Allakos Announces Positive Phase 2 Results in Patients with Cholinergic Urticaria and Symptomatic Dermographism
-- 82% (9 of 11) response rate in patients with cholinergic urticaria --
-- 70% (7 of 10) response rate in patients with symptomatic dermographism --
“We are excited by these data especially since there are no approved treatments for patients with cholinergic urticaria and symptomatic dermographism. Furthermore, the activity observed in patients with CSU and these patient cohorts suggests that AK002 may be used across multiple types of urticaria,” said principal investigator of the study, Dr.
The study is being conducted at four sites in the U.S. and
Top-line data are presented below; more detailed results from the study will be presented at an upcoming medical conference.
|Cholinergic Urticaria Cohort||Baseline||Week 22|
|Average UCT Score||5.4||11.8|
|UCT Complete Response||-||9/11 (82%)|
|UCT Partial Response||-||0/11 (0%)|
|UCT No Response||-||2/11 (18%)|
|Symptomatic Dermographism Cohort|
|Average UCT Score||5.7||9.1|
|UCT Complete Response||-||4/10 (40%)|
|UCT Partial Response||-||3/10 (30%)|
|UCT No Response||-||3/10 (30%)|
*UCT is an established patient-reported outcome scale for assessing urticaria control and measuring key symptoms.
UCT is a scale between 0 and 16, with higher scores indicating greater urticaria control.
UCT Complete Response was defined as a greater than 3-point improvement from baseline and a score of 12 or greater. UCT Partial Response was defined as a greater than 3-point improvement from baseline but less than 12.
AK002 was generally well tolerated. The most common adverse event was mild to moderate infusion-related reactions (flushing, feeling of warmth, headache, nausea, and dizziness) which occurred mostly during the first infusion.
Phase 2 Chronic Urticaria Study
The open-label Phase 2 study is being conducted at four sites in the U.S. and
About Chronic Urticarias
Chronic urticarias are a group of inflammatory skin diseases that are believed to be caused by the inappropriate activation of the mast cells in the skin. Symptoms of urticaria include severe itching, hives, and edema with symptoms lasting for many years. Whereas there is no identified trigger for chronic spontaneous urticaria, other chronic urticarias are caused by triggers such as physical contact with the skin (symptomatic dermographism), or passive or active increases in body temperature (cholinergic urticaria). It has been estimated that 0.5 to 1.0 percent of the U.S. population suffers from a form of chronic urticaria. First-line treatment consists of antihistamine medication, however a significant number of patients do not receive adequate benefit even at four times the labeled dose. Xolair is the only agent approved for antihistamine refractory chronic spontaneous urticaria but is not indicated for other forms of chronic urticaria.
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, AK002, 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. AK002 has completed two Phase 1 trials, one in healthy volunteers and a single ascending dose trial in patients with indolent systemic mastocytosis. AK002 demonstrated pharmacodynamic activity in both trials and in the trial involving patients with indolent systemic mastocytosis, patients reported improvements in their symptoms. AK002 is being tested in a double-blind, placebo-controlled Phase 2 trial for the treatment of eosinophilic gastritis and eosinophilic gastroenteritis. In addition, Allakos is conducting multiple-dose trials with AK002 in chronic urticaria, indolent systemic mastocytosis, and severe allergic conjunctivitis. For more information, please visit the Company's website at www.allakos.com.
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, the timing of top-line results from Allakos’ ongoing clinical trials. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from current expectations and beliefs, including but not limited to: Allakos’ early stages of clinical drug development; Allakos’ ability to timely complete clinical trials for, and if approved, commercialize AK002, its lead compound; Allakos’ ability to obtain required regulatory approvals for its product candidates; uncertainties related to the enrollment of patients in its clinical trials; Allakos’ ability to demonstrate sufficient safety and efficacy of its product candidates in its clinical trials; uncertainties related to the success of later-stage clinical trials, regardless of the outcomes of preclinical testing and early-stage trials; market acceptance of Allakos’ product candidates; uncertainties related to the projections of the size of patient populations suffering from the diseases
Adam Tomasi, COO, CFO firstname.lastname@example.org Media Contact: Denise Powelldenise@redhousecomms.com
Source: Allakos Inc.