("Galimedix"), a Phase 2 clinical-stage biotechnology company developing novel oral and topical neuroprotective therapies with the potential to revolutionize the treatment of serious eye and brain diseases, today announced the appointment of Luciana Summo, PhD, as Vice President, R&D Operations. In this newly created position, she will oversee all activities related to R&D operations, with an emphasis on clinical development and operations. This includes spearheading the design, planning, and execution of clinical trials. Dr. Summo reports to Hermann Russ, MD, PhD, Co-founder and Chief Scientific Officer.
"We are delighted to welcome Luciana to Galimedix," said Alexander Gebauer, MD, PhD, Co-founder and Executive Chairman. "She brings strong experience setting up and running clinical trials and ensuring that all of the proper support structures are put in place. As we move our lead product candidate, GAL-101, into Phase 2 testing for the treatment of dry age-related macular degeneration, her skill set is the perfect fit for this next stage in our development. Luciana will play a pivotal role in defining Galimedix's overall R&D strategy and driving our R&D initiatives forward. All of us very much look forward to working with her as we contribute to advancing innovative healthcare solutions that have the potential to improve the lives of patients."
Dr. Summo has over 20 years of experience in clinical development and operations, including the management of Phase 1-2 clinical trials in several indications such as ophthalmology, cardiology, and oncology. Prior to joining Galimedix, she worked in positions of increasing responsibility in the clinical departments at OMEICOS Therapeutics GmbH, NOXXON Pharma AG, and Berlin-Chemie AG/ Menarini Group. She is well versed in setting up and overseeing clinical trials on a global scale and has played a key role in transitioning programs from pre-clinical to clinical stage. She has experience with the entire spectrum of activities related to R&D operations, with a special emphasis on clinical development and clinical operations, including also quality management and CMC. She works closely with cross-functional teams, including CROs, scientists, clinicians, regulatory affairs specialists, and different stakeholders, to ensure that trials are conducted in accordance with rigorous scientific standards and regulatory guidelines. Dr. Summo has experience in submitting Clinical Trial Applications (CTAs) in Europe and Investigational New Drug (IND) applications in the US and prepared for and participated in pre-IND meetings with the US Food and Drug Administration (FDA), as well as regulatory agency meetings in Europe. She also has set up from scratch and run a clinical operations department.
Luciana Summo, PhD, Vice President, R&D Operations, added: "I am truly excited to be joining Galimedix at this important point in the Company's growth. The programs in ophthalmology and Alzheimer's disease have the potential to change the treatment paradigm, and I look forward to working with the rest of the team to bring them forward in the clinic."
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About Galimedix Therapeutics, Inc.
Galimedix is a Phase 2 clinical-stage private company developing novel oral and topical neuroprotective therapies with the potential to revolutionize the treatment of serious eye and brain diseases. Founded by a seasoned and highly dedicated team of bio-entrepreneurs, pharmaceutical executives and scientists, Galimedix's groundbreaking small molecules offer the hope of changing the course of disease where amyloid beta (Aβ) plays a role, such as in dry age-related macular degeneration (AMD), glaucoma and Alzheimer's disease - Galimedix's initial areas of focus. The Company's approach targets toxic Aβ oligomers and protofibrils. Many studies have indicated that these oligomers and protofibrils are an underlying cause of neurodegenerative diseases of the eye. And, recent approvals and promising Phase 3 results of anti-Aβ drugs also have validated them as a key target in Alzheimer's disease. Compelling pre-clinical data support the potential of Galimedix's product candidates to slow or stop neurodegeneration and also restore lost neuronal function. A Phase 2 proof-of-concept study in dry AMD with lead program, topical GAL-101, is in preparation with strong support from partner, Théa Open Innovation (TOI). Clinical studies in other indications are planned.
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