The Agency agreed to the biological rationale of the allergy prevention concept and endorses the proposed key elements of the clinical safety and efficacy studies including study population, duration, and endpoints.
"We are very pleased to get this favourable opinion from EMA’s medical experts”, says Marion Kauth, CEO and co-founder of Protectimmun. "It is the reward for our efforts to elaborate the complete development plan for this first-in-class innovation at the earliest and to carefully consider the special issues for a preventive approach in children.”
Nose drops for the prevention of hay fever and asthma
Protectimmun is a pharmaceutical R&D company focussed on new approaches in the prevention and therapy of allergic and chronic inflammatory diseases. Its lead development is a first-in-class medicinal product that may offer long-lasting protection against the development of hay fever and allergic asthma in infants. The product contains probiotic bacteria from a specific farm environment and will be applied as nose drops. Application via the nasal mucosa mimics the natural exposure of farm children by intensive barn contact in early life that has been shown to be allergy-protective in large epidemiological studies. More than 5 million infants would be eligible for this preventive treatment in Europe and the USA each year.
Professor Albrecht Bufe, paediatrician and co-founder of the company, comments: „Allergic airway diseases have been steadily increasing over the last 60 years and treatment options are so far quite limited. Therefore, a safe and effective primary prophylaxis is a significant unmet medical need. Nowadays, every child in Europe and North America has a 20% risk of developing allergic airway disease and this risk increases up to 70% for children of allergic parents.”
Broad proof-of-concept has been established in relevant animal models and pre-clinical toxicity and safety testing has successfully been completed so that the project is prepared to enter the clinical Phase. “Having met this milestone we are looking forward to discuss the project with investors and established companies for partnering to expedite the clinical development”, states Marion Kauth.