Biotechnology company Apogee Therapeutics has announced positive Phase I data for its antibody APG333. 

APG333, a novel half-life extended TSLP antibody, has been developed for inflammatory and immunology (I&I) markets. In the double-blind, placebo-controlled, first-in-human Phase I clinical trial, APG333 was well tolerated across all cohorts of 32 healthy volunteers. 

The study indicates the potential for APG333 to support three- to six-month dosing based on a half-life of approximately 55 days across doses tested. APG333 was administered in doses up to 1,000 mg. 

Michael Henderson, Chief Executive Officer of Apogee, said the results show Apogee’s antibody approach “continues to deliver durable activity” and could improve “adherence and outcomes for patients.” 

“The extended PK and favourable tolerability profile of APG333 underscores Apogee’s potential to advance a quarterly or better dosing combination of APG777 and APG333, designed to address key drivers of respiratory diseases more broadly than a monotherapy.” 

“APG333’s PK profile supports the potential for dosing two to four times a year, a significant advancement over the current standard of care,” added Carl Dambkowski, Chief Medical Officer of Apogee.   

“These data unlock our combination of APG777 and APG333, which together demonstrated suppression of complementary pathways implicated in obstructive airway disease and may enable quarterly or less frequent dosing, expanding options for patients with limited available treatments.” 

Bruno Quinney, Content Team, DDW