ADP101 / Alladapt Immunotherap - LARVOL DELTA

ADP101 multifood oral immunotherapy for food-allergic patients: Harmony phase 1/2 randomized clinical trial. (PubMed, J Allergy Clin Immunol Glob) - P1/2 | "Adverse events were mostly mild or moderate, with no life-threatening events or deaths. The study did not meet its primary endpoint, but ADP101 demonstrated a favorable safety profile and increased the reactive threshold in DBPCFC in pediatric participants with single or multiple food allergies across multiple endpoints, warranting further clinical investigation."

Clinical • Journal • P1/2 data • Allergy • Food Hypersensitivity • Immunology • Pediatrics

The Encore Study: Open-label Extension Study of ADP101 (clinicaltrials.gov) - P1/2 | N=45 | Terminated | Sponsor: Alladapt Immunotherapeutics, Inc.

Trial completion date • Trial primary completion date • Trial termination • Allergy • Food Hypersensitivity • Immunology

Treatment of Single and Multiple Food Allergies with ADP101: Results of the Harmony Phase 1/2 Trial (AAAAI 2024) - P1/2 | "Severe anaphylactic events were infrequent; none were attributed to ADP101. Conclusions ADP101 demonstrated efficacy and a positive safety profile for desensitization of single and multiple food allergies in children."

P1/2 data • Allergy • Food Hypersensitivity • Immunology

A Patient-centric Approach in the Harmony Phase 1/2 Trial of ADP101 for Food Allergies: Incorporating the Patient Voice (AAAAI 2024) - P1/2 | "Patient engagement efforts will be explored further in the phase 3 program by adding more diverse voices to the PAC and by developing evaluation metrics to measure the impact of these efforts on trial recruitment and retention."

Clinical • P1/2 data • Allergy • Food Hypersensitivity • Immunology • Infectious Disease • Novel Coronavirus Disease

Efficacy and Safety of ADP101 Multifood Oral Immunotherapy in Food-Allergic Patients in the Harmony Trial (ACAAI 2023) - P1/2 | "Epinephrine was primarily used during up-dosing and for mild or moderate events. Conclusion A phase 3 program has been initiated based on ADP101’s efficacy, safety, and tolerability results."

Clinical • Allergy • Food Hypersensitivity • Pediatrics

ADP101 Simultaneous Multi- food Oral Immunotherapy (mOIT) Demonstrates Clinically Meaningful Safety and Efficacy with Dose- Dependent Response in Pediatric Patients in the Phase 1/2 Harmony Trial (EAACI 2023) - P1/2 | "There were no Grade 4 or 5 adverse events. ConclusionBased on these successful desensitization and safety results, further study of ADP101 in a Phase 3 trial is warranted."

Clinical • Late-breaking abstract • P1/2 data • Allergy • Food Hypersensitivity • Immunology

The Harmony Trial: Baseline Characteristics From a Phase 1/2 Trial of ADP101 for Oral Immunotherapy in Children and Adults With Single or Multiple Food Allergies (EAACI 2023) - P1/2 | "About one-third of patients had nonqualifying food allergy. Conclusion The Harmony trial will evaluate the potential of ADP101 as a multiallergen OIT to simultaneously treat patients with one or more food allergies."

Clinical • P1/2 data • Allergy • Food Hypersensitivity • Immunology

The Encore Study: Open-label Extension Study of ADP101 (clinicaltrials.gov) - P1/2 | N=45 | Active, not recruiting | Sponsor: Alladapt Immunotherapeutics, Inc. | N=73 ➔ 45

Enrollment change • Allergy • Food Hypersensitivity • Immunology

The Encore Study: Open-label Extension Study of ADP101 (clinicaltrials.gov) - P1/2 | N=73 | Active, not recruiting | Sponsor: Alladapt Immunotherapeutics, Inc. | Enrolling by invitation ➔ Active, not recruiting

Enrollment closed • Allergy • Food Hypersensitivity • Immunology

ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults (clinicaltrials.gov) - P1/2 | N=73 | Completed | Sponsor: Alladapt Immunotherapeutics, Inc. | Active, not recruiting ➔ Completed

Trial completion • Allergy • Food Hypersensitivity • Immunology

Open-label Extension Study of ADP101 (clinicaltrials.gov) - P1/2 | N=73 | Enrolling by invitation | Sponsor: Alladapt Immunotherapeutics, Inc.

New P1/2 trial • Allergy • Food Hypersensitivity • Immunology

ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults (clinicaltrials.gov) - P1/2; N=73; Active, not recruiting; Sponsor: Alladapt Immunotherapeutics, Inc.; Recruiting ➔ Active, not recruiting

Enrollment closed • Allergy • Food Hypersensitivity • Immunology

Alladapt Announces Completion of Patient Enrollment in its Phase 1/2 Harmony Study of ADP101 for Treatment of Food Allergy (GlobeNewswire) - "Alladapt Immunotherapeutics...today announced the completion of patient enrollment in Harmony, its Phase 1/2 study of ADP101 for the treatment of food allergy (FA)....We look forward to reporting top-line data approximately one year from now....Harmony is a randomized, double-blind, placebo-controlled Phase 1/2 study designed to evaluate the efficacy and safety of ADP101 in pediatric and adult patients with a diagnosis of allergy to one or more of the foods represented in ADP101. A total of 15 U.S. sites enrolled 73 patients in the trial."

Enrollment closed • Allergy • Food Hypersensitivity

ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults (clinicaltrials.gov) - P1/2; N=72; Recruiting; Sponsor: Alladapt Immunotherapeutics, Inc.

Clinical • New P1/2 trial • Allergy • Food Hypersensitivity • Immunology

Alladapt Commences Phase 1/2 Clinical Trial in Food Allergy (GlobeNewswire) - "Alladapt Immunotherapeutics...today announced that the first patients have been dosed in The Harmony Study, a first-in-human Phase 1/2 clinical trial to evaluate ADP101 for the treatment of food allergy....The Harmony Study is a Phase 1/2, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of ADP101 for oral immunotherapy (OIT) in children and adults diagnosed with allergy to either one food or to multiple foods from a set of the most commonly allergenic foods. The Harmony Study plans to enroll patients across 20 sites in the United States."

Trial status • Food Hypersensitivity