MBX Biosciences Doses First Participant in Phase 1 Trial of Obesity Treatment

By Tamara Parker • Thursday, September 04 15:35 • Permanent Link

MBX Biosciences, Inc. (NASDAQ: MBX) has reached a significant milestone by dosing the first participant in its phase 1 trial of MBX 4291, a precision endocrine peptide™ (PEP™) glucagon-like peptide-1 (GLP-1)/ glucose-dependent insulinotropic polypeptide (GIP) co-agonist prodrug candidate for the treatment of obesity. The company's President and CEO, Kent Hawryluk, expressed excitement over this development and highlighted the potential for improved weight loss and better gastrointestinal tolerability with once-monthly administration of MBX 4291.

The phase 1 trial is a randomized, double-blind, placebo-controlled first-in-human study aimed at evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of MBX 4291 in adult participants with obesity. The trial consists of two parts: single ascending dose (SAD) and multiple ascending dose (MAD) over 4 weeks. Following the completion of these parts, the company plans to evaluate multiple ascending doses of MBX 4291 administered over 12 weeks in up to two cohorts.

MBX 4291 is an investigational long-acting GLP-1/GIP receptor co-agonist prodrug candidate designed to provide improved tolerability, increased adherence to treatment at maximum efficacious doses, and to achieve greater long-term weight loss and improvement in weight-related comorbidities. In preclinical studies, the active component of MBX 4291 demonstrated a similar activity profile and body weight loss as tirzepatide, an approved weekly GLP-1/GIP co-agonist, with the potential for once-monthly administration due to its extended duration of action.

MBX Biosciences is focused on the discovery and development of novel precision peptide therapies for the treatment of endocrine and metabolic disorders. In addition to MBX 4291, the company's pipeline includes other candidates such as canvuparatide (MBX 2109) for the treatment of chronic hypoparathyroidism (HP) in phase 2 development, and imapextide (MBX 1416) for the treatment of post-bariatric hypoglycemia (PBH) in phase 2 development.

This progress signifies an important step in addressing the global public health issue of obesity, and the company anticipates topline results from the phase 1 trial in 2027. Following these announcements, the company's shares moved -6.11%, and are now trading at a price of $13.52. For more information, read the company's full 8-K submission here.

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