Allakos has begun dosing of AK002 in a Phase 1 clinical trial in patients suffering with systemic mastocytosis, a rare proliferative disease marked by abnormal accumulation of mast cells that are also key immune system cells involved in allergic and inflammatory responses.
This is an open-label, single ascending-dose study being conducted in Germany.
The study will analyse the safety, tolerability and pharmacokinetics of AK002, as well as provide the opportunity to evaluate markers of activity.
AK002 is a therapeutic antibody meant for the treatment of severe diseases characterised by excess activity of mast cells and eosinophils.
Allakos CEO Chris Bebbington said: “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.
“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.
"There are currently 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.”
The firm is also carrying out a Phase I healthy volunteer study with AK002 to test the safety, pharmacokinetics and pharmacodynamics of this antibody.
The trial is expected to enrol up to 48 subjects.
Allakos’ first antibody drug candidate, AK001, is currently under investigation in a Phase 2 trial for patients with moderate-to-severe nasal polyposis with or without asthma.