Allakos Phase 2 Trials for Atopic Dermatitis and Urticaria Miss Primary Goals

Allakos, a California-based biotech firm, has announced disappointing results from two pivotal clinical trials involving its drug candidate, lirentelimab. The trials, ATLAS and MAVERICK, were designed to evaluate the efficacy and safety of the drug in treating atopic dermatitis and chronic spontaneous urticaria respectively. Unfortunately, neither study achieved its primary endpoint, leading the company to halt further development of lirentelimab.

The ATLAS trial, a phase 2 study, involved 122 adult patients with moderate-to-severe atopic dermatitis who were inadequately controlled by topical medications. The primary outcome measure was a significant reduction in the Eczema Area and Severity Index (EASI-75). However, the proportion of patients achieving this reduction was not statistically significant between the lirentelimab group and the placebo group. Similar results were observed in the MAVERICK trial, a phase 2b study with 123 adult patients suffering from moderate-to-severe chronic spontaneous urticaria. The primary endpoint focused on the absolute change in Urticaria Activity Score (UAS7), which also did not show a significant difference between the treatment and control groups.

Despite the lack of efficacy, the drug did demonstrate its intended biological effect by depleting blood eosinophil counts, a type of white blood cell associated with allergic reactions. In both trials, lirentelimab-treated patients showed a substantial reduction in eosinophil levels compared to placebo-treated patients.

Safety profiles of lirentelimab were consistent with previous trials, with the most common adverse events being injection-related reactions. The incidence of these reactions was higher in the lirentelimab group compared to the placebo group in both trials.

Allakos expressed gratitude to all involved in the trials and has decided to shift its focus to the clinical development of AK006, another antibody targeting a different aspect of the immune response. AK006 is currently in clinical trials and is being evaluated for its potential in treating various inflammatory conditions.

The company will host a conference call and webcast to discuss the trial results and future plans in more detail. Investors and the media are encouraged to participate for further insights into Allakos' strategy moving forward.

Allakos is committed to developing therapeutics that target specific immunomodulatory receptors on immune effector cells. The company's pipeline includes innovative treatments that could potentially offer new options for patients with severe allergic, inflammatory, and proliferative diseases.