Novel benzamide antipsychotic turns in good efficacy, safety results in phase 2 trial

The investigational benzamide LB-102 (N-methyl amisulpride) is well tolerated and helps reduce symptoms in patients with schizophrenia experiencing an acute episode, according to the results of the NOVA1 phase 2 trial.

NOVA1 consisted of an inpatient screening period (≤14 days), 28-day inpatient treatment period, 5-day inpatient stabilization period, and outpatient safety follow-up visit conducted around 2 weeks after the treatment period end.

A total of 359 adult patients (mean age 39.1 years, 80.8 percent male) with schizophrenia who required hospitalization or continued hospitalization for an acute exacerbation of psychotic symptoms participated in the trial. These patients had to have a Positive and Negative Syndrome Scale (PANSS) total score of 80–120, PANSS Positive Symptoms subscale item score of ≥4 on 2 or more key items, and a Clinical Global Impressions–Severity of Illness scale (CGI-S) score of ≥4.

The patients were randomly assigned to receive LB-102 at 50 mg (n=107), 75 mg (n=108), or 100 mg (n=36) or placebo (n=108). Treatment was administered orally, once daily. The primary endpoint was change in PANSS total score at week 4.

NOVA1 met its primary endpoint, with all LB-102 doses showing an association with superior improvements in PANSS total score from baseline to week 4 compared with placebo (−14.3 with 50 mg, −14 with 75 mg, and –16.1 with 100 mg vs −9.3; p<0.001, p=0.002, and p=0.002, respectively).

Treatment-emergent adverse events (TEAEs) occurred in 69 percent of patients in the 50-mg group, 57 percent in the 75-mg group, 75 percent in the 100-mg group, and 56 percent in the placebo group. TEAEs led to treatment withdrawal in two, three, three, and two patients in the respective groups. Five serious TEAEs were documented, including one each in the LB-102 groups and two in the placebo group.