BMF-219 for Type 2 Diabetes

No longer recruiting at 50 trial locations

Overseen By Rima Sakhapara

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Biomea Fusion Inc.

Must be taking: Anti-diabetics

Must not be taking: Sulfonylureas, Insulin, DPP-4 inhibitors

Disqualifiers: Hypertension, MEN1, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new oral drug, BMF-219 (also known as Icovamenib or Covalent menin inhibitor), to evaluate its safety and effectiveness for people with Type 2 Diabetes. The study aims to understand the drug's interaction in the body and its impact on blood sugar levels in individuals with this condition. Participants may qualify if they have been diagnosed with Type 2 Diabetes within the last 15 years and are managing it with lifestyle changes and up to three stable medications. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

If you are taking certain anti-diabetes medications like sulfonylureas, insulin, or specific DPP-4 inhibitors (linagliptin and saxagliptin), you will need to stop them at least 2 months before joining the trial. Other medications may be allowed if they have been stable for at least 2 months prior to screening.

Is there any evidence suggesting that BMF-219 is likely to be safe for humans?

Research has shown that BMF-219, a new treatment for Type 2 Diabetes, is under study to determine its safety for people. Early results indicate that researchers are carefully testing BMF-219 to assess its tolerability. Participants are closely monitored for side effects, and researchers gather information to ensure safety.

Since the trial is in its early stages (Phase 1/2), the treatment is still under evaluation for safety and side effects. This phase is crucial to determine if the treatment is generally safe for further testing. While specific detailed safety data from current trials is not yet available, the main goal of these early phases is to ensure BMF-219's safety for human use.

Additionally, BMF-219 works by blocking a protein called menin, which helps the body manage insulin more effectively. This new approach is also under close observation for any safety issues. Overall, ongoing studies aim to confirm BMF-219's safety before advancing to the next development stages. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Type 2 Diabetes?

Researchers are excited about BMF-219 for type 2 diabetes because it represents a potentially novel approach compared to existing treatments like metformin, insulin, and GLP-1 receptor agonists. Unlike these standard treatments which primarily focus on managing blood sugar levels or enhancing insulin action, BMF-219 targets a different pathway that could provide unique benefits. Its distinct mechanism of action may offer improved glucose control or additional metabolic benefits that current therapies don't fully address. This innovative approach is why there's a buzz in the research community about its potential to change the landscape of diabetes management.

What evidence suggests that BMF-219 might be an effective treatment for Type 2 Diabetes?

Research has shown that BMF-219, an oral pill, might help treat Type 2 Diabetes. In previous studies, 89% of patients who took BMF-219 daily for four weeks experienced lower A1c levels. A1c measures average blood sugar over time, with lower numbers indicating better control. Another study found significant improvements in A1c levels after 26 weeks, following 8 to 12 weeks of taking the drug. This trial will include various treatment arms, such as the Phase 2 Expansion Cohort, where adults with Type 2 Diabetes will be randomized to receive either BMF-219 or a placebo. These findings suggest BMF-219 could effectively control blood sugar in people with Type 2 Diabetes. ^{1 2 3 6 7}

Who Is on the Research Team?

Biomea Fusion Inc.

Principal Investigator

Biomea Fusion Inc.

Are You a Good Fit for This Trial?

Adults aged 18-65 with Type 2 Diabetes Mellitus (T2DM) and a BMI of 25-40 kg/m^2, or healthy adults within the same age range but with a BMI of 18-35 kg/m^2. Participants must not be pregnant, should use contraception if applicable, and have stable health as determined by medical history and tests. Treated T2DM subjects may be on up to three anti-diabetic medications.

Inclusion Criteria

HbA1c ≥7.0% and ≤10% at screening.

Subjects with T2DM: Males with partners who are female with reproductive potential must agree to use effective contraceptive methods

BMI ≥18 and ≤40 kg/m2.

Exclusion Criteria

Healthy Subjects: History or evidence of HIV, HCV, HBV, or active COVID-19 infection

Healthy Subjects: Significant blood loss, blood donation, or blood transfusion within 2 months prior to dosing

Healthy Subjects: Seville oranges, grapefruit, grapefruit hybrids or grapefruit juice, pomelos, exotic citrus fruits or fruit juices ingestion or treatment with any CYP3A4 inhibitor, inducer, or substrate within a week prior to dosing

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Single Ascending Dose (SAD)

Participants receive single ascending doses of BMF-219 or placebo to evaluate safety, tolerability, PK, and PD

12 weeks

Multiple visits for dosing and assessments

Phase 2 Multiple Ascending Dose (MAD)

Participants receive multiple ascending doses of BMF-219 or placebo to evaluate safety, tolerability, PK, and PD

26 weeks

Regular visits for dosing and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

26 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BMF-219

Trial Overview The trial is testing BMF-219, an oral covalent menin inhibitor. It's a randomized, double-blind study comparing the effects of BMF-219 against a placebo in both healthy adults and those with T2DM to assess safety, tolerability, how the body processes it (pharmacokinetics), and its effectiveness (pharmacodynamics).

How Is the Trial Designed?

Group I: Phase 2 MAD Cohorts Experimental Treatment 1 Intervention

Phase 2 MAD Cohorts with healthy adults (MAD 1, randomized 3:1) or adults with T2D (MAD 2-4 \& 6-8, randomized 5:1) receiving BMF-219 or placebo. MAD 5 is BMF-219 only.

Group II: Phase 2 Expansion Cohort Experimental Treatment 1 Intervention

Phase 2 Expansion Cohort adults with T2D randomized 3:1 ratio receiving BMF-219 or placebo.

Group III: Phase 1 single dose tablet PK sub-study Experimental Treatment 1 Intervention

Phase 1 single dose x3 PK tablet open-label sub-study with healthy adults randomized 1:1 receiving BMF-219 or placebo fasted, with a low-fat meal, and with a high-fat meal).

Group IV: Phase 1 single dose food effect sub-study Experimental Treatment 1 Intervention

Phase 1 single dose food effect sub-study with healthy adults randomized 1:1:1:1:1:1 receiving BMF-219 or placebo fasted, with a low-fat meal, and with a high fat meal.

Group V: Phase 1 SAD Cohorts Experimental Treatment 1 Intervention

Phase 1 SAD Cohorts with healthy adults randomized 3:1 receiving BMF-219 or placebo. A pair of sentinel subjects (randomly assigned 1 active drug and 1 placebo) will be dosed 48 hours prior to dosing of the remainder of subjects in each cohort.

Who Is Running the Clinical Trial?

Biomea Fusion Inc.

Lead Sponsor

Trials

5

Recruited

780+

Citations

1. investors.biomeafusion.com investors.biomeafusion.com/news-releases/news-release-details/biomea-fusion-announces-positive-52-week-results-phase-ii

Biomea Fusion Announces Positive 52-Week Results from ... Icovamenib showed a sustained treatment benefit at Week 52 (9 months past the end of treatment) in the severe insulin-deficient diabetes ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05731544

NCT05731544 | Study of BMF-219 in Healthy Adult ... This is a Phase 1/ 2 study that will examine the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple dose levels of BMF ...

3. diabetesjournals.org diabetesjournals.org/diabetes/article/74/Supplement_1/272-OR/159649/272-OR-COVALENT-111-26-Week-Efficacy-and-Safety

272-OR: COVALENT-111: 26-Week Efficacy and Safety after 8 ... Conclusion: Icovamenib for 8 or 12 wks resulted in significant improvements in A1C at 26 wks in poorly controlled T2D.

4. investors.biomeafusion.com investors.biomeafusion.com/static-files/18ac5af2-6532-42a1-9062-9fad5d18c60f

QUICK FACTS - BMF-219 in Diabetes - Biomea Fusion After 4 weeks of once-daily 100 mg dosing with the investigational oral covalent menin inhibitor, BMF-219, 89% of patients achieved a reduction in A1c, 78% of ...

5. metabolismjournal.com metabolismjournal.com/article/S0026-0495(25)00090-3/fulltext

Investigating the Effects of Icovamenib on Poorly Managed ... Results: Case 1: 45-year-old male, 10-year T2D history. Received 100mg icovamenib daily. HbA1c decreased from 8.6% (baseline) to 7.5% (Week 26). Time in Range ...

6. sec.gov sec.gov/Archives/edgar/data/1840439/000119312524283008/d827448dex991.htm

EX-99.1 This study confirms the potential of menin inhibition as a novel mechanism for treating type 2 diabetes. Achieving a HbA1c reduction of this ...

7. investors.biomeafusion.com investors.biomeafusion.com/news-releases/news-release-details/biomea-fusion-highlights-initial-data-first-two-type-1-diabetes

Biomea Fusion Highlights Initial Data from the First Two Type ... BMF-219 is an investigational novel covalent menin inhibitor developed to regenerate insulin-producing beta cells with the aim to cure ...