Allakos Shares Tumble on Phase 3 Data of Eosinophilic Gastrointestinal Diseases Therapy

Share of Allakos fell nearly 90 percent as the company saw $3.8 billion in market cap erased as investors reacted to news that the company’s experimental treatment lirentelimab in development for the treatment of eosinophil and mast cell-related diseases failed to meet the symptomatic co-primary endpoints in both a phase 3 and a phase 2/3 study.

The company said in ENIGMA 2, a 24-week Phase 3 randomized, double-blind, placebo-controlled study of lirentelimab in patients with biopsy confirmed eosinophilic gastritis (EG) and/or eosinophilic duodenitis (EoD) and in KRYPTOS, a 24-week phase 2/3 randomized, double-blind, placebo-controlled study of lirentelimab in patients with biopsy-confirmed eosinophilic esophagitis, the studies did meet their histologic co-primary endpoints.

“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,” said Craig Paterson chief medical officer of Allakos. “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 Allakos plans to initiate the chronic spontaneous urticaria and asthma studies in 2022 and said it will continue to advance the other programs in its preclinical pipeline.

The safety results of both trials were generally consistent with previously reported lirentelimab studies. No new safety signals were observed.

Photo: Craig Paterson chief medical officer of Allakos.

Author: Rare Daily Staff