Teva ($TEVA) has posted positive Phase III data for its involuntary twitch candidate deutetrabenazine as its gears up for a 2016 FDA filing--putting it a few months behind rival biotech Neurocrine to be the first to market a new med for the condition.
The Israeli generics giant is gearing up its drug for a license to treat tardive dyskinesia (TD), a condition characterized by involuntary, repetitive movements of the face that can also affect the trunk and extremities.
It is estimated to impact around half a million Americans and is directly linked to medications used to treat psychiatric conditions, such as schizophrenia and bipolar disease.
These symptoms are rarely reversible, and there are currently no FDA-approved treatments. But this could soon change as Teva is not the only company going after this disorder, with Neurocrine Biosciences ($NBIX) announcing last month that it had sent off an NDA with the U.S. regulator for its experimental med--and came earlier than analysts had reckoned.
The biotech’s once-daily valbenazine, a VMAT2 inhibitor that modulates dopamine release during nerve communication, already has a “Breakthrough” tag and could be approved as early as April next year.
Meanwhile, Teva’s late-stage data came from the 12-week AIM-TD study, which showed its med could reduce the so-called Involuntary Movement Scale (AIMS) score from baseline better than placebo. This builds on positive data posted from another 12-week trial last summer.
Breaking down the data, at week 12, the AIMS rating improved from baseline by -3.3 points for 36 mg; -3.2 points for 24 mg; and -2.1 for 12 mg, compared to -1.4 in placebo.
In addition to the primary endpoint, mean scores on the Clinical Global Impression of Change (CGI) improved by -0.5 for the high dose and by -0.6 for the middle dose, based on the modified intent-to-treat population.
The CGI is a formal assessment of the abnormal movements defined by TD made by the treating investigator. For this endpoint, the success of treatment was judged as either “much improved” or “very much improved” after three months. Missing data were counted as treatment failure.
The middle 24-mg dose was shown superior to placebo, but while the high 36-mg dose was also superior to placebo, it did not reach statistical significance. More details are set to be published by Teva in the coming months.
The pharma’s med, which has its own FDA “Breakthrough” tag, is also an inhibitor of vesicular monoamine 2 transporter, or VMAT2, and on top of TD is in testing for chorea associated with Huntington disease, as well as for tics associated with Tourette syndrome, for which the FDA has granted orphan status for pediatric use.
Teva was hit with a setback this year for deutetrabenazine in Huntington’s--a notoriously difficult condition to treat--when in May the FDA rejected its marketing application for the drug in chorea, the involuntary motion that afflicts Huntington’s patients.
But today, the company was happy with its data in TD. “We are delighted to deliver positive results from a second Phase III study showing the potential for SD-809 to treat the involuntary movements of tardive dyskinesia,” said Michael Hayden, president of global R&D at Teva, in a release. "This condition is debilitating and often leads to isolation of those affected. The study results strengthen our resolve to making this product an option for those patients in need. We are grateful to the trial participants and study investigators who contributed to this study.”
Teva got hold of the drug in its $3.5 billion buyout of Auspex last year as it looked to boost its CNS research pipeline.