FMXIN002 in Patients at Risk of Anaphylaxis

Study Procedures

• Informed Consent: Participants will sign consent forms.
• Food Challenge: Subjects will undergo routine diagnostic oral food challenges (OFC) relevant to their suspected allergens.
• Assessment: At the first signs of allergic symptoms, a physician will assess the subject.
• Treatment Criteria: If a Grade II or III anaphylactic reaction occurs, the participant will receive either:

A). Intranasal spray of epinephrine FMXIN002 4mg + placebo saline injection B). Intranasal spray of placebo + intramuscular epinephrine injection (Adrenalin 0.5mg)

One administration will always be epinephrine; the other, placebo.

• Randomization: 1:1 between the 2 study arms.
• Exclusion from Trial Treatment: Severe reactions or physician discretion may warrant standard care (IM epinephrine 0.5 mg) without study drug.
• Blinding: Double-blinded setup with pre-prepared, numbered envelopes containing randomized treatment kits (nasal spray + injection).
• Supportive Treatment: All participants will receive antihistamines (Fenistil drops + fexofenadine 180 mg or desloratadine 5 mg). Inhaled bronchodilators (e.g., Ventolin) will be provided for respiratory symptoms as needed.
• Monitoring: Assessments at baseline, symptom onset, and at 3, 5, 10, 15, 30, and 90 minutes post-treatment. Vital signs and system-based symptom assessments will be recorded (Appendix 3).
• Rescue Therapy: If no improvement in 3-5 minutes, a second IM epinephrine dose (0.5 mg) will be given. Further treatment will follow standard anaphylaxis protocols
• Discharge: Participants with symptom resolution by 90 minutes will be discharged.

Inclusion criteria

• Age 18-40 years, any gender
• Documented or suspected food allergy (based on IgE level or clinical history)
• Development of Grade II or III reaction during OFC

Exclusion criteria

• Age <18 or >40
• Poorly controlled asthma (FEV1 < 80% or frequent symptoms)
• Active eosinophilic esophagitis
• Pregnancy or risk of pregnancy
• Mild (Grade I) or very severe (Grade IV) reactions during OFC
• Decline to participate