cervical dystonia.
DaxibotulinumtoxinA is a pipeline therapy that Revance Therapeutics has been developing as a potential treatment for a chronic neurologic disease called cervical dystonia that affects neck muscles. The company revealed that the topline results from the ASPEN-1 phase 3 study were favorable. The study was conducted on 60 sites in Europe, Canada, and the U.S, with 301 subjects enrolled.
The results of the study indicate that DaxibotulinumtoxinA was well tolerated and it had a good safety profile. The study achieved its primary endpoints in the two doses after showing a decline in cervical dystonia symptoms from around 4 to 6 weeks. The researchers also observed that individuals treated with 125 Units and 250 Units of the treatment had statistically higher changes compared to the baseline which received 12.7 and 10.9 units.
“I was delighted to see both the degree and duration of relief that DaxibotulinumtoxinA for Injection provided trial subjects in ASPEN-1,” stated Dr. Joseph Jankovic, a neurology professor who was one of the investigators in the study.
A focus on delivering long-lasting therapeutic effects to reduce visits to physicians for injections
Dr. Jankovic also noted in his statement that cervical dystonia patients usually have to visit their doctors 3 or 4 times annually to get injections. This may negatively affect the patients in terms of time and resources spent just to get those injections. Dr. Jankovic believes that a treatment that can potentially deliver longer-lasting effects that necessitate fewer trips to the doctor would deliver more value to patients.
Mark Foley, the CEO of Revance expressed excitement about the positive findings observed from the phase 3 clinical study. The excitement was particularly because the ASPEN-1 phase 3 trial is the second phase 3 trial to demonstrate DaxibotulinumtoxinA’s ability to deliver longer-lasting therapeutic relief. The CEO also believes that a treatment that can relieve symptoms for longer durations will be appealing to patients suffering from cervical dystonia.
