Alladapt Immunotherapeutics has announced it will manufacture its pipeline candidate ADP101 for its upcoming Phase III trial, which is due to start in 2024.

The California-based food allergy company was previously using a CMO but said it has nearly finished building a 53,000ft² manufacturing facility to supply the company for its Phase III trial, market and other clinical trials.

ADP101 is an investigational oral immunotherapy representing the nine food groups responsible for the majority of food allergies, including cow’s milk, eggs, tree nuts, peanuts, shellfish, and sesame. The candidate is currently being trialled in paediatric patients, aged between four and 17 years.

Phase III trial design to be confirmed

Alladapt is in discussions with the US Food and Drug Administration (FDA) about the Phase III trial design, which will use the same age range as the Phase I/II Harmony study. The study will initiate in 2024 and is estimated to last 12 months.

CEO Dr Ashley Dombkowski told the Clinical Trials Arena that the Phase III trial will be a placebo-controlled study with 11 steps. Patients can increase in as little as two weeks between the steps.

The primary endpoints will evaluate both the efficacy and safety of the candidate. Currently, plans are limited to the US but Dombkowski hopes to further branch out to Europe and Asia during Phase III.

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Results from the Harmony study demonstrated clinically meaningful results and a dose-dependent response across multiple endpoints. Desensitisation to 600mg or more of protein from one or more allergens at 40 weeks was observed in 20% of patients receiving a placebo, 38% in low-dose ADP101 and 55% in high-dose ADP101.

The study also showed desensitisation potential to multiple food allergens simultaneously, with high-dose ADP101 showing a strong response that persisted at the 1000mg or higher threshold.

Phase III will continue in paediatric patients

Dombkowski said that ADP101 has not been investigated in enough adult patients yet but this is said to be something the company is looking to investigate soon.

“Before we would move into adult populations, we would want to do additional work to understand the needs of adults,” Dombkowski said.

“To go into patients younger than four years of age, we would also need to do additional Phase II work before we could go to those patients.”