Karuna Therapeutics ( KRTX Quick Quote KRTX - Free Report) announced positive top line data from the phase III EMERGENT-3 study, which evaluated the efficacy, safety and tolerability of its lead pipeline candidate, KarXT (xanomeline-trospium), in adults with schizophrenia.
KarXT exhibited a statistically significant and clinically meaningful 8.4-point reduction in the Positive and Negative Syndrome Scale (PANSS) total score over placebo at week five, meeting the study’s primary endpoint. PANSS is a scale for measuring schizophrenia symptom severity. The drug’s safety profile was also consistent with previously conducted clinical studies.
The EMERGENT-3 study also showed that treatment with KarXT demonstrated reductions in both positive symptoms (like hallucinations or delusions) and negative symptoms (like, difficulty enjoying life or withdrawal from others) of schizophrenia, the secondary endpoints of the study. While treatment with the drug did achieve a statistically significant reduction in the positive symptoms, it did not meet the threshold for statistical significance in negative symptoms.
Though Karuna’s stock initially rose in the pre-market on Mar 20 following the news, shares were down 4.8% in active trading hours, likely as the EMERGENT-3 study did not achieve all of its secondary endpoints. In the year so far, shares have declined 7.1% against the
industry’s fall of 7.2%. Image Source: Zacks Investment Research
The EMERGENT-3 study is a part of the broader EMERGENT clinical program, which is evaluating KarXT for treating acute psychosis in adults with schizophrenia. The program also consists of one completed phase II study (EMERGENT-1), one completed phase III study (EMERGENT-2) and two ongoing late-stage studies, namely EMERGENT-4 and EMERGENT-5, evaluating the efficacy and long-term safety of KarXT in adults with schizophrenia.
Per management, overall data from the EMERGENT program has shown that treatment with Kar-XT addresses schizophrenia symptoms without the common side effects associated with the current treatment options. The company will discuss data from the EMERGENT program with the FDA in the upcoming pre-NDA meeting in second-quarter 2023 for a planned new drug application (NDA) filing for KarXT as a treatment for schizophrenia in mid-2023.
Apart from schizophrenia, Karuna Therapeutics is developing KarXT as a potential treatment for dementia-related psychosis (DRP). The company initially focuses on developing KarXT for the treatment of psychosis in AD, one of the most prevalent subtypes of DRP as a part of the ADEPT clinical program. The company started the phase III ADEPT-1 study in third-quarter 2022, which is evaluating KarXT for psychosis in elderly patients with moderate to severe psychosis related to AD. Two more studies – ADEPT-2 and ADEPT-3 – are expected to start later this year.
Zacks Rank & Stocks to Consider
Karuna currently carries a Zacks Rank #3 (Hold).Some better-ranked stocks in the overall healthcare sector include
Adaptive Biotechnologies Corporation ( ADPT Quick Quote ADPT - Free Report) , Atara Biotherapeutics ( ATRA Quick Quote ATRA - Free Report) and AVITA Medical ( RCEL Quick Quote RCEL - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see . the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
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