Segal Trials Leads Phase 2 Schizophrenia Trial of LB-102 Toward Primary Endpoint

MIAMI LAKES, Fla.--(BUSINESS WIRE)--Segal Trials, a privately held clinical research network specializing in acute schizophrenia and other psychiatric disorders, has released enrollment performance metrics from their participation in NOVA - a Phase 2 dose finding trial in adult patients with acute schizophrenia evaluating LB-102, a once-daily orally administered small molecule and potential first-in-class benzamide antipsychotic.

Sponsored by NYC-based LB Pharmaceuticals, Inc., the study’s positive topline results were presented at the 43^rd Annual J.P. Morgan Healthcare Conference on January 13^th. Having met its primary endpoint, the study showed LB-102 to be efficacious, generally safe, and well-tolerated over the course of the 4 week treatment period.

“Despite available medications for schizophrenia, many patients continue to suffer from the burden of untreated symptoms or suffer tolerability issues,” said Rishi Kakar, M.D., Chief Scientific Officer at Segal Trials and investigator on the Phase 2 trial. “LB-102 study data is very encouraging and highlights the potential of this novel once daily option to address large unmet need.”

Enrollment Performance

Two Segal Trials investigators, Rishi Kakar, MD and Olga Lapeyra, MD, accounted for 18% of the total sample size in the Phase 2 study. A consistent top-enroller in acute schizophrenia clinical trials, Segal Trials contributed to the study sample size with a rate of randomization of 8 subjects per month over the course of 7 months at a measure of 147% over their contracted enrollment goal.

“Being a consistent lead enroller in acute schizophrenia trials is a testament to our community based outreach and patient centric approach,” said Bonnie Segal, President of Segal Trials. “It’s particularly rewarding when these efforts lead to positive study outcomes.”

Miami Lakes Medical Research

Founded in 1998, Segal Trials cut ribbon at Miami Lakes Medical Research in 2019 in response to the urgent need for research space in acute psychiatric populations. The site is a 10,000 sq ft. free-standing facility dedicated full-time to clinical research, and was designed to allow for flexibility in the execution of the ever more complex clinical trials of today. Segal Trials’ Miami Lakes Medical Research is fitted with 29 beds in a controlled-access research unit across two (2) separate research wings that segregates special populations from one another. As a wholly-owned building, Segal Trials reserves the ability to configure the unit to accommodate various populations and study designs based on need. Since opening their doors the site has enrolled more than 800 subjects across 50 unique clinical trials.

Looking Ahead

In accordance with the positive topline results, LB Pharmaceuticals plans to engage with the U.S. Food & Drug Administration (FDA) to finalize Phase 3 trial design by early 2026.

Schizophrenia affects approximately 1% of the global population, with many individuals experiencing episodes of acute psychosis that significantly impact their quality of life. Current treatment options, while effective for many, leave a significant portion of the patient population underserved, highlighting the urgent need for innovative therapeutic alternatives like LB-102.

Segal Trials is currently accepting new enrollees on their clinical studies and evaluating new studies with sponsors. For more information about Segal Trials, or to schedule an interview, please contact Segal Trials at [e-mail].

About Segal Trials

Segal Trials is a leading clinical research network specializing in the study of psychiatric and neurological conditions. Founded in 1998, Segal Trials operates multiple state-of-the-art facilities in South Florida, dedicated to high-quality clinical trials aiming to advance medical science and improve patient outcomes. For more information and to learn about opportunities to participate in clinical trials, visit their website at www.segaltrials.com.