LB Pharma’s Novel Antipsychotic LB-102 Shows Promising Phase II Results for Schizophrenia
LB-102 is a potential first-in-class benzamide antipsychotic being developed for schizophrenia in the US
The Phase II NOVA trial met its primary endpoint, showing statistically significant reductions in PANSS total scores compared to placebo
359 patients with acute schizophrenia were enrolled in the trial
Three doses were tested:
50 mg, 75 mg, and 100 mg once daily
All doses showed significant improvements over placebo:
50 mg:
5.0 point reduction (p=0.0009)
75 mg:
4.7 point reduction (p=0.0022)
100 mg:
6.8 point reduction (p=0.0017)
LB-102 was generally safe and well-tolerated, with low rates of side effects like extrapyramidal symptoms
The safety profile was comparable to amisulpride, a well-tolerated antipsychotic used outside the US
LB-102 is a methylated derivative of amisulpride designed for once-daily dosing
LB Pharma plans to advance LB-102 to Phase III trials
This could potentially revive the benzamide class of antipsychotics for use in the US market
The positive results suggest LB-102 may offer a new treatment option for schizophrenia patients in the US, with the potential for improved efficacy and tolerability compared to current antipsychotics. However, Phase III trials are still needed to confirm these promising findings.