Protectimmun Gets Positive Scientific Advice Response from EMA for Innovative Allergy Prophylaxis
Protectimmun GmbH has successfully discussed the overall clinical development plan for its innovative allergy prophylaxis against hay fever and allergic asthma in a Scientific Advice Meeting with the European Medicines Agency (EMA). 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 US each year.
Professor Albrecht Bufe, paediatrician and co-founder of the company, comments: "Allergic airway diseases have been steadily increasing during 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 preclinical 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.
Related News
-
News Patients vs Pharma – who will the Inflation Reduction Act affect the most?
The Inflation Reduction Act brought in by the Biden administration in 2022 aims to give better and more equitable access to healthcare in the USA. However, pharma companies are now concerned about the other potential costs of such legislation. -
News CPHI Podcast Series: What does the changing US Pharma market mean for industry and patients alike?
In this week's episode of the CPHI Podcast Series Lucy Chard, Digital Editor for CPHI Online is joined by James Manser to discuss the political and market changes in the US pharma field. -
News CPHI Barcelona Annual Report illuminates industry trends for 2024
The CPHI Annual Survey comes into it’s 7th year to report on the predicted trends for 2024. Over 250 pharma executives were asked 35 questions, with their answers informing the industry landscape for the next year, spanning all major pharma marke... -
News Which 10 drugs are open to price negotiation with Medicare in the USA?
The Centres for Medicare & Medicaid Services, under the Biden administration in the USA, has released a list of the 10 drugs that will be open to price negotiations as part of the new legislation under the Inflation Reduction Act (IRA). -
News EU Medical Devices Regulation causes unintended disappearances of medical devices for children, doctors state
Doctor groups and associations have appealed to the EU to correct the EU Medical Devices Regulation law that may cause unintended shortages of essential drug and medical devices for children and rare disease patients. -
News 10 Major Drug Approvals So Far in 2023
Last year, 37 novel drugs were approved by the FDA, this was a high number for such a category, and covered many fields including oncology, demonstrating how promising further research is, and how it is only continuing to build. To date, there are alre... -
News Detecting Alzheimer's disease with a simple lateral flow test
A novel rapid diagnostic test for early-stage Alzheimer's disease has been developed using a biomarker binder from Aptamer Group along with technology from Neuro-Bio, the neurodegenerative disease experts. -
News CPHI Podcast Series: outsourcing and manufacturing trends
Listen to the CPHI Podcast Series this June to hear Gil Roth of the PBOA speak with Digital Editor Lucy Chard about the biggest trends and topics to watch in pharma outsourcing and manufacturing at the minute.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance