Allakos, Inc. has initiated a phase 2 clinical trial of AK001, its lead therapeutic antibody, in patients with nasal polyposis with and without asthma. This multicenter trial with sites in the US and Europe will evaluate the activity of two dose levels of AK001 compared with placebo. Study results are anticipated in the second half of 2017. AK001 is a therapeutic antibody currently in development for the treatment of severe inflammatory and allergic diseases characterized by excess activity of mast cells and eosinophils.
"Advancing AK001 into a phase 2 clinical trial in patients is an important milestone for Allakos as we continue clinical development of our therapeutic antibody pipeline," said Chris Bebbington Ph.D., chief executive officer of Allakos. "The rapid and efficient initiation of this international trial is a great reflection on the abilities of the Allakos development team. The novel mechanism by which AK001 works is ideally suited for the treatment of nasal polyps, which are highly enriched for eosinophils and mast cells. Currently, there are limited therapeutic options for patients with nasal polyposis and, if successful, AK001 may offer a safe and effective non-surgical approach to the disease."
The multicenter, randomized, double blind, placebo-controlled study will enroll 70 patients with moderate to severe nasal polyposis with and without asthma at sites in both the US and Europe.
Nasal polyposis is a disease characterized by the growth of polyps in the nasal cavities. In the majority of patients, these polyps are highly enriched for mast cells and eosinophils. Patients with nasal polyposis have blocked nasal passages and sinuses with obstructed breathing and impaired sense of taste and smell that can result in a significant impact on quality of life. These patients are also prone to recurrent nasal infections and asthma, which can be severe in nature. Nasal polyposis is difficult to control with current treatment options, which include topical steroids and surgery.
AK001 is a therapeutic antibody that selectively targets mast cells and eosinophils. Binding of AK001 to specific receptors present on mast cells and eosinophils results in the inhibition of mast-cell inflammatory signaling and the removal of tissue-based eosinophils. The direct effect of AK001 on mast cells and eosinophils bypasses the redundancy of cytokine signaling pathways without directly affecting other cells of the immune system. AK001 has the potential to be of benefit in a wide spectrum of severe inflammatory and allergic diseases. Allakos has demonstrated activity of AK001 in multiple pre-clinical models and completed a phase I clinical trial with AK001 in healthy volunteers in which it was well tolerated and demonstrated pharmacodynamic activity.