Amisulpride

A private startup looking to bring an old schizophrenia drug class to the US has released new Phase 2 data and aims to start a pivotal trial this year. On Wednesday, LB Pharmaceuticals said its experimental treatment LB-102 improved patient symptoms compared with placebo in a schizophrenia rating score called the PANSS after four weeks. All three dose levels tested across 359 patients achieved statistical significance, the company said. It will next need to raise more money to run an additional study, CEO Heather Turner told Endpoints News , and that could come through either a private raise or an IPO. “We’d like to start with the private financing and see how that goes,” Turner said. “And then if the markets are there, we’ll do a public one as well.” LB-102 is a derivative of the antipsychotic medication amisulpride, which has been approved in some European countries since the 1990s. The drug was previously in development in the US: first by the French pharma company Synthélabo, and then by Sanofi after their 1999 merger. But Sanofi discontinued the drug in 2000 “based on IP” reasons, according to an LB investor deck from 2023 . At the time, the FDA had requested that researchers run an additional study. LB wants to bring an updated version of the drug to the US. LB-102 is in the same class as amisulpride — a dopamine D2 receptor antagonist — but modified slightly to add what’s known as a “methyl group,” lead trial investigator John Kane told Endpoints. That allows for easier penetration through the blood-brain barrier with a lower dose than amisulpride, curbing some side effects. “We have an opportunity to bring this medication to use in the US where, obviously, we have many patients with many unmet needs, many patients who change medications frequently,” Kane said. LB hopes the different class effects may help LB-102 eventually compete with Cobenfy, the recently approved schizophrenia drug from Bristol Myers Squibb. Cobenfy is the first new drug from its class of muscarinic receptor agonists, and Bristol Myers has played up that superlative in marketing the drug to schizophrenia patients. But the Phase 3 study for LB-102 will have to come first — and many schizophrenia drugs have failed at that phase after showing promising mid-stage data. Turner said the company is still deciding how it wants to design the trial and which of the three doses it wants to advance. The 50 mg dose induced a five-point reduction in the PANSS total score, the 75 mg dose coaxed a 4.7-point reduction, and the 100 mg dose saw a 6.8-point reduction. P-values for all of the dose arms were 0.0022 or below. LB last put together a funding round in January 2024, securing $75 million in a Series C, and has raised a total of about $122 million. The company had reportedly been considering an IPO as recently as June, but the public offering never materialized.

Turner, a seasoned biotechnology executive, was formerly CEO of Carmot Therapeutics, which was acquired by Roche in 2024 for $2.7 billion LB Pharma’s lead asset, LB-102, is a patent protected blood-brain barrier-optimized analog of amisulpride, a well-established antipsychotic widely used in EuropeLB-102 is designed to address both the positive and negative symptoms of schizophreniaLB Pharma expects to announce top-line data from its LB-102 Phase 2 trial in the first quarter of 2025LB Pharma is backed by institutional investors Deep Track Capital, TCGx Crossover, Vida Ventures, and Pontifax NEW YORK, Nov. 19, 2024 (GLOBE NEWSWIRE) -- LB Pharmaceuticals Inc, a clinical-stage biopharmaceutical company advancing treatments for schizophrenia, today announced the appointment of Heather Turner as Chief Executive Officer and member of the Board of Directors. Ms. Turner succeeds Zachary Prensky, co-founder of LB Pharma, who will serve as an advisor to the CEO through the end of 2024. Mr. Prensky will remain on the Board and contribute as a consultant thereafter. Treating both the positive symptoms of schizophrenia, such as hallucinations and delusions, and the negative symptoms, including flat affect and social withdrawal often linked to depression, presents a significant challenge due to the distinct underlying mechanisms driving these symptom domains. No approved drug in the U.S. has been able to fully address these symptoms. While second generation antipsychotics offer benefits, negative symptoms remain a major unmet need to provide comprehensive schizophrenia care. “I am thrilled to join LB Pharma at such a pivotal moment in its journey to meaningfully augment the psychiatric treatment paradigm,” said Heather Turner, Chief Executive Officer of LB Pharmaceuticals. “With LB Pharma announcing its phase 2 topline data in the first quarter of next year, we have an exceptional opportunity to make a profound impact on the lives of patients living with schizophrenia. The significant unmet need in schizophrenia, particularly in addressing both positive and negative symptoms, remains a critical challenge, and LB-102 is uniquely poised to bridge this gap. I look forward to building on the strong foundation established by Zach and the team, driving the company toward the successful completion of our Phase 2 trial, and preparing for the next phase of our growth.” Ms. Turner brings to LB Pharma over two decades of executive leadership experience in the biotechnology industry, with a proven track record of driving growth and executing high-value transactions. Most recently, as President and Chief Executive Officer of Carmot Therapeutics, she led the company’s successful $2.7 billion acquisition by Roche, a culmination of a dual-track IPO and strategic transaction process. Prior to Carmot, she held key leadership roles at Lyell Immunopharma, Sangamo Therapeutics, and Atara Biotherapeutics, where she oversaw organizational builds, major financings - including an IPO - and critical strategic partnerships. Under Zach Prensky’s leadership since founding the company in 2015, LB Pharmaceuticals has made significant strides in the development of LB-102, which if approved, would be the first-in-class benzamide for the treatment of schizophrenia in the U.S. Zach Prensky, Co-Founder and Board Member of LB Pharmaceuticals, commented: “It has been an incredible journey leading LB Pharma, alongside our team, LB Pharma investors, as well as the patient and physician community, and I am proud of the milestones we’ve achieved in advancing LB-102 as a potentially meaningful option for schizophrenia treatment. Heather’s leadership and track record of delivering value will be instrumental as LB Pharma enters this exciting next phase. I look forward to supporting her and the team as we continue to make progress.” Scott Garland, Chairman of the Board of LB Pharmaceuticals, added: “Heather’s expertise in leading clinical-stage companies, coupled with her deep understanding of strategic execution and operational excellence, makes her the ideal leader to guide LB Pharma through its next chapter of growth. As we approach key milestones, including the completion of our Phase 2 trial, Heather’s leadership will be instrumental to unlocking the value and potential of LB-102.” About LB PharmaceuticalsLB Pharmaceuticals is a clinical-stage biopharmaceutical company dedicated to transforming the treatment of schizophrenia by developing innovative therapies that address both the positive and negative symptoms of the disease. The company’s lead candidate, LB-102, is a second-generation antipsychotic designed to provide comprehensive symptom relief with a superior safety and tolerability profile, addressing critical gaps in the current standard of care. LB Pharmaceuticals is backed by institutional investors Deep Track Capital, TCGx Crossover, Vida Ventures, and Pontifax. About LB-102LB-102 is a blood-brain barrier-optimized analog of amisulpride, a well-established antipsychotic widely used in Europe, which if approved would be the first-in-class benzamide in the U.S. for the treatment of schizophrenia. LB-102 is designed to improve upon the efficacy and safety profile of its predecessor by targeting both positive symptoms (e.g., hallucinations, delusions) and negative symptoms (e.g., social withdrawal, lack of motivation) of schizophrenia. The drug has shown promising results in early trials and is currently in Phase 2 clinical development, aiming to deliver a transformative solution for patients and healthcare providers. Media Contact: Kristin Politi, Ph.D. VP, Media Strategy LifeSci Communications kpoliti@lifescicomms.com