Synendos Therapeutics, a clinical-stage biotechnology company developing breakthrough therapies for neuropsychiatric disorders, has appointed Dr. George Garibaldi as Chief Medical Officer to lead the company's transition into Phase 2 clinical development of its lead drug candidate SYT-510. The appointment comes at a pivotal moment as the company advances its novel approach to treating neuropsychiatric and CNS disorders through endocannabinoid system modulation.
Veteran CNS Development Leader Joins Synendos
Dr. Garibaldi brings more than 30 years of experience leading global clinical development programs in CNS disorders. His career spans leadership roles at major pharmaceutical companies including Roche, Novartis, and Janssen, where he oversaw the development of breakthrough treatments including Ocrevus for primary progressive and relapsing remitting multiple sclerosis and Exelon for Alzheimer's disease and Lewi body dementia.
As co-founder of Noema Pharma, Dr. Garibaldi spearheaded the in-licensing and advancement of shelved CNS assets, securing major venture funding and progressing them through pivotal clinical trials. He has published more than 100 peer-reviewed articles and developed widely used clinician- and patient-reported outcome measures. Dr. Garibaldi is a founder and past president of the International Society for CNS Clinical Trials and Methodology.
"It's tremendous that Synendos can attract this calibre of talent and experience," said Andrea Chicca, CEO of Synendos. "George offers a nuanced clinical perspective on the urgent needs of the patients we are looking to help, combined with specific expertise in advancing transformative neuroscience therapies from concept to clinical adoption."
Novel Endocannabinoid System Approach
SYT-510 belongs to a novel class of endocannabinoid system (ECS) modulators named Selective Endocannabinoid Re-uptake Inhibitors (SERIs). These represent first-in-class, new chemical entities that modulate the ECS through a self-limiting mode of action with the potential to deliver meaningful benefits to patients targeting neuropsychiatric and other CNS disorders such as anxiety disorders, PTSD, and other indications.
The novel mechanism of action has the potential to combine treatment of a range of symptoms with sustained efficacy in large patient populations while addressing a key unmet need of chronic tolerability, potentially allowing more patients to stay on treatment and regain an improved quality of life.
Rethinking Mental Health Drug Development
Dr. Garibaldi emphasized the need for innovation in mental health therapeutics, stating, "Mental health and brain health have for far too long been underserved by traditional drug development models. Synendos is combining the pursuit of an innovative target with a commitment to rethinking how we design trials, measure outcomes and prioritize patient function."
He added, "Society today recognizes that there is no health without mental health. We have the rare opportunity to chart our own path here. I am eager to lead this transformation and help this exceptional team advance the next generation of brain therapies that could truly change the lives of patients."
The appointment positions Synendos to leverage Dr. Garibaldi's extensive experience in CNS drug development as the company advances SYT-510 through Phase 2 clinical trials, potentially offering new treatment options for patients with neuropsychiatric disorders who have been underserved by existing therapeutic approaches.
