Helicore Biopharma Begins Phase 1 Trial of Obesity Drug HCR-188

SOUTH SAN FRANCISCO, CA, USA I March 25, 2025 I Helicore Biopharma Inc., a company dedicated to developing innovative biopharmaceutical solutions, has commenced its first-in-human Phase 1 clinical trial for their pioneering treatment, HCR-188, aimed at combating obesity. This novel therapy, a monoclonal antibody, distinguishes itself by targeting the glucose-dependent insulinotropic peptide (GIP) ligand, rather than its receptor, marking a significant advancement in obesity treatment strategies.

The initiation of this clinical trial heralds a pivotal moment in Helicore's efforts to introduce a new mode of action in obesity therapy. Dr. Gerrit Klaerner, President and CEO of Helicore, emphasized the importance of the study, noting that while immediate weight loss effects are not anticipated due to the inherent latency associated with GIP antagonism, establishing the safety and tolerability of HCR-188 is crucial for future development.

HCR-188 functions by binding to the circulating GIP ligand, which is uniquely expressed by K cells located in the small intestine. This binding action potentially decreases the amount of GIP available to interact with its receptors throughout the body, including in adipose tissue and deep brain regions. By reducing GIP availability, HCR-188 could prevent GIP signaling within the brain, possibly restoring leptin sensitivity. Such restoration might lead to increased feelings of satiety, reduced food intake, and less fat accumulation.

The Phase 1 trial is structured as a randomized, double-blind, placebo-controlled investigation. It involves both single ascending dose (SAD) and multiple ascending dose (MAD) methodologies. Participants in the study are overweight or obese individuals who do not suffer from diabetes mellitus. The main objective is to assess the safety and tolerability of HCR-188 when administered through subcutaneous injections at various dosage levels. Beyond safety, the study will explore the pharmacokinetic profile of HCR-188 and its effects on GIP levels, as well as its influence on various metabolic and inflammatory markers, including lipids, glucose, and hormones related to metabolism and energy consumption.

Although significant weight loss is not expected within the four-week MAD treatment phase due to the novel mechanism of HCR-188, the trial will provide valuable insights into the drug's interaction with its target and its impact on metabolic health indicators. Helicore anticipates releasing top-line safety data in the latter half of 2025, which will offer further direction for their research and development efforts.

Helicore Biopharma, the driving force behind this innovative therapeutic approach, is committed to advancing a modular platform of anti-obesity medications. Their strategy leverages monoclonal antibodies that bind circulating GIP ligand, which could enhance drug efficacy, improve dosing regimens, and increase tolerability among patients. Helicore's pioneering work in this domain underscores their dedication to addressing obesity and its related health challenges through scientific innovation and rigorous clinical testing.