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 --

-- Management to host conference call and webcast today at 8:00 am ET --

REDWOOD CITY, Calif., Oct. 26, 2020 (GLOBE NEWSWIRE) -- 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