Innovative Therapeutics in Oncology and Neuroscience
47
KarXT
Improvement In Positive And Negative Symptoms Of Schizophrenia Substantially
Consistent Safety/Tolerability Profile Across Trials
Clinically Meaningful Reductions on Key Secondary Endpoints
Locations
PANSS Positive
Subscore (Week 5)
PANSS Negative
Subscore (Week 5)
KarXT
Placebo
Pbo.Adj
KarXT
Placebo
Delta
3.2
EMERGENT-1
US
-5.6
-2.4
-3.2
-0.9
p<0.0001
2.3
p<0.001
2.9
EMERGENT-2
US
-6.8
-3.9
-3.4
-1.6
p<0.0001
1.8
p<0.01
3.5
EMERGENT-3
US + Ukraine
-7.1
-3.6
-2.7
-1.8
p<0.0001
0.8
p=0.12
KarXT generally well-tolerated across EMERGENT-1, 2 and 3
TEAES (≥5%) mild to moderate in severity, mostly cholinergic and resolving over time with repeated dosing
Not associated with common AES of atypical antipsychotics (weight gain, EPS, somnolence)
Zai to complete enrollment of the bridging study for schizophrenia in China in 4Q'24;
U.S. NDA accepted with PDUFA goal date of September 26, 2024
Abbreviation: extrapyramidal symptoms (EPS).
Source: Karuna corporate presentaiton, May 2023.
Late-stage
Clinical Data -
NeuroscienceView entire presentation