LB Pharmaceuticals Initiates Pivotal Phase 3 Trial (NOVA-2) for LB-102 in Patients with Schizophrenia
LB-102 has potential to be the first benzamide approved for schizophrenia in the U.S.
NOVA-2 trial to enroll approximately 460 patients
Primary endpoint to evaluate change in PANSS total score at week 6; secondary endpoints
to include evaluations of negative symptoms and cognitive performance as well as safety and tolerability
Topline data expected in 2H 2027
NEW YORK, March 25, 2026 (GLOBE NEWSWIRE) -- LB Pharmaceuticals Inc ("LB Pharmaceuticals" or the "Company") (NASDAQ:LBRX), a late-stage biopharmaceutical company developing novel therapies for schizophrenia, bipolar depression, adjunctive major depressive disorder (MDD), and other neuropsychiatric diseases, today announced the initiation of its pivotal Phase 3 trial (NOVA-2) evaluating the efficacy and safety of LB-102 as a treatment for schizophrenia. LB-102, a novel, once-daily, oral investigational small molecule, is a selective antagonist of D2, D3, and 5HT-7 receptors that is being advanced as a potential first benzamide in the U.S. for the treatment of neuropsychiatric disorders.
"The initiation of the NOVA-2 trial marks a major milestone and underscores our strong and continued focus on execution," said Heather Turner, Chief Executive Officer of LB Pharmaceuticals. "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 2 (NOVA-1) trial, will support the potential U.S. 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 program in both psychosis and mood disorders, we are focused on unlocking the full potential of LB-102."
"There remains significant unmet need for new schizophrenia therapies that provide patients rapid relief from positive symptoms, minimize burdensome adverse effects, and offer potential for improving negative and cognitive symptoms that drive functional impairment. In our robust NOVA-1 trial, LB-102 demonstrated a statistically significant benefit versus placebo in PANSS total score at all doses studied, including rapid onset of effect at week 1 and sustained benefit through the endpoint of the trial, a potentially class-leading safety profile with low rates of EPS (including akathisia), minimal sedation and few GI side effects, as well as effects on negative symptoms and cognitive performance," added Anna Eramo, MD, Chief Medical Officer of LB Pharmaceuticals. "Our Phase 3 trial, NOVA-2, is designed to further elucidate the potential multidimensional benefits of LB-102 across the positive, negative, and cognitive symptom domains of schizophrenia."
Phase 3 NOVA-2 Trial Design
The Phase 3 trial (NCT07363577) is a multi-center, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of LB-102 for the treatment of schizophrenia. The trial is designed to enroll approximately 460 patients with acute exacerbation of schizophrenia at approximately 25 sites in the U.S. Patients will be randomized 1:1:1 to receive either 50 mg or 100 mg of LB-102 or placebo for six weeks. The primary endpoint is the change from baseline in Positive and Negative Syndrome Scale (PANSS) total score at Week 6. Secondary endpoints include Clinical Global Impression-Severity (CGI-S), PANSS positive and negative subscales, Marder factor scores, cognitive performance, and Personal and Social Performance (PSP) scale.
The Company also plans to initiate an approximately 900 patient open label extension trial. Patients who complete NOVA-2 will be able to continue in the Open Label Extension trial that will also enroll de novo patients. This open-label trial is expected to characterize the long-term safety of LB-102 as well as further explore the effects of LB-102 on negative symptoms and cognitive performance.
Topline results from NOVA-2 are anticipated in the second half of 2027 and if positive, the company expects to hold a pre-NDA meeting with FDA thereafter.
About LB-102
LB-102 is a novel, once-daily, orally administered investigational small molecule and potential first benzamide antipsychotic in the U.S. for the treatment of neuropsychiatric disorders. A methylated derivative of amisulpride, a widely used antipsychotic outside the U.S., LB-102 was developed to retain amisulpride's benefits while addressing its limitations. LB-102 is a potent and selective antagonist of D2, D3, and 5HT-7 receptors with few off-target effects and broad therapeutic potential across psychosis and mood disorders. In early 2025, LB Pharmaceuticals announced positive data from a four-week placebo-controlled, double-blinded, Phase 2 trial in patients with acute schizophrenia. In this trial, LB-102 demonstrated statistically significant benefit versus placebo at all doses studied, including rapid onset of effect at week 1 and sustained benefit through the endpoint of the trial, a potentially class-leading safety profile with low rates of EPS (including akathisia), minimal sedation and few GI side effects, alongside effects on negative symptoms and cognitive performance. These data underscore LB‑102's potential to address multiple domains of neuropsychiatric illness. A Phase 3 clinical trial (NOVA-2) of LB-102 for schizophrenia and a Phase 2 clinical trial (ILLUMINATE-1) of LB-102 for bipolar depression have been initiated, and a Phase 2 trial in adjunctive treatment of MDD is planned. Additional expansion opportunities for LB-102 include predominantly negative symptoms of schizophrenia, Alzheimer's disease psychosis and agitation, as well as other neuropsychiatric diseases.
About Schizophrenia
Typically diagnosed in the late teen years to early thirties, schizophrenia is a chronic, severe, complex, and debilitating psychiatric disorder that affects approximately 1% of the U.S. population and is a leading cause of disability. Symptoms of schizophrenia are typically grouped into three categories, or domains: 1) Psychotic or positive symptoms, such as hallucinations, delusions, thought disorder, and movement disorder; 2) Negative symptoms, such as loss of motivation, interest, or enjoyment in daily activities, withdrawal from social life, and difficulty in showing emotions; and 3) Cognitive symptoms, such as problems in attention, concentration, and memory. While antipsychotic drugs are commonly used to treat schizophrenia, most currently approved medications have significant side effects, primarily address positive symptoms of schizophrenia, and are often not effective in treating negative and cognitive symptoms. There is currently no cure for schizophrenia, which means the disease must be managed with life-long therapy, increasing the importance of therapies that can address symptoms across all domains as well as adherence rates and dosing challenges.
About LB Pharmaceuticals
LB Pharmaceuticals is a late-stage biopharmaceutical company developing novel therapies for the treatment of schizophrenia, bipolar depression, the adjunctive treatment of MDD, and other neuropsychiatric diseases. The Company is building a pipeline that leverages the broad therapeutic potential of its lead product candidate, LB-102, which the Company believes has the potential to be the first benzamide antipsychotic drug approved for neuropsychiatric disorders in the United States. LB-102, if approved, has the potential to become a mainstay of psychiatric practice by offering a balanced clinical activity and tolerability profile that provides a potentially attractive alternative to branded and generic therapeutics for the treatment of schizophrenia, bipolar depression, adjunctive MDD, and other neuropsychiatric diseases.
Cautionary Note Regarding Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "aim," "anticipate," "assume," "believe," "contemplate," "continue," "could," "design," "due," "estimate," "expect," "goal," "intend," "may," "objective," "plan," "positioned," "potential," "predict," "seek," "should," "target," "will," "would" or similar expressions are intended to identify forward-looking statements. All statements other than statements of historical facts contained in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements concerning the expected clinical development and regulatory pathway and therapeutic benefits of LB-102; and the design, objectives, initiation, timing, progress and results of current and future clinical trials of LB-102, including the Phase 3 NOVA-2 trial and the Open Label Extension trial. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: the Company's limited operating history and historical losses; the Company's ability to raise additional funding to complete the development and any commercialization of LB-102; the Company's dependence on the success of its lead product candidate, LB-102; the Company's ability to obtain regulatory approval of and successfully commercialize its product candidate; the early stages of clinical development of the Company's lead product candidate, LB-102; any undesirable side effects or other properties of the Company's product candidate; that the Company may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; the Company's ability to obtain, maintain and protect its intellectual property; and the Company's dependence on third parties in connection with manufacturing, clinical trials and preclinical studies.
These and other risks are described more fully in the section titled "Risk Factors" in the Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2025 and its other documents to be subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Media and Investor Contact:
Ellen Rose
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