Alladapt Announces Initiation of Encore Open-Label Extension Study for its Harmony Phase 1/2 Study of ADP101 for Treatment of Food Allergy
Harmony remains ongoing, with OLE study intended to gain insights into long-term exposure to ADP101 in qualifying patients
MENLO PARK, Calif., March 17, 2022 (GLOBE NEWSWIRE) — Alladapt Immunotherapeutics Inc., a private, clinical-stage biopharmaceutical company developing prescription therapeutics to address IgE-mediated food allergy, today announced the first patient has been dosed in Encore, the Company’s open-label extension (OLE) study for food allergy patients who completed participation in Harmony, its Phase 1/2 study of ADP101. ADP101 is a potentially best-in-class oral immunotherapy (OIT) designed to desensitize patients allergic to one or multiple foods simultaneously to mitigate risk of severe, life-threatening food-allergic reactions.
Ashley Dombkowski, Ph.D., Alladapt’s Chief Executive Officer and co-founder commented: “We are extremely encouraged by the strong interest Harmony patients are showing in our clinical development program by returning to participate in the Encore open-label extension study. The advancement of our lead asset, ADP101, into an OLE study is also a testament to the dedicated teams at Alladapt and at our clinical trial sites who worked tirelessly against the backdrop of the COVID-19 pandemic to conduct innovative food allergy research while supporting patients. Food allergy remains a major chronic unmet medical need leading to severe physical and psychological burden. We are proud to reach this inflection point as we work to continue making meaningful contributions to the field.”
“The Encore study is designed to assess the long-term safety and efficacy of ADP101 in patients who are allergic to one or more of the 15 most commonly allergenic foods,” said Dana McClintock, M.D., Alladapt’s Chief Medical Officer. “As an OLE study, Encore will enroll patients who completed the Harmony Phase 1/2 study. Furthermore, patients randomized to the active drug in Harmony will continue on active treatment in Encore, while patients who received placebo will initiate updosing with the active drug. All participants will also receive periodic food challenges to evaluate potential clinical benefits that may accompany extended maintenance therapy. The growth of our ADP101 program underscores our long-term commitment to deliver new treatment options for patients who are burdened by food allergy.”
Additional information about the open-label extension trial is available at clinicaltrials.gov (NCT05243719).
About ADP101
ADP101 is a proprietary, standardized, oral immunotherapy drug candidate that is being studied for the treatment of food allergy to one or more foods in ADP101. ADP101 is formulated to consistently deliver a well-characterized investigational drug product sourced from the most commonly allergenic food groups and designed to be administered as part of a clinically monitored dosing protocol. The goal of oral immunotherapy is to induce a state of clinically meaningful desensitization to food proteins, defined as the absence of moderate or severe allergic reaction following the ingestion of small but potentially
dangerous amounts of food.
About the Harmony and Encore Studies
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. Nearly two thirds of participants demonstrated allergy to more than one food on double-blind, placebo-controlled food challenge (DBPCFC). The final enrolled population is comprised of patients with allergy to at least one of each of the 15 targeted allergens listed below, as determined by DBPCFC. These allergens include almond, cashew, chicken’s egg, codfish, cow’s milk, hazelnut, peanut, pecan, pistachio, salmon, sesame seed, shrimp, soy, walnut, and wheat. Furthermore, patients enrolled in the study were reactive to as little as one milligram of protein from an allergenic food, including from non-peanut foods.
Encore is an open label extension study designed for subjects who successfully completed the Harmony Study. In Encore, patients previously randomized to the active drug in Harmony continue on active treatment while patients who previously received placebo in Harmony initiate updosing with the active drug. Encore patients will receive periodic food challenges over time to assess long-term safety and the potential clinical benefits that may accompany extended maintenance therapy.
About Food Allergy
FA is a common and serious condition that affects children and adults and is associated with severe reactions, including life-threatening allergic reactions. For ~95% of an estimated 32 million U.S. patients with FA, the only standard of care is strict avoidance of food allergen consumption or contact. Despite efforts to avoid consumption or contact, accidental exposures can occur and can cause rapid, multi-system and potentially life-threatening allergic reactions that necessitate the use of epinephrine as rescue treatment. With multi-allergy prevalence on the rise and an estimated 50% of U.S. FA patients having sought emergency care (Gupta, 2018 and 2019), there exists an urgent need for innovative treatment options to address this disease. There are no FDA-approved therapies to treat the majority of FA patients and oral immunotherapy is a treatment approach that – based on foundational research – presents encouraging potential as a treatment for a range of common sources of food allergy.
About Alladapt Immunotherapeutics
Alladapt Immunotherapeutics Inc. is a private, clinical-stage biopharmaceutical company developing prescription therapeutics targeting food allergy. The company is currently conducting the Harmony Study, a Phase 1/2, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of ADP101 for the treatment of food allergy in children and adults and the Encore Study, an open-label extension study for its Harmony study. ADP101 is an investigational oral immunotherapy product candidate representing the nine food groups responsible for the vast majority of significant food allergic reactions.
Alladapt was co-founded in 2018 by biotechnology entrepreneur, Ashley Dombkowski, Ph.D. and allergist, clinician and protein biochemist, Kari Nadeau, M.D., Ph.D. Dr. Nadeau is also the Naddisy Foundation Endowed Professor of Medicine and Pediatrics and Director of the Sean N. Parker Center for Allergy and Asthma Research at Stanford University. Food allergen specific OIT conducted by Dr. Nadeau and other food allergy experts is an approach that has shown consistently promising results through administration of increasing amounts of an allergen to individuals with food allergy to raise the threshold and decrease the severity of allergic responses to the allergenic food. This work, combined with research on disease mechanisms, pathways, and protein structures, led the founders to envision biopharmaceutical interventions capable of addressing food allergy due to a wide-ranging set of foods. Gurnet Point Capital, a private investment firm focused on the healthcare and life sciences sectors, was Alladapt’s founding investor.
For more information, please visit the Company’s website at www.alladapt.com.
Source: Alladapt Immunotherapeutics, Inc.
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