Allakos Announces Phase 1 Trial Results of Subcutaneous AK006 in Healthy Volunteers

Core Insights - Allakos Inc. announced positive Phase 1 results for subcutaneous AK006, a monoclonal antibody targeting mast cell-driven diseases, showing approximately 77% bioavailability and a favorable safety profile [1][2][3] Group 1: Study Results - Subcutaneous AK006 demonstrated an estimated half-life of 12-22 days and achieved 98% receptor occupancy at a 720 mg dose by day 113, indicating potential for infrequent dosing [2][3] - The study included healthy volunteers randomized to receive either subcutaneous AK006 or placebo, with the primary objective to evaluate safety, tolerability, and pharmacokinetics [3] - No serious adverse events were reported, and the most common mild-to-moderate adverse events were headache and dysmenorrhea [2][3] Group 2: Future Developments - Top-line results for intravenous AK006 in patients with chronic spontaneous urticaria (CSU) are expected in early Q1 of 2025, with data from approximately 30 patients anticipated [1][4] - The CSU arm of the Phase 1 study will randomize up to 60 adult patients to receive either 720 mg of IV AK006 or placebo every four weeks, with the primary efficacy analysis focusing on changes in the urticaria activity score [4] Group 3: Product Information - AK006 is a humanized IgG1 monoclonal antibody that activates the inhibitory receptor Siglec-6, selectively targeting mast cells involved in various diseases [5][7] - Preclinical studies indicate that AK006 can inhibit both IgE-dependent and IgE-independent mast cell activation, potentially reducing mast cell numbers through antibody-dependent cellular phagocytosis [5][7] Group 4: Company Overview - Allakos is a clinical-stage biotechnology company focused on developing therapeutics targeting immunomodulatory receptors on immune effector cells involved in allergy and inflammatory diseases [6][7] - The company aims to provide broad inhibition of inflammatory cells through its advanced antibody, AK006, which targets mast cells implicated in severe diseases affecting multiple organ systems [6][7]