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Allakos Begins Clinical Trials of AK002 in Patients with Systemic Mastocytosis

Rare Proliferative Disease Marked by Excessive Accumulation of Mast Cells in Bone Marrow and Other Organs

SAN CARLOS, Calif., September 15, 2016 – Allakos, Inc. today announced it has initiated dosing of AK002 in a Phase 1 clinical trial in patients with systemic mastocytosis, a rare proliferative disease marked by abnormal accumulation of mast cells, which are key immune system cells involved in allergic and inflammatory responses. The open-label, single ascending-dose study, being conducted in Germany, will evaluate the safety, tolerability and pharmacokinetics of AK002 and will also offer the opportunity to assess markers of activity. AK002 is a therapeutic antibody intended for the treatment of severe diseases characterized by excess activity of mast cells and eosinophils.

"We are very excited that AK002 has entered clinical development, and are looking forward to joining doctors, patients and researchers attending this weekend’s Mastocytosis Society annual conference in Orlando to exchange information about this potentially life-threatening orphan disease,” said Chris Bebbington Ph.D., Chief Executive Officer of Allakos. “This is the second of our portfolio of antibodies to enter clinical trials. AK002 is specifically designed to reduce the number of mast cells, the immune cell type that is increased in patients with systemic mastocytosis. Currently, there are limited treatment options for patients with systemic mastocytosis, and Allakos is focused on rapidly developing novel therapies for patients that suffer from this difficult to manage disease."

Frank Siebenhaar, M.D., of the Department of Dermatology and Allergy, Charité – Universitätsmedizin Berlin, who, along with Professor Marcus Maurer, M.D., is a principal investigator for this study, commented: "Systemic mastocytosis is a serious disease for which there are no effective treatment options and current therapies primarily focus on managing symptoms. We are excited to collaborate with Allakos in the clinical evaluation of AK002 in patients with systemic mastocytosis."

Allakos is also conducting a Phase I healthy volunteer study with AK002 to further test the safety, pharmacokinetics and pharmacodynamics of this antibody. The study is anticipated to enroll up to 48 subjects. More information is available at https://clinicaltrials.gov/ct2/show/NCT02859701.

Allakos’ first antibody drug candidate, AK001, is currently under investigation in a Phase 2 study of patients with moderate to severe nasal polyposis with or without asthma. More information is available at https://clinicaltrials.gov/ct2/show/NCT02734849.

For further information on the AK002 systemic mastocytosis clinical trial, please visit https://clinicaltrials.gov/ct2/show/NCT02808793.

About Systemic Mastocytosis

Systemic mastocytosis is a disease characterized by excess proliferation of abnormal mast cells. Patients with the indolent form of systemic mastocytosis suffer from multiple mast cell-related symptoms such as severe itching, flushing, hives, abdominal pain and diarrhea and spontaneous anaphylaxis. The current treatments for these patients are focused on managing symptoms; there are no approved therapies that specifically target the underlying cause of the disease. In more aggressive forms of the disease, mast cells affect body organs and limit life expectancy.

About AK002

AK002 is a therapeutic antibody that selectively depletes mast cells and eosinophils. Binding of AK002 to specific receptors present on mast cells and eosinophils results in removal of these cells by a natural defense mechanism within the body called antibody-dependent cell-mediated cytotoxity (ADCC). AK002’s action is highly specific to mast cells and eosinophils and has potential to be of benefit in a wide spectrum of severe, often life-threatening, conditions. AK002 has demonstrated safety and efficacy activity in multiple pre-clinical models of disease prior to beginning clinical studies.

About Allakos

Allakos is a privately held, clinical-stage company developing a pipeline of novel therapeutics that selectively target mast cells and eosinophils – important immune effector cells that are involved in a broad spectrum of allergic and inflammatory conditions as well as several rare proliferative diseases with high unmet need. The company's lead drug candidates, AK001 and AK002 use novel approaches to target mast cells and eosinophils. AK001 is in a Phase 2 trial in patients with moderate to severe nasal polyposis with or without asthma, and AK002 is currently in two Phase 1 trials – 1) in healthy volunteers and 2) in patients with systemic mastocytosis. Allakos is located in San Carlos, California.

For further information, visit www.Allakos.com.


Allakos Contact
Simon Greenwood
Chief Business Officer
T: 650 597 5002

Media Contact
Nicole Litchfield, nicole@bioscribe.com
Joan Kureczka, joan@bioscribe.com

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