BMF-650 / Biomea Fusion - LARVOL DELTA

Next-generation Oral Small Molecule GLP-1 RA Product Candidate for Obesity (GlobeNewswire) - "GLP-131, a Phase I randomized, double-blind, placebo-controlled clinical trial evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMF-650 in otherwise healthy overweight or obese participants is ongoing; The Company expanded its Phase I BMF-650 trial to evaluate a rapid one-step titration and enhanced weight loss potential with its oral GLP-1 receptor agonist; Initial 28-day clinical weight reduction data from the Phase I GLP-131 clinical trial is anticipated in the third quarter of 2026."

P1 data • Trial status • Obesity

Biomea Expands Ongoing Phase I BMF-650 Study to Optimize Dose Selection for Phase II Development (GlobeNewswire) - "Biomea has completed the single ascending dose ('SAD') portion and four multiple ascending dose ('MAD') cohorts of the ongoing GLP-131 Phase I study evaluating BMF-650, the Company’s next-generation oral small molecule GLP-1 RA, in otherwise healthy overweight or obese participants...Based on the favorable safety and tolerability profile observed to date, as well as emerging pharmacokinetic and clinical observations, the Company has elected to add an additional MAD cohort to evaluate a rapid one-step titration (200 mg QD for 1 week, then 400 mg QD for 3 weeks) and to further optimize the weight reduction potential achievable with Biomea’s investigational oral GLP-1 RA...Initial 28-day clinical weight reduction data from the Phase I GLP-131 study is anticipated in the third quarter of 2026."

P1 data • Trial status • Obesity

Next-generation Oral Small Molecule GLP-1 RA Product Candidate for Obesity (GlobeNewswire) - "Initial 28-day clinical weight reduction data from the Phase I GLP-131 clinical trial is anticipated in the second quarter of 2026."

P1 data • Obesity

Study of BMF-650 in Otherwise Healthy Overweight or Obese Adult Participants (clinicaltrials.gov) - P1 | N=80 | Active, not recruiting | Sponsor: Biomea Fusion Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • First-in-human • Genetic Disorders • Obesity

BMF-650 Next-generation Oral Small Molecule GLP-1 RA Product Candidate for Obesity (Yahoo Finance) - "Initial 28-day clinical weight reduction data from the Phase I GLP-131 study is anticipated in the second quarter of 2026."

P1 data • Obesity

Biomea’s anticipated 2026 milestones include (GlobeNewswire) - "Anticipate completion of additional preclinical studies in relevant diabetes models to further evaluate the potential of icovamenib and BMF-650 across selected diabetes and obesity subpopulations."

Preclinical • Obesity • Type 2 Diabetes Mellitus

GLP-131, Phase I, BMF-650 in obese, otherwise healthy volunteers, with completion of single- and multiple-ascending dose cohorts and final 28-day weight-loss data expected in the second quarter of 2026. (GlobeNewswire)

P1 data • Obesity

Preclinical Efficacy of BMF-650 An Oral Small Molecule GLP-1 Receptor Agonist (OBESITY WEEK 2025) - "BMF-650 is a potent, biased agonist of the human GLP-1R. In-vivo, BMF-650 induced efficient GSIS and glucose reduction in cynomolgus monkeys. In a weight loss study in obese monkeys, BMF-650 was well tolerated and showed significant and dose dependent weight reduction of 12% and 15% at the end of the 28 days oral dosing period."

Preclinical • Genetic Disorders • Obesity

Title: Preclinical Efficacy of BMF-650, an Oral Small-Molecule GLP-1 Receptor Agonist (GlobeNewswire) - "Biomea Fusion Showcases Preclinical Advances for BMF-650...at ObesityWeek 2025....Key Findings: Potent and biased GLP-1 receptor agonism; Strong incretin response with robust insulin release in intravenous glucose tolerance test studies; Oral bioavailability of 33% in rats and 54% in monkeys, exceeding that of orforglipron under matched conditions....BMF-650 is currently in a Phase I study in healthy obese patients with 28-day weight loss data expected in the first half of 2026."

P1 data • Preclinical • Obesity

Biomea Fusion to Present Poster Presentations at ObesityWeek 2025 (GlobeNewswire) - "The presentations will highlight preclinical data for BMF-650, Biomea’s next-generation oral small molecule glucagon-like peptide-1 ('GLP-1') receptor agonist ('RA'), and combination data for icovamenib, the company’s first-in-class covalent menin inhibitor, with semaglutide, a GLP-1 based therapy."

Preclinical • Obesity

Study of BMF-650 in Otherwise Healthy Overweight or Obese Adult Participants (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: Biomea Fusion Inc.

New P1 trial • Genetic Disorders • Obesity

Biomea Fusion Announces First Patient Dosed in Phase I Study of BMF-650 a Next-Generation Oral GLP-1 Receptor Agonist (GlobeNewswire) - "The Phase I clinical trial will assess the safety, tolerability, and preliminary efficacy of BMF-650 in otherwise healthy overweight or obese participants, with 28-day weight loss data at the highest dose expected in the first half of 2026."

P1 data • Trial status • Obesity

In preclinical studies with obese cynomolgus monkeys, once-daily oral administration of BMF-650 (10 mg/kg and 30 mg/kg) resulted in clear, dose-dependent reductions in daily food intake and continuous, progressive weight loss over a 28-day treatment period. (GlobeNewswire) - "Animals receiving 10 mg/kg and 30 mg/kg doses achieved average body weight reductions of approximately 12% and 15%, respectively, from baseline."

Preclinical • Obesity

…Biomea also announced progress of its BMF-650 program (GlobeNewswire) - "Initiation of a Phase I clinical trial in obesity is on track with 28-day weight loss data expected in the first half 2026."

New P1 trial • Obesity

Biomea Fusion Reports Second Quarter 2025 Financial Results and Corporate Highlights (GlobeNewswire) - "Key Anticipated 2025 Milestones:...BMF-650 (Next-generation Oral Small Molecule GLP-1 RA for Obesity): (i) Submission of the IND application for BMF-650 is planned for the second half of 2025; (ii) Phase I study initiation in obese, otherwise healthy volunteers anticipated by late 2025, pending regulatory clearance."

IND • New P1 trial • Obesity

Biomea Fusion Reports Preclinical Data for BMF-650, a Next-Generation Oral GLP-1 Receptor Agonist Candidate, Demonstrating Robust Weight Loss and Appetite Suppression in Obese Non-Human Primates (GlobeNewswire) - "Biomea Fusion...announced new preclinical findings from a 28-day weight loss study in obese non-human primates evaluating BMF-650....The study demonstrated a clear, dose-dependent reduction in daily food intake and pronounced and continuous weight loss over a 28-day treatment period. BMF-650 was administered orally once daily at 10 mg/kg and 30 mg/kg and resulted in marked reductions in food intake and progressive body weight reductions, with the respective dose groups achieving a 12% and 15% average weight reduction from baseline over 28 days....A full set of preclinical data for BMF-650 is planned for submission and presentation at an upcoming medical conference....IND filing on track for the second half of 2025; with Phase I study initiation in obese, otherwise healthy volunteers anticipated late 2025."

IND • New P1 trial • Preclinical • Obesity

Biomea Fusion Reports First Quarter 2025 Financial Results and Corporate Highlights (GlobeNewswire) - "Key Anticipated 2025 Milestones:...BMF-650 (Next-generation Oral Small Molecule GLP-1 Receptor Agonist for Obesity): Submission of the Investigational New Drug ('IND') application for BMF-650 planned for the second half of 2025."

IND • Obesity

Biomea Fusion…Introduces BMF-650, a Next-Generation, Oral Small-Molecule GLP-1 Receptor Agonist Candidate (GlobeNewswire) - "We conducted preclinical studies to evaluate the properties of BMF-650 in comparison to a leading oral GLP-1 RA. BMF-650 exhibited higher bioavailability and a less variable pharmacokinetic profile, which may translate to improved tolerability and support successful dose escalation in patients. The estimated human dose will be approximately 100 mg once daily; In human donor islet studies, BMF-650 significantly enhanced glucose-stimulated insulin secretion. In cynomolgus monkey studies, BMF-650 showed significant improvements in glucose stimulated insulin secretion, in line with findings from the human donor islet experiments. BMF-650 also demonstrated superior glucose control; Appetite suppression studies revealed that daily oral BMF-650 dosing significantly reduced food intake during peak drug concentration, with sustained effects throughout the day for a six-day study period; These findings highlight BMF-650’s potential as an oral treatment for diabetes and obesity."

New molecule • Preclinical • Diabetes • Metabolic Disorders • Obesity