Revance Therapeutics Inc (NASDAQ:RVNC) is trading sharply higher today, currently up $1.60 and sitting comfortably at $20.95 – an eight percent boost. After the closing bell yesterday afternoon, the company released positive 24-week efficacy data from a Phase 2 trial evaluating its cervical dystonia therapy, RT002.
The company developed RT002 as a treatment for moderate-to-severe isolated cervical dystonia, which is sometimes referred to as spasmodic torticollis. It is a painful condition involving patients’ neck muscles contracting involuntarily, resulting in strange movements and uncomfortable posture of the neck and head. The condition can be debilitating.
RT002 – which is a DaxibotulinumtoxinA Injectable – was being assessed in a 24-week clinical program in three different types of cervical dystonia therapy. According to Revance, the median duration of effect observed was at least 24 weeks in all three patient populations – meaning that the drug maintained a clinically meaningful effect through the entire duration of the study. The current standard of care (botox injections) typically wears off in about half that amount of time.
Using the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) as a metric, the primary endpoint in the efficacy study was improvement in signs and symptoms. At the four-week mark, all three cohorts showed an average reduction of 38 percent, and that reduction grew to 50 percent by the sixth week. At week 12, and the average reduction rate was 42 percent. The average across all three cohorts stayed above 30 percent during the whole trial.
As a secondary endpoint, researchers were looking at the improvement in patients’ symptoms using the Clinician Global Impression of Change (CGIC) scale. About 97 percent of the study’s participants said they had an improvement in symptoms on the fourth week.
Apart from that, the product was reportedly observed to be safe and well-tolerated in all three cohorts through the final week of the program. No serious adverse events or dose-dependent increases in adverse events were reported.
According to the company’s Senior Vice President of Clinical Development, Dr. Roman Rubio, the product has the potential to provide sustained relief of signs and symptoms that lasts longer than the current industry standard. In fact, botox-treated patients request retreatment as soon as ten weeks after injections.
“RT002 has potential to manage this debilitating disease with at most two treatments per year, which matters to patients, physicians and payors alike,” said the company’s President and Chief Executive Officer, Dan Browne.
Given these latest efficacy results, Revance is planning on discussing its next moves in the clinical program with American and European regulatory bodies later in 2017.
On the heels of the company releasing the efficacy data, Aegis Capital announced that it was reiterating its Buy rating on the company’s stock – while lifting its 12-month price target from $28.00 to $36.00. Difei Yang, an analyst with the Wall Street firm, said that RT002’s duration of effect is “positive.”
“As such, we believe that what we are seeing in the data is a validation of the delivery vehicle for RT002,” the analyst added. “In our opinion, this should translate into a pricing premium over Botox in medical indications.”
The author of this article holds no positions in any of the companies mentioned above.