BMF-219 for Type 1 Diabetes

(BF-MNN-112 Trial)

Recruiting at 30 trial locations

Overseen By Sanchita Mourya

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Biomea Fusion Inc.

Must be taking: Insulin

Must not be taking: PPIs, CYP3A4 drugs

Disqualifiers: MODY, T2D, Cardiovascular disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

190 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests BMF-219, an oral medication that blocks a protein called menin, in people with Type 1 Diabetes. The goal is to see if it can help their insulin-producing cells work better and improve how their bodies handle sugar and fats.

Do I need to stop my current medications to join the trial?

The trial requires that you have only been treated with insulin for at least 2 months before screening and prohibits the use of other diabetes medications during that time. Additionally, you cannot use proton pump inhibitors or certain other medications that affect liver enzymes within a week before starting the trial.

How is the drug BMF-219 different from other treatments for type 1 diabetes?

BMF-219, also known as Icovamenib, is unique because it is a covalent menin inhibitor, which is a different mechanism of action compared to other treatments like insulin or SGLT inhibitors used in type 1 diabetes. This novel approach targets a specific protein involved in disease pathways, potentially offering a new way to manage the condition. ^{1 2 3 4 5}

Research Team

Juan Pablo Frias, MD

Principal Investigator

Biomea Fusion Inc.

Eligibility Criteria

Adults aged 18-60 with Type 1 Diabetes diagnosed within the last 3 years are eligible for this trial. They must be using only insulin to manage their diabetes, have an HbA1c level between 6.5% and 10%, a BMI of up to 40 kg/m2, and certain levels of C-peptide.

Inclusion Criteria

Your C-peptide concentration is equal to or greater than 0.2 nmol/L (0.60 μg/L).

If your C-peptide level is between 0.15 to 0.20 nmol/L when fasting, but goes above 0.20 nmol/L after a test, you may still be eligible.

If you were diagnosed within the last 3 years and your C-peptide level is equal to or greater than 0.2 nmol/L (0.60 μg/L), you can participate. If your fasting C-peptide level is between 0.15 to 0.20 nmol/L (0.45 to 0.60 μg/L), a stimulated C-peptide level greater than 0.20 nmol/L (0.60 μg/L) is also acceptable.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BMF-219 or placebo for 12 weeks in a randomized, double-blind, placebo-controlled design

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of insulin secretion and hypoglycemic events

26 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

Treatment Details

Interventions

• BMF-219

Trial Overview The trial is testing BMF-219 in people with Type 1 Diabetes to see how effective it is. Participants will receive BMF-219 under controlled conditions to monitor its impact on their blood sugar control and overall health.

Participant Groups

Group I: Part 2 Experimental Treatment 1 Intervention

Part 2 Part 2 uses a randomized, double-blind, placebo-controlled design with parallel assignment among 3 treatment arms. Eligible participants will be randomly assigned to 1 of 3 arms using a 1:1:1 ratio: * Arm A: BMF-219 100 mg QD for 12 weeks * Arm B: BMF-219 200 mg QD for 12 weeks

Group II: Part 1 Experimental Treatment 1 Intervention

Part 1 uses a randomized, open-label design with parallel assignment between 2 treatment arms in each cohort. The Part 1 Eligible participants will be randomly assigned by cohort to 1 of 2 treatment arms: * Cohort 1: Participants with T1D diagnosed within 3 years with C-peptide concentration ≥0.2 nmol/L * Arm A: BMF-219 100 mg QD for 12 weeks * Arm B: BMF-219 200 mg QD for 12 weeks * Cohort 2: Participants with T1D diagnosed between 3 to 15 years with C-peptide concentration ≥0.08 nmol/L. * Arm A: BMF-219 100 mg QD for 12 weeks * Arm B: BMF-219 200 mg QD for 12 weeks

Group III: Placebo Comparator Placebo Group 1 Intervention

Part 2 Study Double Blind Arm C matching placebo for 12 weeks.

Who Is Running the Clinical Trial?

Biomea Fusion Inc.

Lead Sponsor

Trials

5

Recruited

780+

Findings from Research

Sotagliflozin significantly improves glycemic control in adults with type 1 diabetes, reducing HbA1c levels and insulin requirements while also enhancing time in the target glucose range, based on a meta-analysis of six trials involving 3,238 participants over 4 to 52 weeks.

While sotagliflozin reduces the incidence of hypoglycemia, it does increase the risk of diabetic ketoacidosis and other side effects, indicating that careful patient management and insulin dose adjustments are necessary to mitigate these risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of dual SGLT 1/2 inhibitor sotagliflozin in type 1 diabetes: meta-analysis of randomised controlled trials. Musso, G., Gambino, R., Cassader, M., et al.[2022]

In a phase 3 trial with 1402 patients, those taking sotagliflozin alongside insulin therapy had a significantly higher rate of achieving a glycated hemoglobin level below 7.0% compared to the placebo group (28.6% vs. 15.2%).

While sotagliflozin improved glycemic control and reduced weight and insulin dosage, it was associated with a higher rate of diabetic ketoacidosis (3.0% vs. 0.6% in the placebo group), indicating a need for careful monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Sotagliflozin Added to Insulin in Patients with Type 1 Diabetes. Garg, SK., Henry, RR., Banks, P., et al.[2022]

Only 20% of patients with type 1 diabetes achieve adequate control despite advancements in insulin delivery and monitoring, highlighting a significant need for innovative treatments.

Pramlintide is currently the only approved adjunct therapy for type 1 diabetes, while dapagliflozin and sotagliflozin have shown efficacy in reducing HbA1c without increasing hypoglycemia risk, although they are not yet licensed in the U.S. due to concerns about diabetic ketoacidosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjunct therapies in treatment of type 1 diabetes. Goyal, I., Sattar, A., Johnson, M., et al.[2021]

In a 29-week study involving 296 patients with type 1 diabetes, pramlintide combined with reduced mealtime insulin effectively decreased postprandial glucose levels and weight, while both pramlintide and placebo groups showed similar reductions in HbA1c levels.

Although nausea was more common in the pramlintide group, it was mostly mild to moderate, and the rates of severe hypoglycemia were low in both groups, indicating that pramlintide can be a safe adjunct therapy for managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A double-blind, placebo-controlled trial assessing pramlintide treatment in the setting of intensive insulin therapy in type 1 diabetes. Edelman, S., Garg, S., Frias, J., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Sotagliflozin in Combination With Optimized Insulin Therapy in Adults With Type 1 Diabetes: The North American inTandem1 Study. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of dual SGLT 1/2 inhibitor sotagliflozin in type 1 diabetes: meta-analysis of randomised controlled trials. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of Sotagliflozin Added to Insulin in Patients with Type 1 Diabetes. [2022]

4. Australia pubmed.ncbi.nlm.nih.gov

Adjunct therapies in treatment of type 1 diabetes. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

A double-blind, placebo-controlled trial assessing pramlintide treatment in the setting of intensive insulin therapy in type 1 diabetes. [2022]