US-based biopharmaceutical company Helicore Biopharma has dosed the first subject in a randomised, first-in-human Phase I trial of its humanised monoclonal antibody HCR-188 to treat obesity.
The study is both a single-ascending dose (SAD) and multiple-ascending dose (MAD) trial involving obese or overweight subjects who do not have diabetes mellitus.
Go deeper with GlobalData
It is being carried out at one site in Australia, with subjects expected to be involved in the study for nearly 20 weeks.
According to Helicore Biopharma, up to five MAD and five SAD cohorts could be enrolled, with several dosing regimens to be evaluated in the MAD portion.
The double-blind, placebo-controlled trial primarily aims to assess the antibody’s tolerability when given via subcutaneous injection at various dose levels.
It will also monitor the antibody’s impact on glucose-dependent insulinotropic peptide (GIP) and other metabolic and inflammatory markers, including glucose and lipids, as well as hormones that influence metabolism and calorie intake.
Helicore Biopharma CEO and president Gerrit Klaerner said: “Initiating this first-in-human study for GIP ligand binding with HCR-188, our humanised monoclonal antibody, is a significant milestone in the development of GIP ligand binding as a new mechanism of action in obesity treatment.
“While we do not expect to see efficacy signals for weight loss given the known time to onset of GIP antagonism, demonstrating the safety and tolerability of GIP ligand binders in this SAD/MAD study will establish the foundation for further advancement of our product portfolio.”
HCR-188 works by attaching to the circulating GIP ligand, which is expressed only by the small intestine’s K cells.
Due to this mechanism of action, Helicore Biopharma does not anticipate an ‘observable effect’ on weight loss over the four-week MAD treatment duration.
The company expects the trial’s top-line safety data to be ready in the second half of this year.
