Outcomes aligned with affected person wants and scientific observe priorities.
Alladapt getting ready for ADP101 Part 3 examine in 2024.
MENLO PARK, Calif., Nov. 09, 2023 (GLOBE NEWSWIRE) — Alladapt Immunotherapeutics, Inc., a non-public, clinical-stage biopharmaceutical firm creating prescription therapeutics to deal with IgE-mediated meals allergy, at the moment introduced that information from the Part 1/2 Concord examine will likely be introduced on the 2023 Annual Scientific Assembly of the American Faculty of Bronchial asthma, Allergy and Immunology (ACAAI) going down Nov. 9-13. The info show that ADP101, an investigational multi-allergen oral immunotherapy (OIT), generated dose-dependent, clinically significant responses, and a positive security and tolerability profile in pediatric sufferers allergic to a number of of the meals sources within the product. That is the primary time these information have been introduced in the USA.
Ashley Dombkowski, Ph.D., Chief Govt Officer and Co-Founding father of Alladapt, stated, “We’re excited to current the encouraging Part 1/2 security and efficacy information from our Concord examine at ACAAI. The Concord information underscore the worth of our multi-allergen method and the potential for ADP101 to deal with a profound unmet want for sufferers and their households. Additional, these information align with a number of insights from our intensive market analysis: We all know {that a} important majority of sufferers searching for meals allergy care are multi-allergic and are searching for broad therapeutic options. Healthcare professionals are motivated to offer these sufferers with substantial ranges of desensitization throughout the commonest causes of meals allergy to maximise safety towards unintentional exposures. They perceive the significance of reliability and consistency of allergenic supplies utilized in a therapeutic setting, they usually prioritize fostering a optimistic affected person expertise throughout each in-office and at-home parts of a remedy. We’re incorporating these information and insights into an enhanced Part 3 program and sit up for advancing ADP101 additional in direction of a future BLA and potential FDA approval.”
Alladapt’s ADP101 is the primary standardized, pharmaceutical-grade, multi-allergen OIT, designed to concurrently deal with allergy to a number of of the world’s most important meals allergens – particularly almond, cashew, hen’s egg, codfish, cow’s milk, hazelnut, peanut, pecan, pistachio, salmon, sesame, shrimp, soy, walnut and wheat.
Warner Carr, M.D., Allergist at Allergy & Bronchial asthma Associates of Southern California, a main investigator within the Concord examine, and the presenting writer of those information at ACAAI, added, “The Concord information is notable for a number of causes. First, the variety of illness presentation was outstanding, with 31 distinctive meals allergen mixtures confirmed among the many 61 pediatric sufferers within the examine. Subsequent, the security and tolerability information have been sturdy as evidenced by a examine discontinuation charge resulting from opposed occasions of simply 5% – a charge that was indistinguishable from the speed seen in placebo sufferers and effectively under charges generally reported within the literature for different OIT protocols. Lastly, the efficacy evaluation was promising; after lower than a yr on remedy, 56% of multi-allergic sufferers have been simultaneous responders throughout two or extra meals allergic reactions in comparison with none on placebo. Based mostly on these outcomes, ADP101 has the potential to remodel the worth proposition of oral immunotherapy for the remedy of meals allergy and develop the affected person inhabitants that could possibly be handled.”
The Part 1/2 Concord examine of ADP101 (NCT04856865) demonstrated clinically significant, dose-dependent responses in 61 pediatric sufferers with mono- and multi-food allergic reactions:
- The first endpoint was the proportion of members tolerating a single dose of at the very least 600 mg (1044 mg cumulative) of protein from a number of qualifying meals with out dose-limiting signs in a double-blind, placebo-controlled meals problem at examine exit. After solely 40 weeks on remedy, information from the intent-to-treat inhabitants revealed 55% of sufferers receiving high-dose ADP101 skilled desensitization to a single dose of 600mg (1044 mg cumulative) or extra of protein from qualifying allergens, in comparison with 20% within the placebo group.
- Secondary endpoints revealed further efficacy traits, with 56% of multi-allergic sufferers within the high-dose ADP101 arm reaching simultaneous desensitization to 600mg (1044 mg cumulative) or extra of protein from two or extra meals allergens versus a 0% response charge amongst sufferers receiving placebo. Moreover, 44% of sufferers receiving high-dose ADP101 have been desensitized to 1000mg (2044 mg cumulative) or extra of protein from two or extra meals allergens in comparison with a 0% response charge amongst sufferers on placebo. The vast majority of these responses have been generated throughout unrelated, non-cross-reactive allergens.
Security information indicated that ADP101 was well-tolerated; opposed occasions have been principally delicate or reasonable and charges diminished as sufferers moved from up-dosing into upkeep dosing. Extreme anaphylactic occasions have been rare and never associated to ADP101. No examine members on ADP101 discontinued the examine resulting from anaphylaxis. The administration of epinephrine for sufferers on energetic remedy occurred primarily throughout up-dosing and was related to the administration of delicate or reasonable reactions. The examine discontinuation charge resulting from opposed occasions was 5% whether or not sufferers have been on energetic remedy or placebo.
The poster is titled “Efficacy and Security of ADP101 Multifood Oral Immunotherapy in Meals-Allergic Sufferers within the Concord Trial” (ID P180) and its related summary might be discovered on-line in a complement to the November 2023 subject of Annals of Allergy, Bronchial asthma & Immunology, ACAAI’s scientific journal, right here. The poster presentation will happen within the ePoster Part of the Exhibit Corridor on Nov. 10 at 3 p.m. PT.
Alladapt can be conducting the Encore Examine, an open-label extension examine of the Concord examine assessing long run use of ADP101. Along with security and tolerability information, Encore is assessing potential for improved response charges general, a breadth of responses seen throughout allergens, and will increase within the magnitude of desensitization skilled by sufferers over time. Knowledge from Encore are anticipated to be reported on an annual foundation with the primary outcomes anticipated in early 2024.
In regards to the Concord Examine
The Part 1/2 Concord examine is a randomized, double-blind, placebo-controlled trial designed to judge the efficacy and security of ADP101 for inducing desensitization in sufferers with single or a number of meals allergic reactions. Eligible sufferers had a qualifying meals allergy to 1-5 meals contained in ADP101, outlined as dose-limiting signs on publicity to ≤100mg of protein on double-blind, placebo-controlled meals problem (DBPCFC) at screening. Per protocol, the trial enrolled 61 topics aged 4-17 in a pediatric cohort, and 12 topics aged 18-55 in an exploratory grownup cohort. Topics have been randomized 2:2:1:1 to high-dose ADP101, low-dose ADP101, high-dose placebo and low-dose placebo. Beforehand introduced topline examine information might be discovered right here.
About Alladapt Immunotherapeutics
Alladapt Immunotherapeutics, Inc., is a non-public, clinical-stage biopharmaceutical firm creating prescription therapeutics focusing on meals allergy. Within the U.S. alone, there are over 32 million individuals with meals allergy, a prevalence just like that of bronchial asthma or diabetes. Regardless of the severity and widespread presence of meals allergy, the present customary of take care of this critical immunologic illness is meticulous avoidance of the meals allergen and emergent use of epinephrine in case of reactions brought on by unintentional publicity.
ADP101, the Firm’s lead product candidate, is an investigational oral immunotherapy representing the 9 meals teams answerable for the overwhelming majority of great meals allergic reactions globally. The Firm has generated optimistic information within the Part 1/2 Concord examine, a randomized, double-blind, placebo-controlled examine evaluating the efficacy and security of ADP101 for the simultaneous remedy of a number of extreme meals allergic reactions in youngsters and adults. The Encore open label extension examine assessing long run use of ADP101 is ongoing, as effectively.
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 at present serves because the Chair of the Division of Environmental Well being at Harvard College of Public Well being and John Rock Professor of Local weather and Inhabitants Research. Meals allergen particular OIT performed by Dr. Nadeau and different meals allergy consultants is an method that has proven constant promising outcomes via administration of accelerating quantities of an allergen to people with meals allergy to lift their reactive threshold and reduce the severity of allergic responses to the allergenic meals. Allergen immunotherapy for environmental allergy and bug venom allergy is a longtime interventional precedent that’s thought of each efficient and illness modifying. Oral Immunotherapy for the remedy of meals allergy could supply related mechanistic promise for delivering not solely desensitization however long-term illness modifying advantages.
For extra info, please go to the Firm’s web site at www.alladapt.com.
Investor Contact:
John Woolford
ICR Westwicke
John.Woolford@westwicke.com
Media Contact:
Jon Yu
ICR Westwicke
AlladaptPR@westwicke.com
Alladapt Immunotherapeutics Presents Part 1/2 Concord Knowledge Demonstrating Therapeutic Potential and Security of ADP101 for the Therapy of Meals Allergy at 2023 ACAAI Annual Assembly|Firm Press Launch|
