Allakos Reports Positive Phase 1 AK006 Trial Results in Healthy Volunteers

SAN CARLOS, Calif., June 25, 2024 – Allakos, Inc., a biotechnology company listed on Nasdaq under the symbol ALLK, has announced encouraging outcomes from its early-stage clinical trial involving AK006. This experimental treatment is designed to address diseases driven by mast cell activation, such as chronic spontaneous urticaria, food allergies, and asthma. The trial involved the administration of intravenous (IV) doses of AK006 to healthy volunteers.

Key Findings from Phase 1 Study
Allakos tested the tolerability and safety of AK006 through single and multiple ascending doses, with the highest dose reaching 720 mg. The results were promising as the treatment was generally well-tolerated across all dosage levels. No serious adverse events or dose-limiting toxicities were reported, and no subjects had to discontinue treatment due to emergent adverse events. The most common side effects noted were mild to moderate headaches and dysmenorrhea.

Pharmacokinetics and Receptor Occupancy
The study found that AK006 displayed dose-linear exposure and has an estimated half-life of about 21 days at the 720 mg IV dose. The serum concentrations achieved were consistent with those levels previously shown to inhibit mast cells in preclinical trials. Skin biopsies from subjects receiving AK006 confirmed high receptor occupancy, indicating that the drug effectively reaches mast cells in skin tissues. In particular, doses of 20 mg or higher achieved more than 90% Siglec-6 receptor occupancy on mast cells by day 29.

Ongoing Research and Future Directions
AK006 is being further evaluated in an ongoing Phase 1 trial that includes both single and multiple ascending doses administered intravenously and subcutaneously. This trial also includes a randomized, double-blind, placebo-controlled arm to assess its efficacy in treating chronic spontaneous urticaria (CSU). Approximately 60 adult patients with antihistamine-refractory CSU will be randomized to receive either 720 mg of AK006 or a placebo every four weeks. The primary measure of efficacy will be the change in the urticaria activity score (UAS7) at week 14. Initial data from this cohort are anticipated by the end of 2024.

About AK006
AK006 is a humanized IgG1 monoclonal antibody targeting the inhibitory receptor Siglec-6, which is predominantly found on mature mast cells. The drug has shown the ability to inhibit both IgE-dependent and IgE-independent activation of mast cells in preclinical studies. It also demonstrated the capacity to reduce mast cell numbers by promoting cellular phagocytosis in the presence of activated macrophages.

About Allakos
Allakos is a clinical-stage biotechnology firm focusing on developing therapies that target immunomodulatory receptors on immune cells implicated in allergic, inflammatory, and proliferative diseases. By activating these receptors, Allakos aims to directly address the pathological cells involved in these conditions, potentially offering broad inhibition of inflammatory cells. The company's leading clinical candidate is AK006, which targets mast cells through Siglec-6. Mast cells play a critical role in various severe diseases, including those affecting the gastrointestinal tract, eyes, skin, and lungs. Preliminary studies suggest that AK006 can provide profound mast cell inhibition and reduce their numbers, making it a promising therapeutic option for several conditions.

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