LB Pharmaceuticals Presents Results of Dopamine Receptor Occupancy Studies of LB-102 at ECNP Conference

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LBs presentation included results from PET studies designed to evaluate striatal dopamine receptor occupancy (RO) in mice and in healthy human subjects.

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Monday, October 4, 2021
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Research, Technology, Other Technology, Clinical Trials, Biotechnology, General Health, Pharmaceutical, Health, Science, Other Science, CNS, Mouse, PET, European College of Neuropsychopharmacology, Amisulpride, RO, Pharmacokinetics, ECNP, Patient, CEO, Trial of the century, Human, Brain, Safety, Intellectual property, Schizophrenia, Pharmaceutical industry
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NEW YORK, Europe, United States, PORTUGAL, US, LISBON
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LB PHARMACEUTICALS
Summary
Key Points: 
  • LBs presentation included results from PET studies designed to evaluate striatal dopamine receptor occupancy (RO) in mice and in healthy human subjects.
  • In mice, dopamine RO of LB-102 was double that of amisulpride at the same dose.
  • Doses used in this study were a fraction of published doses of amisulpride required to reach a similar dopamine RO.
  • We believe that results from these PET studies establishes proof of concept that LB-102 will be an effective treatment for schizophrenia.


LB Pharmaceuticals Inc, (“LB”) a biotechnology company focused on developing and commercializing novel and improved versions of successful CNS treatments, announced today that results of PET studies of its lead compound to treat schizophrenia, LB-102, have been presented at the European College of Neuropsychopharmacology (ECNP) 2021 conference, held in Lisbon, Portugal.

The presentation, titled “LB-102 displays superior dopamine receptor occupancy compared to amisulpride in mouse and human positron emission tomography (PET) studies,” was presented at the ECNP by Andrew Vaino, Ph.D., the Company’s Chief Scientific Officer, on Monday, October 4, 2021.

LB’s presentation included results from PET studies designed to evaluate striatal dopamine receptor occupancy (RO) in mice and in healthy human subjects. In mice, dopamine RO of LB-102 was double that of amisulpride at the same dose. In humans LB-102 demonstrated striatal dopamine RO in the desired 60% to 75% range with single doses between 50 mg and 100 mg LB-102, doses that were well-tolerated in an earlier Phase 1 clinical study. Receptor occupancy was unexpectedly persistent, with RO > 50% out to 48 hours post-dose. Doses used in this study were a fraction of published doses of amisulpride required to reach a similar dopamine RO.

“These data strongly support our thesis that LB-102 will be an effective antipsychotic with lower and less frequent doses than those typically used for amisulpride,” said Dr. Vaino. “We were surprised how long after dosing LB-102 engaged its target in the brain, which we attribute to slow equilibration of LB-102 from the brain into the periphery.”

Zachary Prensky, President and CEO, added “LB-102 has consistently exceeded expectations in every phase of its development to date, including our first two clinical studies. We believe that results from these PET studies establishes proof of concept that LB-102 will be an effective treatment for schizophrenia.” A Phase 2 clinical study of LB-102 in schizophrenia patients is expected to begin in early 2022.”

A copy of the abstract will be available on the Company’s website at following the presentation at www.LBPharma.us.

About LB Pharmaceuticals

LB is a development stage CNS-focused life science company devoted to commercializing novel and improved versions of successful CNS treatments used extensively overseas but never developed, approved, or marketed, in the United States. Our approach is to create a research-focused organization dedicated to generating novel intellectual property around improved versions of these former best-selling drugs. We have a low-risk, high-reward drug development business plan: Invest in bringing to the US market patented, branded, first-to-market versions of standard-of-care CNS therapies currently in use worldwide.

LB’s lead compound, LB-102, or N-methyl amisulpride, is a patented derivative of amisulpride, a dopamine/5-HT7 antagonist successfully used to treat schizophrenia in Europe for decades. LB-102 has the potential to offer schizophrenia patients the benefits of amisulpride at a lower dose than amisulpride. A first-in-human, double-blind placebo-controlled, Phase 1 clinical of LB-102 study designed to test the safety and pharmacokinetics of LB-102 was in 2020, and a second clinical study evaluating dopamine receptor occupancy of LB-102 in healthy volunteers was completed in September 2021. A Phase 2 clinical trial in acute schizophrenia patients is expected to begin in early 2022.

More information about LB-102 and LB Pharmaceuticals may be found on our corporate website located at www.LBPharma.us

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