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Accelerating Food Allergy Drug Development

Allergic and food-related disorders present complex therapeutic challenges, with rising prevalence and limited treatment options underscoring the urgent need for innovative solutions. Protheragen stands as a specialized partner in preclinical drug development for allergy and food therapeutics, offering a comprehensive suite of services spanning target validation, lead optimization, pharmacology, toxicology, and IND-enabling studies. Leveraging deep scientific expertise and state-of-the-art platforms, Protheragen integrates advanced in vitro and in vivo models to accelerate the identification and characterization of novel candidates. The company’s rigorous approach ensures robust data generation and full alignment with global regulatory standards, reducing risk and enhancing the translational potential of each program. Protheragen’s multidisciplinary team collaborates closely with clients to address the unique complexities of allergy and food therapeutic development, delivering tailored solutions that drive projects efficiently from discovery to regulatory submission. Committed to advancing the field, Protheragen empowers partners to achieve therapeutic breakthroughs that address unmet patient needs in allergy and food-related diseases.

What is Food AllergyTargets for Food AllergyDrug Discovery and Development ServicesWhy Choose Us

What is Food Allergy

Food allergy is an adverse immune response to specific dietary proteins, most commonly found in foods such as milk, eggs, peanuts, tree nuts, soy, wheat, fish, and shellfish. The condition arises when the immune system mistakenly identifies these proteins as harmful, leading to inappropriate activation of immune pathways. The pathogenesis is primarily IgE-mediated, involving the production of food-specific IgE antibodies that bind to mast cells and basophils, triggering the release of histamine and other mediators upon re-exposure. Non-IgE-mediated and mixed mechanisms, involving T cells and other immune components, can also contribute, resulting in a range of immediate and delayed immune responses. Clinically, food allergy presents with symptoms ranging from mild urticaria and gastrointestinal distress to severe, potentially life-threatening anaphylaxis. Diagnosis is based on a thorough clinical history, physical examination, skin prick testing, measurement of serum food-specific IgE, and, when necessary, elimination diets followed by supervised oral food challenges. For non-IgE-mediated allergies, diagnosis relies on clinical history and symptom resolution after food elimination. Treatment focuses on strict avoidance of the offending food, emergency preparedness with medications like epinephrine, and, in select cases, oral immunotherapy (such as peanut allergen powder) or adjunctive therapies like omalizumab to reduce reaction risk and improve desensitization.

Launched Drugs

Generic Name CAS Registry Number
peanut (Arachis hypogaea) allergen powder-dnfp (USAN)
omalizumab (Rec INN; USAN) 242138-07-4

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Targets for Food Allergy

Targets in Clinical or Later Phases of Development

Target Name Gene Symbol
immunoglobulin heavy constant epsilon IGHE
IgE Receptors (nonspecified subtype)
Immunoglobulin E (IgE)
histamine receptor H1 HRH1
phosphodiesterase 6D PDE6D
CD3 Complex (T Cell Receptor Complex)
TNF receptor superfamily member 17 TNFRSF17
Bruton tyrosine kinase BTK

Food allergy involves a complex interplay of immune pathways, with several molecular targets driving disease onset and progression. Central to the allergic response are immunoglobulin heavy constant epsilon (IGHE), which encodes the IgE antibody pivotal for mast cell and basophil activation, and histamine receptor H1 (HRH1), which mediates the acute symptoms following histamine release. Key cytokines such as interleukin 13 (IL13), interleukin 17A (IL17A), and interleukin 17F (IL17F) orchestrate Th2 and Th17 immune responses, promoting IgE class switching, tissue inflammation, and barrier dysfunction. Innate immune sensors like toll like receptor 4 (TLR4) and toll like receptor 9 (TLR9) amplify allergic sensitization by activating dendritic cells and skewing T-cell responses, while adaptive regulators including Bruton tyrosine kinase (BTK), microRNA 155 (MIR155), TNF receptor superfamily member 1B (TNFRSF1B), and C-C motif chemokine receptor 9 (CCR9) modulate B and T cell activation, migration, and cytokine production. Therapeutically, these targets offer multiple intervention points to disrupt the allergic cascade. Anti-IgE monoclonal antibodies (e.g., omalizumab) and HRH1 antagonists (antihistamines) are already used to reduce symptoms and prevent severe reactions. Emerging therapies include monoclonal antibodies against IL13, IL17A, and IL17F, as well as small molecule inhibitors of BTK and antagonists of TLR4, TLR9, TNFRSF1B, and CCR9, many of which are under clinical or preclinical investigation. Targeting MIR155 offers a novel nucleic acid-based strategy to modulate immune regulation. Collectively, these approaches hold promise for disease modification, improved symptom control, and prevention of life-threatening reactions, supporting the development of precision medicine in food allergy.

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Drug Discovery and Development Services

In Vitro Efficacy Testing ServicesIn Vivo Model DevelopmentPK/PD Study ServicesIn Vivo Toxicity Assessment ServicesBiomarker Analysis Services
In Vitro Efficacy Testing Services

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Our In Vitro Efficacy Testing Service accelerates food allergy drug discovery by providing robust platforms for screening and characterizing candidate therapies. We offer a comprehensive suite of biochemical, cell-based, and molecular assays targeting key pathways, including IgE, FcεRI, mast cells, and cytokines. Advanced methods such as flow cytometry, ELISA, FRET, surface plasmon resonance, and gene reporter assays enable precise evaluation of potency, efficacy, and binding affinity. Our data-driven approach supports mechanism-of-action studies and lead optimization, delivering actionable insights to advance therapeutic development and regulatory submissions in the field of food allergy.

Bruton Tyrosine Kinase C-C Motif Chemokine Receptor 9
Histamine Receptor H1 Interleukin 13
Interleukin 17A Interleukin 17F
Tnf Receptor Superfamily Member 17 Toll Like Receptor 4

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Why Choose Us

Choosing Protheragen for your Allergy, food drug development needs means partnering with a team dedicated to advancing innovative therapeutics in this critical field. At Protheragen, we bring specialized expertise in Allergy, food research, supported by years of experience in developing novel treatments that address complex immunological and dietary challenges. Our professional teams combine deep scientific knowledge with hands-on experience, utilizing advanced technology platforms to streamline every stage of preclinical development. Protheragen has established a strong track record of reliability, consistently delivering high-quality preclinical drug development services that meet or exceed client expectations. We adhere to stringent quality standards and maintain full regulatory compliance, ensuring that every project is conducted with the utmost integrity and in accordance with international guidelines. Above all, Protheragen is committed to driving progress in Allergy, food therapeutics, working closely with our partners to bring safe and effective solutions to patients in need. When you choose Protheragen, you gain a trusted collaborator dedicated to excellence, innovation, and the successful development of new Allergy, food treatments.

FAQs for Our Services

Q: What are the main preclinical research challenges specific to developing new drugs for food allergies?

A: Preclinical research for food allergy therapeutics presents unique challenges, including the need to accurately model human immune responses to specific food allergens. Animal models must closely mimic the sensitization and elicitation phases of food allergy, which can be complex due to species differences. Identifying reliable biomarkers and endpoints for efficacy and safety assessment is also critical. Our company addresses these challenges by utilizing validated in vivo and in vitro models, coupled with advanced immunological assays tailored to food allergy mechanisms.

Q: What regulatory considerations should be taken into account during preclinical development of food allergy drugs?

A: Regulatory agencies such as the FDA and EMA require comprehensive safety and efficacy data before approving clinical trials for food allergy drugs. This includes demonstrating the absence of off-target immune activation, anaphylaxis risk, and long-term safety in relevant animal models. Allergen-specific immunotherapy products may also require additional characterization of allergen extracts or recombinant proteins. Our team ensures that all studies are designed to meet regulatory guidelines and prepares detailed preclinical data packages to support IND/CTA submissions.

Q: What technical aspects are critical for successful preclinical research in food allergy drug development?

A: Key technical aspects include the selection and validation of appropriate animal models (such as mouse or non-human primate models sensitized to relevant food allergens), development of robust immunological assays (e.g., ELISA, flow cytometry for IgE/IgG, cytokine profiling), and the use of standardized challenge protocols. Our facilities are equipped to conduct oral, intraperitoneal, and inhalation challenge tests, and we have expertise in translational biomarker discovery to bridge preclinical and clinical phases.

Q: What are the typical timeline and cost considerations for preclinical development of food allergy therapeutics?

A: Preclinical development timelines for food allergy drugs typically range from 12 to 24 months, depending on the complexity of the program and regulatory requirements. Costs can vary widely based on the extent of safety pharmacology, toxicology, and efficacy studies required, but generally range from $1 million to $5 million. Our company offers flexible, milestone-driven project management to optimize timelines and budget, ensuring efficient progression from discovery through IND-enabling studies.

Q: What are the key success factors in preclinical drug development for food allergies?

A: Success in preclinical food allergy drug development hinges on selecting predictive models, generating high-quality and reproducible data, and maintaining close alignment with evolving regulatory expectations. Early identification of safety signals, clear demonstration of mechanism of action, and robust characterization of pharmacodynamics and pharmacokinetics are essential. Our integrated approach, combining scientific expertise, regulatory experience, and state-of-the-art technology, maximizes the likelihood of advancing promising candidates to clinical trials.

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