FMXIN002 in Patients at Risk of Anaphylaxis

Nasus Pharma

Status and phase: Invitation-only; Phase 3; Phase 2

Conditions: Anaphylaxis Food

Treatments: Combination Product: Epinephrine 4mg nasal powder spray; Combination Product: Adrenalin 0.5mg Injectable Product

Study type: Interventional

Funder types: Industry

Identifiers

NCT07045701

NP-009-Epinephrine

Details and patient eligibility

About

Study Objective To evaluate the efficacy of FMXIN002, a powder-based intranasal epinephrine spray, for treating anaphylaxis.

Study Design

• Hypothesis: FMXIN002 will terminate anaphylactic reactions as effectively-or more rapidly-than IM epinephrine, as measured by clinical parameters.

Full description

Study Procedures

1. Informed Consent: Participants will sign consent forms.

2. Food Challenge: Subjects will undergo routine diagnostic oral food challenges (OFC) relevant to their suspected allergens.

3. Assessment: At the first signs of allergic symptoms, a physician will assess the subject.

4. 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.

5. Randomization: 1:1 between the 2 study arms.

6. Exclusion from Trial Treatment: Severe reactions or physician discretion may warrant standard care (IM epinephrine 0.5 mg) without study drug.

7. Blinding: Double-blinded setup with pre-prepared, numbered envelopes containing randomized treatment kits (nasal spray + injection).

8. 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.

9. 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).

10. 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

11. Discharge: Participants with symptom resolution by 90 minutes will be discharged.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups

FMXIN002 4mg + saline IM

Experimental group

Description:

Epinephrine powder nasal spray together with a placebo IM injection

Treatment:

Combination Product: Epinephrine 4mg nasal powder spray

Adrenaline 0.5mg IM + placebo nasal spray

Active Comparator group

Description:

Epinephrine IM injection together with a placebo nasal spray

Treatment:

Combination Product: Adrenalin 0.5mg Injectable Product