Allakos Doses First Patient in Urticaria Clinical Trial

Biotechnology company, Allakos (Nasdaq: ALLK) has dosed the first patient in a Phase 1 clinical trial evaluating a treatment for chronic spontaneous urticaria (CSU). CSU, also known as hives, is characterized by the appearance of urticaria three to four times a week, for at least six weeks. The reaction can occur with or without a known trigger.

Allakos is evaluating AK006 in a randomized, double-blind, placebo-controlled Phase 1 trial designed to assess its safety, tolerability and pharmacokinetics, and to explore its therapeutic effects using the urticaria activity score (UAS7) at 14 weeks. Top-line results from approximately 30 patients are expected to be reported at the end of 2024.

CSU symptoms are caused by the inappropriate activation of mast cells in the skin. Allakos is testing the efficacy of AK006, a humanized IgG1 monoclonal antibody which activates the inhibitory receptor Siglec-6. Siglec-6 is found on the surface of mature mast cells and offers a way to selectively target mast cells.

Allakos’s trial will also include a multiple ascending dose segment that includes a randomized, double-blind, placebo-controlled CSU arm. The CSU arm will enroll up to 60 adult patients with antihistamine refractory CSU.

About Allakos

Allakos is a clinical stage biotechnology company developing therapeutics that target immunomodulatory receptors present on immune effector cells involved in allergy, inflammatory and proliferative diseases. Activating these immunomodulatory receptors allows for the direct targeting of cells involved in disease pathogenesis and, in the setting of allergy and inflammation, has the potential to result in broad inhibition of inflammatory cells. The Company’s most advanced antibody in ongoing clinical development is AK006. AK006 targets Siglec-6, an inhibitory receptor expressed on mast cells. Mast cells are widely distributed in the body and play a central role in the inflammatory response. Inappropriately activated mast cells have been identified as key drivers in a number of severe diseases affecting the gastrointestinal tract, eyes, skin, lungs and other organs. In preclinical studies, AK006 appears to provide deep mast cell inhibition and, in addition to its inhibitory activity, reduce mast cell numbers. For more information, please visit the Company’s website at


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Allakos Doses First Patient in Urticaria Clinical Trial

Catie Corcoran

Biotech Editor