Allakos Begins Phase 1 Trial of AK006 in Chronic Spontaneous Urticaria

SAN CARLOS, Calif., May 28, 2024 – Allakos (Nasdaq: ALLK), a biotechnology company focused on developing treatments for mast cell-driven diseases, has commenced a Phase 1 clinical trial for its investigational drug AK006, aimed at treating chronic spontaneous urticaria (CSU). The first patient has been dosed in this randomized, double-blind, placebo-controlled trial, which will evaluate the safety, tolerability, and pharmacokinetics of AK006. Additionally, the trial will explore the therapeutic impact of AK006 on CSU symptoms using the urticaria activity score (UAS7) over a 14-week period. Initial results from the trial are anticipated by the end of 2024.

Understanding Chronic Spontaneous Urticaria

CSU is characterized by the improper activation of mast cells in the skin, leading to severe itching and hives. This condition can be driven by IgE-dependent pathways, where IgE antibodies trigger mast cell activation, or through IgE-independent pathways such as the MRGPRX2 receptor. Therapies targeting both these pathways offer potential for broader efficacy across a diverse patient population and may result in improved symptom control.

About AK006

AK006 is a humanized IgG1 monoclonal antibody designed to activate the inhibitory receptor Siglec-6, which is present on mature mast cells. In preclinical studies, AK006 has shown the ability to inhibit mast cell activation through both IgE-dependent and IgE-independent mechanisms, including the MRGPRX2 and KIT receptors. The drug not only suppresses mast cell activity but also reduces mast cell numbers via antibody-dependent cellular phagocytosis when macrophages are activated.

Details of the Phase 1 Trial

The Phase 1 trial for AK006 includes both single and multiple ascending dose components and features a placebo-controlled arm specifically for CSU patients (NCT06072157). Up to 60 adult patients with antihistamine-refractory CSU, including those previously treated with biologics, will be enrolled. Participants will be randomized in a 2:1 ratio to receive either intravenous AK006 or a placebo every four weeks. The primary efficacy endpoint will be the change in the UAS7 score at week 14, with data expected from approximately 30 patients by the end of 2024.

About Allakos Inc.

Allakos is an innovative biotechnology company engaged in developing therapies targeting immunomodulatory receptors on immune cells implicated in allergy, inflammatory, and proliferative diseases. By activating these receptors, Allakos aims to directly target cells involved in disease mechanisms, potentially leading to broad inhibition of inflammatory responses. The company's lead candidate, AK006, targets Siglec-6, a receptor on mast cells that play a crucial role in various severe conditions affecting multiple organs. Preclinical research indicates that AK006 provides significant mast cell inhibition and reduces their numbers.

In summary, Allakos's Phase 1 trial for AK006 represents a significant step forward in developing treatments for chronic spontaneous urticaria, with the potential to offer relief for patients with limited options. The trial's results, expected by the end of 2024, could pave the way for more advanced clinical studies and eventually, new therapeutic options for CSU patients.

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