Alladapt Announces Completion of Patient Enrollment in its Phase 1/2 Harmony Study of ADP101 for Treatment of Food Allergy
MENLO PARK, Calif., Jan. 04, 2022 (GLOBE NEWSWIRE) -- Alladapt Immunotherapeutics Inc., a private, clinical-stage biopharmaceutical company focused on the development of prescription therapeutics to address IgE-mediated food allergy, today announced the completion of patient enrollment in Harmony, its Phase 1/2 study of ADP101 for the treatment of food allergy (FA). ADP101, the Company’s lead program, 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 allergic reactions.
“We are thrilled to report the completion of patient enrollment in our ongoing Phase 1/2 study of ADP101 and are encouraged by the outpouring of interest from the patient and physician community in the trial. Harmony swiftly and successfully enrolled a diverse group of adult and pediatric patients with a broad range of mono- and multi-food allergies, reflecting real-world patient profiles and demographics,” said Ashley Dombkowski, Ph.D., Alladapt’s Chief Executive Officer and co-founder. “With ADP101, our research goal is to advance development of a drug candidate with the potential to become the first FDA-approved oral product able to simultaneously treat patients highly reactive to foods in the nine major food groups associated with food allergic reactions, including, and extending beyond, peanut allergy. Alladapt’s ADP101 formulation and the Harmony dosing protocol are based on intellectual property and scientific research including an extensive foundational therapeutic data package licensed to Alladapt from the laboratory of our co-founder, Kari Nadeau, M.D., Ph.D. As an allergist, clinician and protein biochemist, Dr. Nadeau pioneered multi-allergen oral immunotherapy both for use as stand-alone therapy and for use with adjunctive injectable immunomodulators. 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. 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 peanut, almond, hazelnut, cashew, pistachio, pecan, walnut, milk, egg, cod, salmon, shrimp, wheat, soy and sesame. 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. The study is overseen by an independent data monitoring committee (iDMC) of food allergy experts who have conducted multiple planned reviews of unblinded patient-level data since the first patient was enrolled in April 2021. In every instance, the iDMC has recommended continuing the trial without study modification.
Commented Dana McClintock, M.D., Chief Medical Officer: “Constant, meticulous avoidance of food allergens is challenging and highly burdensome, particularly in patients with multiple food allergies. Accidental exposures occur, often in unexpected, difficult-to-manage settings like airplanes or schools. Our focus is to alleviate the burden of food allergy by advancing a comprehensive OIT with a flexible, low-and-slow up-dosing protocol designed to raise the threshold of reactivity by retraining the maladaptive food allergic immune response. We are thankful for the food allergy patients, their families, the investigators and the study site personnel who have made this study possible.”
Additional information about the Phase 1/2 Harmony trial is available at clinicaltrials.gov (NCT04856865).
ADP101 is a proprietary, standardized, oral immunotherapy drug candidate that is being studied for the treatment of food allergy to one or more foods. 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 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. 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.