ODE Pharma™ is a pioneering biotechnology company at the forefront of developing innovative treatments for respiratory and pulmonary disorders. By harnessing the power of the body’s natural systems, specifically the gut microbiome and mitochondria, we are driving advancements in healthcare and improving patient outcomes.
ODE Pharma is currently developing ODE-001™ that potentially enables cell restoration and regeneration, strengthens cells and reduces inflammation.
By providing a required biochemical component to the cells’ powerhouses, and augmenting regulatory programs, ODE-001™ renews and allows organs to survive longer and pass the organs’ failure breaking point.
Cystic Fibrosis (CF) is a genetic disorder that primarily affects the respiratory and digestive systems. Caused by mutations in the CFTR gene.
This condition leads to the production of thick and sticky mucus, clogging airways and causing respiratory complications. CF patients often experience chronic lung infections, diculty in breathing, and malnutrition due to impaired digestion.
The consequences of CF can be severe, impacting both quality and length of life. While advancements in treatment and care have improved the prognosis and life expectancy for many patients, the quality of life of CF patients remains impaired.
ODE-001™ is a promising potential treatment for Cystic Fibrosis patients
Promising pre-clinical outcomes and certain mechanisms of action, coupled with clinical data across various indications, positions ODE-001™ as a molecule that may improve the compromised quality of life of CF patients and may potentially delay disease progression.
ODE-001 can be co-administered alongside bronchodilators, antibiotics and/or with Gene Therapy to restore the CFTR proteins.
Recognized as an orphan disease characterized by a significant unmet medical need, CF positions ODE-001 for an expedited regulatory market approval.
An Orphan Disease Designation (ODD) ensures a distinctive status, allowing for 7 years of market exclusivity in the United States and 10 years market exclusivity within the European Union, due to the high priority and unmet need.
In addition, as a disease of pediatric population, an additional 6 months of market exclusivity is granted upon performance of clinical trials in these patients.
FDA & EMA regulatory Market Exclusivity following patent expiration.
Proof-of-Concept clinical trial in COVID-19, demonstrating the therapeutic potential and efficacy.
Conducted comprehensive in vitro and in vivo studies on ODE-001 mechanism of action.
Successfully produced a clinical trial batch of ODE-001, obtaining three-year stability testing approval.
Intellectual property (IP) registration has progressed to the Patent Cooperation Treaty (PCT) stage.
Sepsis, Acute Respiratory Distress Syndrome (ARDS), Idiopathic Pulmonary Fibrosis IPF) / Interstitial Lung Disease (ILD), Influenza.
CF Gut Implications, Inflammatory Bowel Disease, Gut Dysbiosis
Chronic Graft Versus Host Disease
Co-founder
Nobel Prize winner is Chemistry
Former Vice President; Head of Global Clinical Development, Chief Clinical Officer at Teva Pharmaceuticals
Business Development
Immunology and Cancer Researcher
Senior pediatric pulmonologist, Focus on Cystic fibrosis in children
Business Development
Director of Hadassah’s Institute of Pulmonology and Head of the Adult and Invasive Pulmonology Unit
Former Director of the Bone Marrow Transplantation and Cancer Immunology Department at Hadassah Medical Center
Head of R&D