New Treatments for Neurological, Psychiatric, Metabolic, Ophthalmic and Immunologic Indications
From discovery to approval
We discover and develop new treatments for neurological, psychiatric, metabolic and ophthalmic disorders, including disorders of aging and senescence. Our ongoing research is presently focused on uncompetitive NMDA receptor antagonists and serotonin receptor modulators, including their combination in formulations and dosages that provide synaptic modulation and trophic effects for neurons and their networks and metabolic and ophthalmic effects.(neuroplastogen programs).
We focus on discovering new molecules and new uses of known molecules and their isomers. We secure IP and data exclusivity. We design NCEs and test them in silico and study their SAR. We synthesize NCEs. We perform in vitro and in vivo testings. We design and monitor clinical trials, from Phase 1 to Phase 3 registration trials, in a coordinating role with global and local CROs. We actively collaborate with research facilities in EU, UK, Switzerland and in the US and we interface with FDA, EMA, PMDA and Swissmedic.
Esmethadone (REL-1017) program (Levomecor Inc.)
a) Advanced Phase 3 program for the development of esmethadone (REL-1017) as adjunctive treatment for patients with major depressive disorder and inadequate response to first line antidepressants.
b) Phase 2 clinical program for the development of esmethadone for patients with restless leg syndrome.
For all scientific literature supporting the safety and efficacy of esmethadone, please refer to:
https://www.levomecor.com/publications
Psilocybin (REL-P11) program (Arbormentis LLC)
a) Modified release psilocybin (REL-P11) and PEG-psilocin for metabolic indications, including obesity, type 2 diabetes mellitus and steatotic liver disease.
b) REL-P11 and psilocin.carbamate for visual recovery after occipital stroke.
Design of structurally modified molecules
We modify select sections of key molecules and build virtual libraries of novel drugs with NMDAR and 5-HT2A modulatory effects with potentially improved SAR for neuropsychiatric, ophthalmic, metabolic and immunologic indications
Molecular modeling and in silico testing
We build and test in silico models of specific receptor-drug interactions and obtain estimates of SAR for virtual molecules and select lead candidates
Synthesis of new chemical entities
We develop novel efficient proprietary synthetic methods and escalate synthesis for the most promising leads
Advancement of leads
Through sequential proprietary in vitro and in vivo tests we advance neuroplastogen ® molecules with neuroprotective, neuro-modulatory and immuno-modulatory actions for optimized neuropsychiatric, ophthalmic, metabolic and immunologic indications
In vitro testing
We test lead molecules for affinity and activity at select receptor targets and advance them in excitotoxicity-prevention models, in neural plasticity restorative models for synaptic enhancement and in metabolic models
In vivo testing
We confirm the in vitro results with experiments in vivo on select animal models and obtain behavioral and pathology data to detect potential efficacy, safety and PK of the lead molecules
Clinical trials
We manage clinical development from Phase 1 (safety and PK), phase 2 (proof of concept) and Phase 3 registration trials in collaboration with efficient local CROs in Switzerland, EU, US, Japan
Intellectual property
We ensure that IP and data exclusivity are preserved and upgraded all along the drug development pathway
Regulatory interface
We interface with FDA, EMA, AIFA, PMDA, and Swissmedic
Our team
Marco Gentilucci MD
President and CEO
Marco is the former President of Medeor Inc., a joint venture with Cornell Center for Technology Enterprise & Commercialization (CCTEC). Medeor then merged with Relmada Therapeutics, a publicly traded biotechnology company . Marco is experienced in drug development services aimed at novel treatments for metabolic, ophthalmic and neuropsychiatric disorders
Education
SUNY at Stony Brook: Doctor of Medicine
Albert Einstein College of Medicine. Specialized in Internal Medicine and Cardiology
Paolo Manfredi MD
Scientific Advisor
Paolo Manfred is a neurologist and esmethadone expert. Dr. Manfredi is a co-founder of Medeor Inc. a joint venture with Cornell Center for Technology Enterprise & Commercialization (CCTEC). Medeor then merged with Relmada Therapeutics, a publicly traded biotechnology company. Dr. Manfredi is a co-inventor of several pharmaceutical patents currently under development. REL-1017 (esmethadone), a well tolerated and safe oral, once-daily NMDA receptor antagonist is currently in Phase 3 for the adjunctive treatment of major depressive disorders. REL-P11 (MR psilocybin) has successfully completed a SAD Phase 1 study in overweight-obese subjects and in normal BMI subjects and is Phase 2 ready
Education
University of Genova, Italy: Doctor of Medicine
Albert Einstein College of Medicine, Montefiore Hospital; University of Texas, MD Anderson Cancer Center; Harvard Medical School, Massachusetts General Hospital. Specialized in Neurology and Psychiatry and Pain Management
Marco Pappagallo MD
Scientific Advisor
Marco Pappagallo is a Neurologist and Clinical Professor of Neurology and Anesthesiology at Albert Einstein College of Medicine, New York. Marco is an internationally renowned researcher and lecturer with over 100 publications and a seasoned inventor of pharmaceuticals. Marco has conducted (PI) clinical trials sponsored by NIH, Glaxo, Roche, and Pfizer and has held CMO positions in several biotechnology companies, including Relmada Therapeutics. Marco is a co-inventor on the psilocybin platform, which includes REL-P11, a Phase 2-ready molecule
Education
University La Sapienza, Rome Italy: Doctor of Medicine
SUNY at Stony Brook; John’s Hopkins School of Medicine. Specialized in Neurology and Psychiatry, Neurosurgery and Pain Management
Andrea Alimonti MD PhD
Scientific Advisor
Andrea Alimonti, Head of Molecular Oncology and Director of the Institute of Oncology Research and Professor of Oncology at the Universita’ della Svizzera Italiana is an ERC and J Steiner Cancer Research awarded scientist. Dr Alimonti is author of several groundbreaking publications in major scientific journals: Nature, Cell, Nat. Gen. among others. Andrea has discovered a novel pro-senescence approach to cancer therapy based on the enhancement of cellular senescence and tumor immune response. Andrea is a co-inventor on the psilocybin platform, which includes REL-P11, among other molecules
Education
University of Rome, La Sapienza, Italy: Doctor of Medicine
Harvard medical School; Memorial Sloan Kettering Cancer Center. Specialized in Oncology
Maurizio Corbetta MD
Scientific Advisor
Maurizio Corbetta is Chair and Professor of Neurology at the University of Padova and Director of Padova Neuroscience Center (PNC). Maurizio is an internationally renown researcher, winner of several awards and author of over 300 publications in the field of neuroscience and neurology. The main focus of his research is to understand how different regions in the brain interact and exchange information to mediate behavior in health and neurological disorders. His laboratory focuses on three main topics: Attention Networks; Electrophysiology and Function of Intrinsic Activity; and, Neurological Mechanisms of Recovery
Education
University oof Pavia: Doctor of Medicine; University of Verona; Washington University School of Medicine; Specialized in Neurology and Psychiatry
Franco Folli MD PhD
Scientific Advisor
Franco Folli is a Professor of Endocrinology and Metabolism at the University of Milano, School of Medicine and previously a tenured professor of Medicine at the University of Texas Health Science Center in San Antonio, Texas. Franco is an internationally recognized physician scientist with over 200 publications on the pathogenesis, diagnosis and treatment of diabetes mellitus and its complications in the New England Journal of Medicine, Nature, Cell Stem Cell, Journal of Clinical Investigation, PNAS, Diabetes Care and Diabetes, among others. Franco has conducted NIH sponsored research studies (PI) as well as clinical trials sponsored by Takeda and Amylin. He is an inventor of methods for the diagnosis of Type 1 diabetes and Stiff Person Syndrome and treatment of Type 2 diabetes. Franco is a co-inventor on the psilocybin platform, which includes REL-P11, among other molecules
Education
University of Milano, Doctor of Medicine; University of Milano and Padova (joint program), PhD
Middlesex University Hospital, London, UK; Yale University School of Medicine, Department of Cell Biology, Harvard Medical School, Joslin Diabetes Center. Specialized in Diabetes and Metabolic Diseases.
Charles Inturrisi PhD
Scientific Advisor
Charles E. Inturrisi, PhD, is Emeritus Professor of Pharmacology and Professor of Neuroscience at Cornell University. Dr. Inturrisi served as the 2008-2010 American Pain Society President. Dr. Inturrisi has researched the role of glutamate receptors in neuropsychiatric diseases and pain. Dr. Inturrisi is a co-inventor of several pharmaceutical patents currently under development. REL-1017 (esmethadone), a well tolerated and safe oral, once daily NMDA receptor antagonist is currently in Phase 3 for the adjunctive treatment of major depressive disorders . Chuck is a co-inventor on the psilocybin platform, which includes REL-P11, among other molecules
Education
Cornell University: PhD
Maurizio Rolando MD
Scientific Advisor
Maurizio Rolando is an internationally renown expert of diseases of the anterior segment of the eye and the author of over 400 publications in the field of ophthalmology. Professor Rolando has served as a consultant in ophthalmology drug development programs for Alcon, Allergan, Bausch & Lomb, Farmigea, Medivis, Pfizer, Sifi, Thea, TRB Chemedica, Santen.
Education
University of Genova, Italy: Doctor of Medicine
Schepens Eye Research Institute, Boston; Massachusetts Eye and Ear Infirmary-Harvard Medical School
Giovanni Giordano MD
Scientific Advisor
Giovanni Giordano is an expert in the prevention and treatment of diseases of the retina, including macular degeneration.His research focus has been centered around the formulation of controlled release drugs for intravitreal administration. Giovanni is a co-inventor on the psilocybin platform, which includes REL-P11, among other molecules
Education
University of Genova, Italy: Doctor of Medicine
Schepens Eye Research Institute, Boston; Massachusetts Eye and Ear Infirmary-Harvard Medical School; University of Texas; Rice University
Gianfranco Pasut PhD
Scientific Advisor
Gianfranco Pasut is a Full Professor of Pharmaceutical Technology at the Department of Pharmaceutical and Pharmacological Sciences at the University of Padova, Italy. Professor Pasut specializes in drug and protein delivery, particularly through polymer conjugation. His pioneering work includes the development of various polymer conjugation methods to proteins, and he has established successful collaborations with several industry partners. Presently, within his research laboratory, he explores novel approaches to polymer conjugation, Antibody Drug Conjugates (ADCs), and targeted liposomes. Notably, he has significantly contributed to the advancement of using the enzyme transglutaminase in developing innovative conjugates.Professor Pasut is authorship of over 90 publications, 14 book chapters, and the inventor of 15 patents. He actively participates in scientific advisory boards for private pharmaceutical companies.Professor Pasut holds the position of Specialty Chief Editor of "Frontiers in Medical Technology | Nano-Based Drug Delivery" and serves as an Associate Editor for "Heliyon | Pharmaceutical Science
Education
University of Padova: Doctor of Pharmaceutical Chemistry and Technology; PhD in Pharmaceutical Sciences. University of Pennsylvania: Visiting Researcher
Sara De Martin PhD
Scientific Advisor
Sara De Martin is an associate professor of Pharmacology at the Department of Pharmaceutical and Pharmacological Sciences at the University of Padova, Italy. Her main research interests is hepatic pharmacology, mainly focusing on the preclinical research and development of candidate drugs for different liver diseases, including metabolic associated steatotic liver disease (MASLD) and hepatocellular carcinoma (HCC). She is a member of the Ethics Committee for Animal Studies of the University of Padova and the National Committee for the Protection of Laboratory Animals (CNPA). Sara is a co-inventor on the esmethadone platform, which includes REL-P11 and on the psilocybin platform, which includes REL-P11, among other molecules
Education
University of Padova, Master Degree in Pharmaceutical Chemistry and Technology. University of Padova and Medical University of Innsbruck, International PhD in Molecular and Cellular Pharmacology
Andrea Mattarei PhD
Scientific Advisor
Andrea Mattarei, PhD, is Associate Professor of Medicinal Chemistry at the University of Padua, Italy, leading, since 2017, the Medicinal Chemistry & Chemical Biology Lab at the Department of Pharmaceutical and Pharmacological Sciences. His research activity focuses on the design, synthesis and application of new chemical entities for pharmacological and biomedical applications. Dr. Mattarei is author of over 70 original journal articles in these fields, contributing to the scientific development of articulate projects in which chemistry intersects with pharmacology, biochemistry, and cell biology. Andrea is a co-inventor on the esmethadone platform, which includes REL-P11 and on the psilocybin platform, which includes REL-P11, among other molecules
Education
University of Padova, Italy: Master's degree, Industrial Chemistry; PhD in Molecular Sciences. University of Illinois, Chicago, US: Visiting Researcher; research group of Prof. Alan P. Kozikowski. University of Regenburg, Germany: Visiting Researcher; research group of Prof. Sabine Amslinger; Italian National Research Council, Neuroscience Institute: Short Term Researcher.
Stefano Comai PhD
Scientific Advisor
Dr. Comai is Associate Professor of Pharmacology at the University of Padua, Pauda, Italy, Adjunct Professor at the Department of Psychiatry, McGill University, Montreal, Canada, and Researcher at the San Raffaele Hospital, Milan, Italy. Dr. Comai is interested in understanding the mechanisms and potential treatments of mental disorders. Dr. Comai has received several awards, including the “2015 New Investigator Award” by the American Society of Clinical Psychopharmacology, and the 2017 NARSAD Young Investigator Award by the Brain and Behavior Foundation. He serves in several committees of international scientific societies including the International Society for Tryptophan Research (ISTRY), the American Society of Clinical Psychopharmacology (ASCP) and the International College of Neuropsychopharmacology (CINP). He is also Associate Editor of Frontiers in Pharmacology, section Neuropharmacology, Medicina and BMC Psychiatry, and member of the editorial board of the Journal of Pineal Research. He is author of over 90 original articles. Dr. Comai is Head of the Translational Neuropsychopharmacology Lab of the Padua Department of Pharmaceutical and Pharmacological Sciences. Stefano is a co-inventor on the esmethadone platform, which includes REL-P11 and on the psilocybin platform, which includes REL-P11, among other molecules
Education
PhD and Post-doctoral Fellow, University of Padua, Dept. of Pharmaceutical Sciences; McGill University, Montreal, Canada, Dept of Psychiatry
George Garibaldi MD
Scientific Advisor
Dr George Garibaldi is co-founder and President Research and Development of Noema Pharma AG. He had previously progressive leadership responsibilities in research and development across multiple major pharmaceutical companies. Most recently he served as VP global head of CNS at F. Hoffmann-La Roche.Dr Garibaldi trained in child psychiatry, statistics, and neuropsychopharmacology. During his tenure at Roche, he led the development of multiple therapies including OCREVUS ® (ocrelizumab), approved in 2017 for Primary progressive and relapsing-remitting multiple sclerosis. Prior to Roche, he was Head of Psychiatry and Geriatric Psychiatry at Novartis and Neuroscience Therapeutic Area Lead at Janssen Pharmaceuticals. Throughout his career, Dr Garibaldi developed therapies for multiple conditions including Exelon® (rivastigmine) in Alzheimer’s disease, Fanapt® (iloperidone) in schizophrenia, Risperdal Consta® (risperidone long-acting injectable) in frequently relapsing patients with bipolar disorders, Invega® (paliperidone) in patients with schizoaffective disorder and lead the regulatory submission and approval of Risperdal® (risperidone) in autism spectrum disorders.Dr Garibaldi serves as peer reviewer for multiple scientific and medical journals. He authored more than 100 articles in peer reviewed journals.Dr Garibaldi is a board member of several biotechs and serves on the scientific advisory boards of many companies.
Education
University of medicine of Cairo University. He completed his residency in Child and General Psychiatry at the Rene Descartes Medical School, his studies in statistics and mathematical modeling at the University of Kremlin-Bicêtre, and his studies in Neuropsychopharmacology at the Pitié Salpétrière.
Kenneth Cusi MD
Scientific Advisor
Dr. Cusi is a Professor of Medicine at the Division of Endocrinology, Diabetes and Metabolism at The University of Florida at Gainesville at Gainesville, FL (2011-present). His early career was at the University of San Antonio Health Science Center, Texas (1992-2011), initially on the role of defects in insulin secretion and of insulin resistance in the development of T2DM to later focused on the role of metabolic dysfunction- associated steatotic liver disease (MASLD; formerly NAFLD) as a common complication needing the same degree of awareness and early intervention as retinopathy and nephropathy, or as cardiovascular disease, in individuals with type 2 diabetes. Dr. Cusi has published more than 250 peer-reviewed original manuscripts, reviews, book chapters and editorials in the fields of obesity, type 2 diabetes and NAFLD. He has contributed to several guidelines in NAFLD (AASLD 2012/2018/2023, ALEH 2020, AGA 2021, AACE 2022, ADA 2023-24). His basic and clinical research programs at the University of Florida include funding from the National Institute of Health and from industry, with a focus on the mechanisms leading to NASH and search for new treatments. He received from The University of Florida the prestigious Exemplary Teacher Award, as well as the Clinical Research Award for Outstanding Achievement, Research Discovery, and Productivity. In 2020, he received the American Association of Clinical Endocrinologists (AACE) Jack Baskin, MD, Endocrine Teaching Award.
Education
University of Buenos Aires, School of Medicine, Argentina (Doctor of Medicine); Center of Medical Education and Clinical Research (CEMIC), Buenos Aires, Argentina (internal medicine residency); Baylor College of Medicine, Houston Texas, USA (fellowship in endocrinology, diabetes and metabolism).
Massimo Apicella MD
Scientific Advisor
Massimo Apicella is a clinician and researcher in the field of child and adolescent psychiatry. After earning his MD in 2016, he began his early career in prenatal diagnosis and teratology at the Teratology Information Service of Policlinico Universitario Agostino Gemelli, Rome, a leading clinical and research center in Italy. During this period, he developed a strong interest in the early determinants of neurodevelopmental disorders and mental health, as well as in clinical pharmaceutical research, particularly in the areas of personalized therapeutic approaches and special populations. He completed his specialist training in child neuropsychiatry in 2021 and currently works at the Children and Adolescent Psychiatry Unit of Ospedale Pediatrico Bambino Gesù IRCCS, one of the largest pediatric hospital in Europe and a prominent research center in pediatrics. His work encompasses both outpatient and inpatient care, where he treats children and adolescents with affective, psychotic, or conduct disorders, also managing urgent psychiatric cases in emergency settings. His primary research interests include mood disorders and suicide, with a special focus on pediatric bipolar disorder, depression, and personalized medicine. He is also deeply interested in the early neurodevelopmental determinants of severe juvenile-onset psychopathology and has participated as a rater in clinical trials within the field of adolescent psychiatry.
Education
Università Cattolica del Sacro Cuore, Rome - PhD Student in Neuroscience ;Università Cattolica del Sacro Cuore, Rome - Specialist in Child and Adolescent Neuropsychiatry, with honors; Università Cattolica del Sacro Cuore, Rome - Medical Degree, with honors
Alessio Pigazzi MD PhD
Scientific Advisor
Dr. Alessio Pigazzi is Chief of Colorectal Surgery at NewYork-Presbyterian/Weill Cornell Medical Center and Weill Cornell Medicine. He also serves on Weill Cornell Medicine’s faculty. Dr. Pigazzi was previously chief of the Divisions of Colorectal Surgery and Surgical Oncology at the University of California, Irvine (UCI), where he also served as professor in the Department of Surgery and vice chair for research. Dr. Pigazzi’s clinical expertise focuses on the treatment of complex colon, rectal and anal conditions and cancers, including laparoscopic, robot-assisted and open surgical techniques. He performed the world’s firs robot-assisted resection for rectal cancer in 2004, a procedure that has revolutionized the treatment of this condition. He has an active research program focused on the relationship between diet, the metabolic syndrome and colorectal cancer development. He is also interested in studying ways to improve recovery after cancer surgery and during postoperative chemotherapy. He is also leading clinical research programs combining surgery with immediate postoperative chemotherapy to improve cancer survival. Dr. Pigazzi is a fellow of the American College of Surgeons and the American Society of Colon and Rectal Surgeons; a member of the Society of Surgical Oncology; and a founding member of the Clinical Robotic Surgery Association.
Education
Boston University School of Medicine, and completed his internship and residency in general surgery at NewYork-Presbyterian/Weill Cornell Medical Center. He completed a fellowship in minimally invasive surgery at Hackensack Medical Center in Hackensack, N.J., and a fellowship in colorectal surgery at UCI Medical Center.
Giulia Serra MD PhD
Scientific Advisor
Giulia Serra, MD, PhD is an experienced researcher in the field of Bipolar Disorder (BD) and author of 50+ publications in international peer-review journals. As a psychiatrist, she was trained by mood-disorder world expert Dr. Athanasios Koukopoulos. In 2013-14, was trained in conducting research in pediatric BD at the Pediatric Psychopharmacology Program of Massachusetts General Hospital (Harvard Medical School, HMS) in collaboration with leading experts Drs. J. Wozniak & J. Biederman. In 2013–16 she has been a Post-doctoral Research Fellow at the Dept. of Psychiatry of McLean Hospital (HMS) working with Prof. Ross Baldessarini. Her research and clinical activities have focused on the developmental course of BD from childhood to the adult age and on the use of experimental mood stabilizing treatment for BD. She was the PI of several projects seeking to quantify precursors, risk factors and the developmental course of juvenile mood disorders, including clinical predictors of diagnosis, long-term morbidity and suicidal behaviors in major affective disorders. Her pharmacological research focuses on the experimental use of memantine to test its preliminarily observed mood stabilizing effects in adult BD. In 2010-15, she worked on the first pilot clinical study on memantine to augment standard treatments in adult, treatment-resistant, BD patients. This work has led to several peer-reviewed publications and book chapters with very encouraging indications of large and sustained improvements in the duration and severity of both depressive and manic phases of BD. Since 2015 she joined the Child and Adolescent Neuropsychiatry Unit at the Bambino Gesù Pediatric Hospital where she works as a Consultant Psychiatrist leading the research and clinical activities of the Pediatric Mood Disorder Program admitting ~1200 day hospital/year. From 2020 she is the PI of no profit randomized, double-blind, placebo-controlled clinical trial on the efficacy and safety of memantine as anti-manic and mood-stabilizing medication for children and adolescents with Bipolar Disorder funded by the Italian Ministry of Health
Education
Giulia Serra obtained the MD degree from the University of Cagliari in 2008 with highest honors and completed the five-year Residency Program in Psychiatry at Sapienza University of Rome in 2015.
Clotilde Guidetti MD
Scientific Advisor
Clotilde Guidetti is a child and adolescence neuropsychiatrist with additional expertise in MDD clinical trials.
Education
University of Genova, Italy: Doctor of Medicine Child and Adolescent Neuropsychiatrist, Department of Neuroscience, IRCCS Bambino Gesù Pediatric Hospital
Research Fellow, Clinical Trial Unit, Massachusetts General Hospital, Harvard University
Carlo Rupnik
Head of Legal Logistics and Management Advisor
Carlo Rupnik is a consultant for technology companies. Carlo has directly managed regulatory filings in state and federal offices of over 20 countries
Education
University of Liverpool UK, Master in Business Administration
Hugo Giambarella
Head of Science Logistics
Ugo Giambarella has over 30 years experience in neuroscience research in prestigious universities in the US, Europe and Japan, including Harvard University, Boston University, Université Paris Cité, Universita` di Siena, Universita` di Padova, Keio University. Over the past 4 years Ugo has been consulting for biotech companies in logistics of global drug development.
Andrea Varalli
Head of Communications, Brand Experience and Digital Design
Andrea Varalli is a seasoned consultant for international companies in digital design and brand communication, including their technical aspects.
Chiara Sanguineti
Head of Administration
Education
University of Genoa, Degree in “Lingue e Culture Moderne per l’Impresa e il Turismo”
Bocconi University, Master in Tourism Economics and Management
Gaia Rizzo
Scientific Manager
Education
University of Rome La Sapienza, Degree in Cognitive Neuroscience
Consorzio Universitario Humanitas, advanced training course in Psychophysiology and Cognitive Neuroscience
Giacomo Manfredi Firmian
Head of Human Resources
Education
Giacomo Manfredi Firmian managed over 1000 employees for over 20 years in US and Europe as Hotel General Manager for Carnival Corporation