Alladapt Immunotherapeutics has delivered early clinical evidence that it can desensitize multiple food allergies with a single oral immunotherapy. The phase 1/2 clinical trial reported dose-dependent changes in recipients of the multi-allergen candidate, encouraging the company to plot a late-stage program.
California-based Alladapt has hoovered up money in recent years, raising $119 million in 2022 to add to the $60 million it secured in 2020 on the strength of its vision for transforming the treatment of food allergies. The use of single-allergen oral immunotherapy is limited by the need to give multiple products across sequential rounds of treatment for people who react badly to more than one type of food.
Alladapt’s solution is ADP101, a multi-food oral immunotherapy for the simultaneous treatment of food allergies to almond, cashew, hen’s egg, codfish, cow’s milk, hazelnut, peanut, pecan, pistachio, salmon, sesame seed, shrimp, soy, walnut and wheat. ADP101 contains a mixture of protein from all 15 foods.
To test whether ADP101 can simultaneously treat one or more food allergies, Alladapt randomized 61 people aged four to 17 years to take one of two doses of the drug candidate or placebo and enrolled 12 adults in an exploratory cohort. Participants had dose-limiting symptoms to 100 mg or less of one to five of the foods targeted by ADP101. Almost half of the participants were allergic to two or more food allergens.
After 40 weeks of daily dosing, 50% of people on the high dose were desensitized to 1000 mg of protein from one or more of the targeted foods. The figures for the placebo and low-dose group were 15% and 23.8%, respectively. Desensitization to at least two foods was higher, too, with 55.6% of people able to tolerate 600 mg and 44.4% desensitized to 1000 mg. The placebo arm rates were 0%.
Alladapt saw responses across non-cross-reactive food groups and said ADP101 had a favorable safety and tolerability profile. Grade 3 anaphylaxis was “infrequent,” and none of the events were attributed to the study drug. No patients experienced grade 4 or 5 adverse events. One patient in each treatment arm dropped out because of adverse events.
Buoyed by the results, Alladapt plans to start a phase 3 program next year to generate data to support approval in children. The biotech secured a $50 million loan last year to fund development of ADP101 through to the start of a phase 3 trial.