ÎçÒ¹¾ç³¡ Develops Innovative Oral Food Challenge meals for the Paediatric food allergy population

ÎçÒ¹¾ç³¡ is excited to announce the development of its new range of Oral Food Challenge meals, designed to significantly improve the quality of life for very young children with food allergies. Committed to addressing the critical issues of food allergy diagnosis, enhancing quality of life, and reducing the economic burden of allergies, ÎçÒ¹¾ç³¡ continues to lead the way in innovative healthcare solutions.

Food allergies are increasingly prevalent among young children, with studies indicating that approximately 6-8% of the paediatric population is affected. This poses significant challenges for families and healthcare providers alike. ÎçÒ¹¾ç³¡’s innovative Peanut, Milk, and Egg Challenge meals are tailored to meet the needs of children as young as six months, but can also be used for individuals of all ages, including adults. These products have undergone comprehensive development and rigorous testing to ensure their safety and efficacy.

ÎçÒ¹¾ç³¡’s paediatric challenge meals will be the only pharma-grade products developed globally, setting a new standard in the industry. This distinction is crucial as it ensures the highest levels of safety, quality, and efficacy for children undergoing food allergy diagnosis and during clinical trials for the development of new treatments. By adhering to stringent pharmaceutical standards, ÎçÒ¹¾ç³¡ guarantees that these products meet rigorous regulatory requirements, providing healthcare providers and families with the confidence that they are using the best possible tools for managing food allergies. This global first underscores ÎçÒ¹¾ç³¡’s commitment to innovation and excellence in addressing the critical needs of the paediatric population.

Additionally the importance of considering multiple food allergies in both diagnosis and treatment has become increasingly evident. Many children with food allergies often react to more than one allergen, making it crucial for healthcare providers to adopt a comprehensive approach. The development of challenge meals to multiple allergens at ÎçÒ¹¾ç³¡ highlights the significance of addressing an important need in clinical trials. These meals are designed to meet the needs of food allergy research and clinical communities, ensuring safety, quality, and efficacy across various allergens in trial participants from the important paediatric ages through to adult and will be ready by the end of 2026.www.hyjliao.com

For more information, please contact our commercial team.

Development of standardised challenge meals to meet Regulators demands for Oral Food Challenges

T. Mendes Borges; ML. Martinez Casas; M. Wickham; H. Lett

Our challenges meals (CMs) are used in oral food challenges to support clinical trials, they consist of 3 strengths, a low and a high strength allergen product and importantly a 0% non-allergen CM. The 0% can be used in the placebo arm of a blinded placebo controlled randomised clinical trial.

To ensure safety, quality, and efficacy we have developed these using the Quality By Design (QbD)www.hyjliao.com approach.

Standardising the CMs means that we can meet more stringent regulators demands, where there has been a lot of focus on recently.

What is the QbD approach and why is it so important?www.hyjliao.com

This approach means you predetermine all the requirements for the challenge meal before starting the formulation work. This allows you to develop the product with the required quality target product profile and critical quality attributes, therefore the developed product is fit for its intended use.

For example, the 3 strengths must be comparable in terms of flavour, appearance, and texture, whilst ensuring the allergen remains masked. This is important, neither the the clinician nor the participants are not aware if they are using the non-allergen or allergen containing challenge meal. The masking also reduces the chance of a psychosomatic response in participants if they think that they can taste, see or smell the allergen.

In the next stage of the process, analytical test methods were developed and validated to make sure the product meets the established specifications adhering to current guidelines.

In addition stability studies are conducted to determine the shelf life of the CM.

To conclude, by using the QbD approach, standardised CMs have been developed meeting more stringent health authority’s requirements.

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Analytical development, validation and standardisation strategy for test methods of challenge meals which are utilised as Oral Food Challenges (OFCs) for the diagnosis and monitoring of food allergies

S. Maudsley; H. Lett; S. Rosborough; H. Payne

The double-blinded placebo controlled food challenge is currently the gold standard for food allergy diagnosis. Within the industry, there is an unmet need to standardise oral food challenges (OFCs) and regulatory authorities are requiring standardisation due to the usage of OFCs in clinical trials, where product safety, quality and efficacy is paramount.

ÎçÒ¹¾ç³¡â€™s strategy for standardisation of OFCs includes a quality by design approach and analytical testing of critical quality attributes. The quality by design approach is taken during product formulation, where product palatability, masking of allergen and dosing scheme is verified.

The analytical testing of critical quality attributes involves developing and validating test methods according to pharmaceutical guidelines.

Examples of the test methods include (but are not limited to) the following:

• SDS-PAGE – A method used to identify which allergenic proteins are present in the active substances and the challenge meals. Confirms batch to batch consistency and an indicator of protein stability.
• ELISA – The method specifically quantifies the amount of allergenic protein present in the challenge meals, confirming product strength.
• In vitro IgE assay – IgE has an important role in the immune response within allergic individuals. The assay utilises sera from allergic individuals to verify whether the active substance and the challenge meals elicit an immunological response.
• Microbial testing – To determine whether the challenge meals are free from contamination and are safe for consumption.

In summary, the standardised approach utilised for design and testing of challenge meals ensures product safety, quality and efficacy.

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What Are Oral Food Challenges?

An Oral Food Challenge (OFC) is a diagnostic test use to confirm or rule out food allergies. The process involves the ingestion of a suspected food allergen in incremental quantities under close clinical supervision. [1]

Why are OFCs Used?

OFCs are performed when a patient’s history and various tests, such as a skin prick test (SPT) or specific IgE tests provided inconclusive results. OFC are a well-established diagnostic tool in determining whether a food allergy persists or has resolved. [2]

Guidelines

The European Academy of Allergy and Clinical Immunology (EAACI) and the British Society for Allergy & Clinical Immunology (BSACI) are some examples for guidelines that help standardise the safe administration of OFCs – these detail preparation steps, dosing protocols and emergency management [3, 4]

Methods Explained

The most common methods for administering OFC are the following:

• www.hyjliao.com www.hyjliao.com www.hyjliao.com Single-Blind Placebo-Controlled Food Challenge (SBPCFC). The patient are not aware whether they are receiving the allergen or a placebo, only the clinician has knowledge of this. This method is used when subjective symptoms may influence the outcome – useful for anxious children or adults who are concerned about being exposed to a certain allergenic food [5]
• www.hyjliao.com www.hyjliao.com www.hyjliao.com Double-Blind Placebo-Controlled Food Challenge (DBPCFC). In this method both the patient and the clinician are unaware whether the administered food contains allergen or it is a placebo. This approach helps rule out reporting and measurement bias from the observer and psychological effects from the patient. For research purposes, double-blinded food challenges are still considered the gold standard in diagnosing and confirming food allergies [6]
• www.hyjliao.com www.hyjliao.com www.hyjliao.com Open food challenges are the process of choice when the patients are experiencing objective symptoms, such as angioedema – sudden swelling of body parts (e.g. face, hands) as a result of viral infection. [7]

Subjective Symptoms

These are difficult to interpret given that they are based on personal opinions and feelings rather than facts. Some of the symptoms may arise from the psychological impact of potential exposure to known allergens, resulting in stress and anxiety. [8]

• www.hyjliao.com www.hyjliao.com www.hyjliao.com Examples: nausea, irritability, sleeplessness, excitement, apprehension, change of mood/behaviour

Objective Symptoms

These symptoms are more reliable as a marker of body’s reaction to an allergen – they can be observed directly as they physically manifest and are usually obvious. [8]

• www.hyjliao.com www.hyjliao.com www.hyjliao.com Examples: flushing, worsening of eczema, vomiting, blood pressure changes, respiratory difficulties

Confirming a positive food challenge

To confirm a positive diagnosis to an allergen, the OFC process must present with at least 1 of the major criteria or 2 or more of the minor criteria listed below. Some examples of these:

• www.hyjliao.com www.hyjliao.com www.hyjliao.com Major criteria: hives appearing on more than 3 sites, emergence of angio-oedema, wheezing, dyspnoea and aphonia
• www.hyjliao.com www.hyjliao.com www.hyjliao.com Minor criteria: some sneezing and congestion, nausea and/or vomiting for under 20 minutes, anxiety, distress, drowsiness [8, 9]

Pros and Cons of OFCs

Positives:

• Highly accurate diagnosis, low risk of bias with double-blind procedures – essential for guiding dietary management​. [2]

• Helps reduce unnecessary food avoidance, improving nutritional status and quality of life​.[3]

• Can provide peace of mind and clarify tolerance levels​. Reduced anxiety around accidental exposure occurring. [3]

Negatives:

• Substantial risk of severe reactions to known allergens including anaphylaxis​. [2]

• Emotional distress for patients, especially children​.[3]

• Time-consuming and resource-intensive​. Highly trained clinical staff are required to observe patients during trial. [6]

• Conditions during OFC may not reflect real-life scenarios where accidental exposure may happen. [4]

Referenceswww.hyjliao.com

1. www.hyjliao.com www.hyjliao.com www.hyjliao.com Panel, N.-S.E., Guidelines for the diagnosis and management of food allergy in the United States: report of the NIAID-sponsored expert panel. Journal of Allergy and Clinical Immunology, 2010. 126(6): p. S1-S58.
2. www.hyjliao.com www.hyjliao.com www.hyjliao.com Nowak-Węgrzyn, A., et al., Work Group report: oral food challenge testing. Journal of Allergy and Clinical Immunology, 2009. 123(6): p. S365-S383.
3. www.hyjliao.com www.hyjliao.com www.hyjliao.com Stiefel, G., et al., BSACI guideline for the diagnosis and management of peanut and tree nut allergy. Clinical & Experimental Allergy, 2017. 47(6): p. 719-739.
4. www.hyjliao.com www.hyjliao.com www.hyjliao.com Muraro, A., et al., EAACI food allergy and anaphylaxis guidelines: diagnosis and management of food allergy. Allergy, 2014. 69(8): p. 1008-25.
5. www.hyjliao.com www.hyjliao.com www.hyjliao.com Skypala, I. and C. Venter, Food Hypersensitivity: Diagnosing and Managing Food Allergies and Intolerance. 1 ed. 2009, Newark: John Wiley & Sons, Incorporated.
6. www.hyjliao.com www.hyjliao.com www.hyjliao.com Sampson, H.A., et al., Standardizing double-blind, placebo-controlled oral food challenges: American Academy of Allergy, Asthma & Immunology–European Academy of Allergy and Clinical Immunology PRACTALL consensus report. Journal of Allergy and Clinical Immunology, 2012. 130(6): p. 1260-1274.
7. www.hyjliao.com www.hyjliao.com www.hyjliao.com Venter, C., et al., Comparison of open and double�blind placebo�controlled food challenges in diagnosis of food hypersensitivity amongst children. Journal of human nutrition and dietetics, 2007. 20(6): p. 565-579.
8. www.hyjliao.com www.hyjliao.com www.hyjliao.com Niggemann, B., When is an oral food challenge positive? Allergy, 2010. 65(1): p. 2-6.
9. www.hyjliao.com www.hyjliao.com www.hyjliao.com Joan Gandy, J.G., Manual of Dietetic Practice. Sixth edition. ed. 2019, Newark: Wiley.