LB Pharmaceuticals Unveils Phase 2 LB-102 Data at 2025 Schizophrenia Congress

LB Pharmaceuticals Inc., a biopharmaceutical company in the clinical stage, is advancing its research on LB-102, a promising treatment for schizophrenia. Recently, at the Schizophrenia International Research Society's Annual Congress in Chicago, the company presented encouraging results from its Phase 2 clinical trial, NOVA1. This trial focused on the effects of LB-102 on patients suffering from acute schizophrenia exacerbations. LB-102 aims to fill significant treatment gaps in managing neuropsychiatric disorders.

The NOVA1 trial, a critical component of LB Pharmaceuticals' research, successfully met its primary endpoint. The study demonstrated a statistically significant reduction in the Positive and Negative Syndrome Scale (PANSS) total scores after four weeks of treatment. PANSS is a well-regarded tool used to assess symptoms severity in schizophrenia. Alongside this, the trial also assessed changes using the Clinical Global Impression of Severity (CGI-S) score, which rates overall illness severity on a scale from 1 (normal) to 7 (extremely ill). At the trial's conclusion, participants who received 50 mg of LB-102 showed a mean change in CGI-S score of -0.72 compared to placebo, with those on 75 mg and 100 mg doses showing changes of -0.67 and -0.84, respectively. These results indicate a meaningful clinical impact on disease severity.

Heather Turner, CEO of LB Pharmaceuticals, expressed optimism about the trial outcomes, highlighting the potential of LB-102 to be a groundbreaking treatment for schizophrenia due to its efficacy and safety profile. Turner emphasized that these findings align with the company’s vision of developing a treatment that offers a compelling balance of effectiveness and tolerability, addressing the urgent need for better therapeutic options for schizophrenia patients. The company plans to initiate a Phase 3 clinical trial in the last quarter of 2025, further exploring LB-102's potential as a leading treatment for schizophrenia.

The NOVA1 trial enrolled 359 adults aged 18 to 55, all diagnosed with acute schizophrenia exacerbations according to DSM-5 criteria. The study was structured as a double-blind, placebo-controlled, multi-center inpatient trial. Participants were randomly assigned to receive either a placebo or doses of 50 mg, 75 mg, or 100 mg of LB-102 daily. The primary aim was to evaluate the efficacy of LB-102 in comparison to a placebo in reducing PANSS total scores over 28 days. Secondary objectives included assessing improvements in CGI-S scores, safety, tolerability, and pharmacokinetics.

LB-102 functions as a potent antagonist of dopamine D2/3 and 5HT7 receptors, with minimal off-target activity. In earlier studies, LB-102 significantly improved the symptoms of schizophrenia when administered once daily. The upcoming Phase 3 clinical study is anticipated to begin in late 2025. Furthermore, based on its mechanism of action and preclinical studies, LB Pharmaceuticals plans to initiate clinical trials of LB-102 for bipolar depression, predominantly negative schizophrenia, and Alzheimer's-related agitation and psychosis starting in 2026. If LB-102 receives approval, it would become the first benzamide used in the U.S. to treat psychiatric disorders.

John M. Kane, M.D., who is associated with the NOVA1 trial, remarked on the compelling nature of the CGI-S scores, which, alongside the PANSS results, underscore the potential real-world impact of LB-102 on acute schizophrenia. He noted that while PANSS provides a structured symptom measure, CGI-S offers an independent, clinician-driven assessment of overall disease severity. The trial’s results suggest tangible clinical benefits that could enhance the daily quality of life for patients, thereby addressing a critical gap in current schizophrenia care.

LB Pharmaceuticals, supported by investors such as Deep Track Capital and Vida Ventures, continues its commitment to developing innovative treatments for neuropsychiatric diseases. The company is dedicated to providing comprehensive and generally safe therapeutic options, with LB-102 leading its portfolio as a potential first-in-class benzamide antipsychotic in the U.S.