LB Pharmaceuticals has started its pivotal Phase III NOVA-2 trial to assess the safety and efficacy of its investigational therapy, LB-102, to treat schizophrenia.
The randomised, multi-centre, placebo-controlled, double-blind trial will enrol nearly 460 patients with acute exacerbation of schizophrenia across 25 US sites.
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Patients will be randomised evenly to receive either 50mg or 100mg of the therapy, or a placebo, for a duration of six weeks.
The trial’s primary endpoint is the variation in the total score on the Positive and Negative Syndrome Scale (PANSS) at week six.
Secondary endpoints include PANSS positive and negative subscales, clinical global impression-severity (CGI-S), Marder factor scores, cognitive performance, and personal and social performance (PSP) scale.
LB Pharmaceuticals also intends to commence an open-label extension study involving up to 900 patients. Patients completing NOVA-2 can enrol in this extension or join as new participants.
This trial aims to further evaluate the long-term safety of LB-102 and study its impact on negative symptoms and cognitive outcomes.
LB Pharmaceuticals expects topline results from NOVA-2 in the second half of 2027. If outcomes are positive, the company plans to pursue a pre-new drug application (NDA) meeting with the US Food and Drug Administration (FDA).
LB-102 is an oral small molecule developed as a selective antagonist of D2, D3, and 5-HT7 receptors.
LB Pharmaceuticals CEO Heather Turner said: “The initiation of the NOVA-2 trial marks a major milestone and underscores our strong and continued focus on execution. NOVA-2 is designed to build on the compelling clinical activity and safety profile that LB-102 has demonstrated to date.
“Based on positive results and prior FDA feedback, we believe NOVA-2, together with the open-label extension trial, and data from our Phase II (NOVA-1) trial, will support the potential US approval of LB-102 for the treatment of schizophrenia.
“We believe that LB-102 has the potential to become a mainstay of psychiatric practice by offering patients a balanced clinical benefit and tolerability profile. With our broad development programme in both psychosis and mood disorders, we are focused on unlocking the full potential of LB-102.”
