Pre-IND meeting related to Phase 2b SPRING trial completed with US FDA
World-class clinical advisory board to support clinical development plans
SAN FRANCISCO, May 10, 2023 /PRNewswire/ -- Lighthouse Pharmaceuticals, a clinical-stage pharmaceutical company developing therapeutics to alter the course of dementia and other degenerative diseases, announced completion of a Pre-investigational New Drug (PIND) meeting with the Food and Drug Administration (FDA) related to the planned Phase 2b clinical study of LHP588 and the formation of its Clinical Advisory Board (CAB). The CAB includes six members with diverse backgrounds and expertise in dementia, Alzheimer's disease, inflammation, neurodegenerative disorders, and drug development: Marwan Sabbagh, M.D., Merce Boada, M.D., Jeffrey Cummings, M.D., Clive Holmes, M.D., Mark Ryder, D.M.D., and Lon Schneider, M.D.
"We are thrilled to have attracted world-leading experts to support Lighthouse Pharma as we develop our lead compound, LHP588, an orally bioavailable small molecule, which represents a new paradigm for potential disease modification in dementia," commented Michael Detke, M.D., Ph.D., co-founder and Chief Medical Officer of Lighthouse Pharma. "Clinical studies of the first-generation molecule have de-risked and informed our path forward with LHP588."
"The excellent clinical safety of LHP588, paired with the learnings from previous late-stage clinical studies enables Lighthouse to move quickly into key clinical studies to further validate this treatment paradigm," said Marwan Sabbagh, M.D., Behavioral Neurologist and Chair of Lighthouse Pharma's Clinical Advisory Board. "I look forward to working with the company on the upcoming Phase 2b study and bringing this innovative treatment to patients."
"We appreciate the FDA feedback on the development program which has helped to inform a clear path to start the Phase 2b study. The membership of our Clinical Advisory Board speaks to the scientific and clinical enthusiasm for Lighthouse Pharma's unique therapeutic approach to dementia treatment, and to the potential of LHP588 in particular," said Casey Lynch, co-founder and Chief Executive Officer of Lighthouse Pharma. "We are grateful for the FDA and the Board for their contributions as we work to quickly advance this novel precision treatment for patients suffering from Alzheimer's disease."
Lighthouse Pharma's Clinical Advisory Board Members:
Chairman: Marwan Sabbagh, M.D., is a behavioral neurologist and professor at Barrow Neurological Institute and is a board-certified neurologist and dementia expert. Dr. Sabbagh was previously director of the Cleveland Clinic Lou Ruvo Center. He is a leading investigator for many prominent national Alzheimer's prevention and treatment trials. He has authored and co-authored more than 400 medical and scientific articles on Alzheimer's research.
Merce Boada, M.D., is a neurologist and co-founder of the ACE Foundation (Alzheimer Educational Centre) which is a leader in research and care for people with Alzheimer's and other dementias. She is a member of the Executive Committee of the European Alzheimer's Disease Consortium (EADC) and founder and member of the Scientific Committee of the Mediterranean Alzheimer Alliance (MAA). She has published over 280 scientific articles and has participated in over 105 clinical trials.
Jeffrey Cummings, M.D., Sc.D., is a longtime Alzheimer's researcher and clinical trial leader committed to developing new therapies for diseases of the brain and understanding the interface of neuroscience and society. Dr. Cummings is Research Professor in the Department of Brain Health at University of Nevada Las Vegas where he directs the Chambers-Grundy Center for Transformative Neuroscience. He is the founding director of Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas, Nevada and the founding director of the Mary S. Easton Center for Alzheimer's Disease Research at UCLA.
Clive Holmes, M.D., is Professor Emeritus of Biological Psychiatry at the University of Southampton, UK, with a focus on research on the biological factors that alter the clinical course of Alzheimer's Disease and other chronic neurodegenerative conditions, with a focus on the role of inflammation. Professor Holmes also leads a clinical trials unit that examines the effects of pharmacological interventions of patients with Alzheimer's disease and related conditions. He is an honorary consultant in Old Age Psychiatry at Southern Health Foundation Trust.
Mark Ryder, D.M.D., a bacterial infection, inflammation, and disease specialist, is Professor and Chair of Periodontology at the University of California, San Francisco (UCSF), where he has been a faculty member for 43 years. He has served as the PI, Co-PI, Co-Investigator, and/or examiner for many government- and industry-sponsored clinical studies related to infection and disease.
Lon Schneider, M.D., M.S., is professor of Psychiatry, Neurology, and Gerontology at the Keck School of Medicine of the University of Southern California. He also serves as director of the California Alzheimer's Disease Center, the Geriatric Studies Center, and as co-director of the clinical core of the USC's NIH Alzheimer's Disease Research Center.
About Lighthouse Pharmaceuticals
Lighthouse Pharma is a clinical stage private biopharmaceutical company pioneering precision medicine approaches to major unmet medical needs based on expertise in small-molecule protease inhibition. Lighthouse's lead program, LHP588, a Phase 2b ready orally available small molecule, targets a specific, infectious pathogen, Porphyromonas gingivalis, which is associated with chronic degenerative and inflammatory disorders including dementia, periodontal disease, atherosclerosis, and orodigestive cancers. For more information, visit .
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