Efficacy, Safety and Pharmacokinetics of LP-003 in Peanut Allergic Patients

This is a multicenter, randomized, double-blind, placebo-controlled, Phase 2 multiregional clinical study designed to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of LP-003 in participants with peanut allergy. The study will enroll approximately 80 participants aged 12 to 55 years with confirmed peanut allergy, including a clinical history of peanut allergy, positive peanut-specific IgE or Ara h 2-specific IgE, positive peanut skin prick test, and dose-limiting symptoms during a baseline double-blind, placebo-controlled food challenge at a single dose of 100 mg or less of peanut protein.

Participants who meet screening criteria will be assigned to Part A or Part B based on baseline body weight and total IgE according to the FDA-approved omalizumab dosing table. Part A will include approximately 20 participants who are not eligible for treatment with omalizumab, based on the omalizumab dosing table; this will include participants with baseline total IgE greater than 2000 IU/mL. Part B will include approximately 60 participants who are eligible for treatment with omalizumab, per the omalizumab dosing table. Within each part, participants will be randomized in a 2:2:1 ratio to receive LP-003 dose level 1 LP-003 dose level 2, or placebo by subcutaneous injection once every 8 weeks. Randomization will be stratified by age group, with groups defined as younger than 18 years or equal to or greater than 18 years old.

The study includes a screening period of up to 4 weeks, a 24-week double-blind treatment period, a 24-week blinded extension treatment period, and an approximately 32-week blinded follow-up period. During the double-blind treatment period, participants will receive their assigned study intervention and will undergo efficacy, safety, pharmacokinetic, pharmacodynamic, and immunogenicity assessments according to the study schedule. The primary efficacy assessment will be performed at Week 24 using a supervised double-blind, placebo-controlled food challenge. The primary endpoint is the proportion of participants who can consume a single dose of at least 600 mg of peanut protein without dose-limiting symptoms.

Participants who complete the Week 24 visit will enter a blinded extension treatment period and receive LP-003 300 mg every 8 weeks for three doses. A final double-blind, placebo-controlled food challenge will be performed at Week 48 to determine efficacy. After the Week 48 visit, participants will enter a blinded follow-up period of approximately 32 weeks to allow drug clearance and continued safety monitoring. During the follow-up period, safety, pharmacokinetic, pharmacodynamic, and immunogenicity assessments will continue.

Secondary efficacy assessments include the maximum tolerated peanut dose without symptoms, symptom-free response rates at different peanut challenge dose levels, use of rescue medication, and the proportion of participants who can tolerate higher peanut protein challenge doses at Weeks 24 and 48. Safety will be assessed by monitoring adverse events, serious adverse events, adverse events of special interest, laboratory tests, vital signs, physical examinations, electrocardiograms, injection-site reactions, and other clinically relevant findings. Exploratory assessments include skin prick test responses, peanut allergen-specific IgE, serum total IgE and free IgE, LP-003 plasma concentrations and Food Allergy Quality of Life Questionnaire results.

Briefing Inclusion Criteria:

• Age ≥ 12 years and ≤ 55 years, regardless of gender.
• Documented medical history of allergy to peanuts or peanut-containing foods.
• Peanut sIgE ≥ 0.35 kUA/L at Screening Visit 1.
• Positive SPT for peanut allergens at Screening Visit 1.
• A positive peanut DBPCFC at baseline (Screening Visit 2) defined as the occurrence of dose-limiting symptoms at a single dose ≤ 100 mg of peanut protein. Eligibility to proceed with the DBPCFC requires fulfillment of all other eligibility criteria.
• Participants agree to avoid exposure to the corresponding allergens and any other peanut foods that may cause allergies throughout the study period.
• Participants have no plans for pregnancy and agree to use effective contraception during the trial and for until 6 months after the last administration of the investigational product.
• Participants and/or their parents/legal guardians are able to understand and voluntarily sign the informed consent form.

Briefing Exclusion Criteria:

• History of hypersensitivity to LP-003 and its excipients and other biologics (i.e. Omalizumab or to other murine, chimeric or human antibodies).
• Hypersensitivity or suspected/known allergy to any of the matrix components used within the material for oral food challenge (excluding the test allergens peanut etc.).
• History of severe allergic reactions or anaphylaxis (anaphylactic shock) to participant-specific foods (i.e. peanut) in this study, defined as neurological damage or requiring intubation.
• Uncontrolled asthma at the screening according to the 2025 GINA Severe Asthma Guide.
• Current use of oral, IM, or IV corticosteroid, tricyclic antidepressants, or β-blockers (oral or topical).
• Received oral, IM, or IV corticosteroids or tricyclic antidepressants for an indication other than asthma/wheezing within 30 days prior to screening.
• Current or previous history of a mast cell disorder, including mastocytosis.
• Inability to discontinue antihistamines for the minimum wash-out periods required for SPTs or DBPCFCs.
• Participants who have used immune modulate biologics (e.g., Omalizumab, Dupixent, anti-IL-5) within 6 months prior to screening or within 5 half-lives (whichever is longer).
• Participated in other clinical trials of medications within 3 months prior to screening or within 5 half-lives of the drug (whichever is longer).
• Participants who have undergone immunotherapy for any food related to the study within the past 6 months (e.g., oral immunotherapy [OIT], sublingual immunotherapy [SLIT]).
• Currently on "build-up phase" of inhalant allergen immunotherapy (i.e., has not reach maintenance dosing). Note: individuals on stable maintenance dosing can be enrolled.
• Participants with severe peanut-related eczema, herpetiform dermatitis, eosinophilic esophagitis, eosinophilic gastrointestinal disorders, colitis, peanut FPIES, or other gastrointestinal diseases.
• Significant screening laboratory abnormalities, serious medical conditions (e.g., severe arrhythmia, uncontrolled hypertension, severe pulmonary disease), or lab abnormalities judged by the investigator to jeopardize safe study participation.
• History of malignancy was diagnosed within the past 5 years.
• Pregnant or breastfeeding women, or participants planning to become pregnant during the study period.
• Any other circumstances that the investigator considers may make the participant unsuitable for participation in the trial.