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
Excerpt from the Press Release:
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.”
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