Allakos announces results from AK006 study

Allakos announced results from the Phase 1 study of subcutaneous AK006 in healthy volunteers. AK006 is a Siglec-6 monoclonal antibody that selectively inhibits mast cells. Inappropriate activation of mast cells has been identified as a pathogenic driver of multiple diseases, including chronic spontaneous urticaria, food allergy and asthma. Bioavailability of subcutaneous AK006 was approximately 77%. Subcutaneous administered AK006 showed an estimated half-life of 12-22 days. Consistent with the IV formulation, skin biopsies taken from subcutaneous AK006 treated healthy volunteers showed high levels of receptor occupancy confirming AK006 reaches skin tissue mast cells. The 720 mg dose of AK006 showed 98% receptor occupancy at day 113 suggesting the potential for infrequent dosing. Single and multiple doses of IV AK006 and single dose subcutaneous AK006 up to 720 mg were well-tolerated with a favorable safety profile. In the safety profile to date: There were no serious adverse events, or SAEs, in subjects on AK006. There were no treatment emergent adverse events leading to discontinuation of AK006. There were no dose limiting toxicities. The most common adverse events occurring more frequently in subjects on AK006 were headache and dysmenorrhea, all of which were mild-to-moderate in severity.