Phase III data for KINECT-HD study evaluating valbenazine for chorea associated with Huntington disease is presented at AAN 2022.- Neurocrine Biosciences
Neurocrine Biosciences, Inc. announced results from the Phase III KINECT-HD study, which demonstrated once-daily administration of valbenazine was associated with significant improvement in chorea associated with Huntington disease (HD) compared with placebo.
These data (abstract #1199) will be shared as an oral presentation Tuesday, April 5th during the Emerging Science Session at the American Academy of Neurology (AAN) 2022 "Great Neuro Reunion" annual meeting in Seattle, Washington.
The KINECT-HD study met its primary endpoint of change in chorea severity using the TMC score of the UHDRS from screening period baseline to maintenance period. Improvement in the TMC score was significantly greater with valbenazine versus placebo, with a placebo-adjusted mean reduction of 3.2 units vs placebo (p<0.0001). improvements in the tmc score with valbenazine were seen as early as week 2, and tmc scores continued to improve versus placebo throughout the dose adjustment and maintenance periods.></0.0001).>
The secondary endpoints of Clinical Global Impression of Change (CGI-C) Response Status and Patient Global Impression of Change (PGI-C) Response Status also significantly favored valbenazine treatment. Patients achieving "much improved" or "very much improved" status were classified as responders. Using this classification, at Week 12, the response rate in the valbenazine group was 42.9% for CGI-C compared to 13.2% in the placebo group (p<0.001). the response rate at week 12 for pgi-c was 52.7% in the valbenazine group and 26.4% in the placebo group (p><0.01). response rates favoring valbenazine were seen as early as week 4 for cgi-c and week 2 for pgi-c. the secondary endpoints of neuro-qol upper and lower extremity physical function endpoints at week 12 were not significantly different between the treatment groups.></0.01).></0.001).>
Treatment emergent adverse events, including somnolence, fatigue, fall, and akathisia, were mild to moderate and consistent with the known safety profile of valbenazine. No suicidal behavior or worsening of suicidal ideation was observed in the valbenazine-treated subjects in this study..
Related news and insights
The FDA has approved crizotinib (Xalkori) for the treatment of unresectable, recurrent, or refractory inflammatory anaplastic lymphoma kinase (ALK)-positive myofibroblastic tumors (IMT) in adults and children over 1 year of age.
Bayer announced the FDA has approved a supplemental New Drug Application (sNDA) for the oral androgen receptor inhibitor (ARi) Nubeqa (darolutamide) with docetaxel for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC).
Myovant Sciences and Pfizer Inc. announced that the FDA)has approved Myfembree (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) as a one-pill, once-a-day therapy for the management of moderate to severe pain associated with endometriosis in pre-menopausal women, with a treatment duration of up to 24 months.