MBX 4291 / MBX Biosci - LARVOL DELTA

Initial Phase 1 data for MBX 4291 supports potential for once-monthly dosing (The Manila Times) - "Preliminary blinded data from the ongoing Phase 1 trial of MBX 4291, a dual GLP-1/GIP receptor agonist peptide prodrug, in adults with obesity demonstrated mean weight loss of 7% (range, 0-16%) at eight weeks (n=8, including 2 placebo) in the first multiple ascending dose (MAD) Part B cohort, with MBX 4291 generally well tolerated through eight weeks. The Company remains on track to report data from the first cohort of the 12-week MAD (Part C) in Q4 2026. Cohort C1 is evaluating a 30 mg (once-weekly x 4) + 120 mg (once-monthly) + 180 mg (once-monthly) titration regimen in adult participants with obesity (BMI ≥ 30)."

P1 data • Obesity

MBX 4291 and Expanding Obesity Pipeline (GlobeNewswire) - "MBX announced plans to host an Obesity Day on May 11, 2026, featuring initial blinded data from the ongoing Phase 1 trial of MBX 4291 and an update on its expanding obesity pipeline...The Company remains on track to report data from the 12-week multiple ascending dose (MAD) portion of the ongoing Phase 1 trial of MBX 4291 in Q4 2026....MBX plans to nominate additional obesity development candidates enabled by its PEP platform, each designed for potential once-monthly dosing with improved tolerability. These candidate nominations include an amycretin prodrug, on track for this quarter, and a GLP-1/GIP/glucagon receptor (GCGR) triple-agonist prodrug, expected in Q3 2026."

P1 data • Pipeline update • Obesity

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MBX 4291 in Adult Participants With Obesity (clinicaltrials.gov) - P1 | N=124 | Recruiting | Sponsor: MBX Biosciences | N=64 ➔ 124 | Trial completion date: May 2026 ➔ Oct 2026 | Trial primary completion date: May 2026 ➔ Oct 2026

Enrollment change • First-in-human • Trial completion date • Trial primary completion date • Genetic Disorders • Obesity

MBX4291 and Early Pipeline Programs for Obesity (GlobeNewswire) - "MBX 4291 advancing through Phase 1: MBX 4291, a GLP-1/GIP co-agonist prodrug designed for potential once-monthly dosing, continues to advance through Phase 1, with 12-week multiple ascending dose data on track to be reported in Q4 2026....MBX expects to nominate two additional obesity development candidates enabled by its PEP platform, each designed for potential once-monthly dosing with improved tolerability, including an amycretin prodrug targeted for nomination in Q2 2026 and a GLP-1/GIP/glucagon receptor (GCGR) triple-agonist prodrug candidate targeted for nomination in Q3 2026."

P1 data • Pipeline update • Obesity

MBX 4291 and Early Pipeline Programs for Obesity (GlobeNewswire) - "MBX 4291, a glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic peptide (GIP) co-agonist prodrug with potential for once-monthly dosing, continues to progress through Phase 1 evaluation, with 12-week multiple ascending dose data expected in Q4 2026; MBX expects to expand its obesity portfolio in 2026 with two additional candidates designed to address the full spectrum of needs for patients with obesity, each with once-monthly dosing. These include an amycretin prodrug and a GLP-1/GIP/glucagon receptor (GCGR) prodrug candidate, with nominations anticipated in Q2 and Q3 2026."

P1 data • Pipeline update • Obesity

Obesity: MBX 4291 (GlobeNewswire) - "Planned 12-week MAD portion: Following completion of Parts A and B, the Company plans to evaluate multiple ascending doses of MBX 4291, or matching placebo, administered over 12 weeks in up to two cohorts consisting of 30 participants each in a 2:1 randomization ratio. Participants are expected to receive up to a total of 12 study intervention administrations one week or one week and one month apart with increasing doses of MBX 4291 and will be followed for 120 days after the first dose. Results from the planned 12-week MAD portion are expected in Q4 2026."

P1 data • Trial status • Obesity

MBX Biosciences Doses First Participant in Phase 1 Trial of MBX 4291 for the Treatment of Obesity (GlobeNewswire) - "The Phase 1 trial is a randomized, double-blind, placebo-controlled first-in-human study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of MBX 4291 in adult participants with obesity."

Trial status • Obesity

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MBX 4291 in Adult Participants With Obesity (clinicaltrials.gov) - P1 | N=64 | Recruiting | Sponsor: MBX Biosciences

New P1 trial • Genetic Disorders • Obesity

MBX Biosciences Announces IND Submission of MBX 4291, its Long-acting GLP1/GIP Receptor Co-agonist Prodrug for the Treatment of Obesity (GlobeNewswire) - "MBX Biosciences...announced submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for MBX 4291, a long-acting glucagon-like peptide-1 (GLP-1)/ glucose-dependent insulinotropic polypeptide (GIP) receptor co-agonist prodrug for the treatment of obesity....'Following IND clearance, we plan to initiate a Phase 1 trial evaluating MBX 4291 in healthy overweight volunteers in the third quarter of 2025'."

IND • New P1 trial • Obesity

MBX Biosciences Reports First Quarter 2025 Financial Results and Recent Corporate Highlights (GlobeNewswire) - "IND application submission on track for Q2 2025: MBX 4291, a GLP-1/GIP co-agonist prodrug, is being developed as a once-monthly treatment for obesity. The Company expects to submit an IND application for MBX 4291 this quarter."

IND • Obesity

MBX 4291: IND filing on track for Q2 2025 (GlobeNewswire) - "MBX expects to submit an IND application to the FDA in the second quarter of 2025 for MBX 4291, the Company’s GLP-1/GIP co-agonist prodrug for the potential once-monthly treatment of obesity."

IND • Obesity