Allakos Inc. (NASDAQ: ALLK) has released results from ENIGMA 2 study, which is a third phase, 24-week, double-blind, controlled lirentelimab study in patients with biopsy-confirmed eosinophilic gastritis and eosinophilic duodenitis and KRYPTOSstudy, which is a 24-week phase 2/3 double-blind, randomized, placebo-controlled lirentelimab stud in patients with confirmed eosinophilic esophagitis.
Both studies met histological co-primary endpoints
The ENIGMA 2 and KRYPTOS studies met their histologic co-primary endpoints but not the patient-reported symptomatic co-primary endpoints, which were not statistically significant.
CEO of Allakos Robert Alexander said, “We are deeply disappointed that the studies did not achieve their symptomatic endpoints. The company is grateful to the patients with eosinophilic gastrointestinal diseases (EGIDs) and to the investigators who participated in the ENIGMA and KRYPTOS trials.”
The company’s Chief Medical Officer, Dr. Craig Paterson, commented, “Although the EGID results are surprising and disappointing, we will continue to analyze the data to understand the results and to determine the path forward for lirentelimab in EGIDs. At present, we intend to continue our development efforts with subcutaneous lirentelimab in atopic dermatitis, chronic spontaneous urticaria, and asthma. The atopic dermatitis study is underway, and we plan to initiate chronic spontaneous urticaria and asthma studies in 2022 and will continue to advance other programs in our preclinical pipeline.”
Study results consistent with past lirentelimab studies
The third phase co-primary endpoints were the number of patients that attained histological resolution and symptomatic improvement as recorded by absolute change in the six symptoms Total Symptom Score. The ENIGMA study safety results were consistent with those from past lirentelimab studies. There were no new safety signs observed, although there were mild to moderate reactions related to infusion, which occurred in 34% of the subjects treated with lirentelimab and 14% of the patients on placebo.
In the KRYPTOS Phase 2/3 study, the co-primary endpoints were the number of patients that attained histological resolution and asymptomatic improvement based on the absolute change in dysphagia symptom questionnaire. Also, the results were consistent with those of past studies, and no adverse events were reported.
