Allakos Announces Results from a Phase 1 Study of Subcutaneously Administered Lirentelimab (AK002)

-- Subcutaneous formulation of lirentelimab was safe and well tolerated and demonstrated sustained eosinophil suppression supporting once monthly dosing --

REDWOOD CITY, CA, USA I October 26, 2020 I Allakos Inc. (the “Company”) (Nasdaq: ALLK), a biotechnology company developing lirentelimab (AK002) for the treatment of eosinophil and mast cell-related diseases, today announced results from a Phase 1 Study of subcutaneously administered lirentelimab in healthy volunteers. Based on these results, Allakos intends to investigate monthly dosing of the subcutaneous (SC) formulation of lirentelimab in patients with eosinophilic gastritis, eosinophilic duodenitis, eosinophilic esophagitis and other diseases.

Study Design: Phase 1 Subcutaneous Lirentelimab in Adult Healthy Volunteers
The randomized, double-blind, placebo-controlled, single dose, dose ranging Phase 1 Study was designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous lirentelimab in healthy volunteers over 85 days. Subjects enrolled in subcutaneously administered cohorts received a single SC dose of one of the following: 0.3, 1.0, 3.0, 5.0 mg/kg of lirentelimab, a 2 mL SC dose containing 300 mg of lirentelimab, or placebo. Bioavailability of SC lirentelimab was determined by comparing SC cohorts to cohorts that received intravenously (IV) administered lirentelimab.

Results: Phase 1 Subcutaneous Lirentelimab in Adult Healthy Volunteers
Bioavailability of SC lirentelimab was 63 percent. Subcutaneously administered lirentelimab resulted in extended eosinophil suppression at all dose levels tested. At dose levels of 3.0 and 5.0 mg/kg and with the fixed dose of 300 mg, SC lirentelimab resulted in eosinophil suppression in all subjects through Day 85.

Blood Eosinophil Levels Over Time



Route


Dose Cohort


n
Median Blood Eosinophils 103/mL
BL 1 hr 3 hr Day 15 Day 35 Day 56 Day 85
SC








Placebo 10 100 100 200 200 100 200 100
0.3 mg/kg 6 110 200 20 0 0 50 100
1.0 mg/kg 6 150 0 0 0 0 0 50
3.0 mg/kg 6 150 0 0 0 0 0 0
5.0 mg/kg 6 100 0 0 0 0 0 0
300 mg 6 100 0 0 0 0 0 0
IV
1.0 mg/kg 6 100 0 0 0 0 0 0
3.0 mg/kg 12 100 0 0 0 0 0 0

Subcutaneously administered lirentelimab was well tolerated. Across all SC and IV lirentelimab cohorts there were no serious adverse events, no injection site reactions, no injection reactions and no infusion-related reactions. One subject receiving placebo reported an injection reaction (mild flushing two hours post-injection).

Conference Call and Live Webcast
The Company will host a conference call and webcast with slides today at 8:00 a.m. Eastern Time / 5:00 a.m. Pacific Time. To participate by telephone, please dial 877-407-9039 (domestic) or 201-689-8470 (international). The conference ID number is 13712474. A live and archived audio webcast can be accessed through the Investors section of the Company's website at www.allakos.com. The archived audio webcast will remain available on the Company's website for 30 days following the conference call.

About Eosinophilic Gastritis, Eosinophilic Duodenitis, and Eosinophilic Esophagitis
Eosinophilic gastritis, eosinophilic duodenitis (previously referred to as eosinophilic gastroenteritis), and eosinophilic esophagitis are chronic, often severe, inflammatory diseases characterized by the presence of high levels of eosinophils in the stomach, duodenum, or esophagus, respectively. Common symptoms of the diseases include abdominal pain, nausea, diarrhea, bloating, cramping, early satiety, loss of appetite, vomiting, dysphagia, and weight loss. The current estimated prevalence of eosinophilic gastritis and eosinophilic duodenitis in the United States is approximately 50,000 people. The estimated prevalence of eosinophilic esophagitis in the United States is approximately 150,000 people. The Company believes that these diseases may be significantly under-diagnosed, or misdiagnosed, as other gastrointestinal diseases. There are no treatments approved specifically for these diseases. Treatment with systemic steroids can provide symptomatic improvement, but long-term treatment with steroids is generally not possible due to the numerous side effects. Allakos has received orphan drug designation for lirentelimab in eosinophilic gastritis, eosinophilic gastroenteritis, and eosinophilic esophagitis.

About Allakos
Allakos is a clinical stage biotechnology company developing antibodies that target immunomodulatory receptors present on immune effector cells involved in allergic, inflammatory, and proliferative diseases. The Company’s lead antibody, lirentelimab (AK002), is being evaluated in a Phase 3 study in eosinophilic gastritis (EG) and/or eosinophilic duodenitis (EoD) and a Phase 2/3 study in eosinophilic esophagitis (EoE). Lirentelimab targets Siglec-8, an inhibitory receptor selectively expressed on human mast cells and eosinophils. Inappropriately activated eosinophils and mast cells have been identified as key drivers in a number of severe diseases affecting the gastrointestinal tract, eyes, skin, lungs and other organs. Lirentelimab has been tested in multiple clinical studies. In these studies, lirentelimab eliminated blood and tissue eosinophils, inhibited mast cells and improved disease symptoms in patients with EG and/or EoD, EoE, mast cell gastrointestinal disease, severe allergic conjunctivitis, chronic urticaria and indolent systemic mastocytosis. For more information, please visit the Company's website at www.allakos.com.

SOURCE: Allakos

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