Valbenazine Kinect-3 results
In Neurocrine Biosciences’ (NBIX) phase three trial Kinect-3, investigational therapy Valbenazine has managed to demonstrate statistically significant improvement as compared to the placebo as a treatment option for tardive dyskinesia (or TD). This effect was observed for both dosages tested in the trial, 40 mg and 80 mg. Compared to the baseline, the lower dosage resulted in about a two-point decline in the abnormal involuntary move (or AIMS) scale, while the higher dosage resulted in a three-point decline in the AIMS score.
According to the Encyclopedia of Mental Disorders, “The Abnormal Involuntary Movement Scale (or AIMS) is a rating scale that was designed in the 1970s to measure involuntary movements known as tardive dyskinesia (TD). TD is a disorder that sometimes develops as a side effect of long-term treatment with neuroleptic (antipsychotic) medications.” If Valbenazine manages to secure FDA approval for TD, it will prove beneficial for share prices of Neurocrine Biosciences as well as those of the Biotech ETF (BBH). Neurocrine Biosciences makes up about 1.3% of BBH’s total portfolio holdings.
Higher efficacy metric
Unlike the historical industry standard of measuring efficacy as a ~30% reduction in the AIMS score from the baseline, Neurocrine Biosciences has raised the bar in the Kinect-3 study to a decline of over 50% in the AIMS score in six weeks. While the responder rate was only 9% for patients on the placebo, the 40 mg Valbenazine dosage resulted in a 24% responder rate, while the 80 mg dosage resulted in a 40% responder rate.
Currently, many TD patients have been using antipsychotics as a therapy to reduce abnormal movements. Valbenazine has managed to demonstrate efficacy based on AIMS score as well as CGI-TD score despite the patient’s previous history of antipsychotic medication use. Thus, based on its strong efficacy profile, Valbenazine may help make Neurocrine Biosciences a profitable biotechnology company similar to peers such as Biogen (BIIB), Amgen (AMGN), and Celgene (CELG).
In the next article, we will explore growth prospects for Valbenazine in the Tourette syndrome area.